The retrospective, propensity-matched cohort study analyzed the effects of SGLT2 inhibitors on AF recurrence in patients with type 2 DM who have received ablation for AF with use of data from the TriNetX Analytics Network database. Participants were aged 18 years or older with a history of type 2 DM and ablation for AF from April 1, 2014, to November 30, 2021.

The main composite outcome was the need for cardioversion, new class I or III antiarrhythmic drug (AAD) therapy, or re-do AF ablation after a 3-month blanking period following the index AF ablation. Participants were stratified into 2 cohorts according to their use of SGLT2 inhibitors at index ablation.

Of the participants with a history of type 2 DM who had received AF ablation, 10,974 were not receiving an SGLT2 inhibitor and 2366 were receiving an SGLT2 inhibitor. After propensity score matching, 2225 patients were in each group (mean age, 65±9 years; 82% White). In the non-SGLT2 inhibitor group, 26% of participants were women vs 25% in the SGLT2 inhibitor group.

The main composite outcome after the index AF ablation occurred in 619 patients in the SGLT2 inhibitor group vs 802 patients in the non-SGLT2 inhibitor group (adjusted odds ratio OR [aOR], 0.68; 95% CI, 0.602-0.776) after the 3-month blanking period. The likelihood of event-free survival at 12 months (66% vs 61%; P = .003; hazard ratio, 0.85; 95% CI, 0.77-0.95) was increased for the SGLT2 inhibitor group.

Patients in the SGLT2 inhibitor cohort had lower rates of cardioversion (aOR, 0.62; 95% CI, 0.49-0.80; P <.0001), new class I or III AAD use (aOR, 0.72; 95% CI, 0.63-0.82; P <.0001), and re-do ablations for AF (aOR, 0.71; 95% CI, 0.53-0.95; P =.022) 3 months after the index ablation. HF exacerbations (aOR, 0.81; 95% CI, 0.71-0.91; P =.001) and all-cause hospitalizations (aOR, 0.78; 95% CI, 0.68-0.91; P =.001) also were lower among patients who received SGLT2 inhibitors.

Patients on SGLT2 inhibitors had a lower all-cause mortality (aOR, 0.62; 95% CI, 0.41-0.93; P =.019).

Limitations of the study include residual unmeasured confounding in the observational study with use of retrospective data. In addition, an accurate incidence of recurrent AF after ablation may not have been obtained, because patients may have had recurrent AF after ablation but were not treated with cardioversion, AAD, or re-do ablation. Furthermore, social determinants of health and other unmeasurable confounding factors may have affected outcomes.

“…this retrospective analysis suggests that the use of SGLT2-Is [inhibitors] in patients with type 2 DM undergoing AF ablation is associated with a lower risk of needing subsequent cardioversion, new AAD therapy, and re-do AF ablation,” wrote the investigators. “This suggests that SGLT2-Is may increase the likelihood of maintaining sinus rhythm after AF ablation in patients with type 2 DM and AF.”

Disclosure: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The device is intended to provide cognitive behavioral therapy (CBT), as an adjunct to standard of care, to patients aged 18 years and older with type 2 diabetes under the care of a health care provider. Prescribed in 90-day increments, the digital therapeutic delivers CBT through a mobile application in a weekly, step-by-step process to help patients improve glycemic control.

The Food and Drug Administration (FDA) approved AspyreRx in July 2023 based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT04886388) that included 669 patients with type 2 diabetes. Patients were randomly assigned to receive AspyreRx or a control app, in addition to standard of care. 

Study findings showed use of AspyreRX led to statistically significant reductions in HbA1c at 90 and 180 days vs control. Patients in the AspyreRx group also achieved statistically significant improvements in blood pressure, weight, fasting glucose, mood, and quality of life. They also used less medication and had fewer adverse events compared with those in the control group. 

“With the launch of AspyreRx, providers now have a clinically proven treatment delivered in an easily accessible, engaging and affordable way,” said Frank Karbe, Chief Executive Officer of Better Therapeutics. “Behavior modification can be powerful medicine that is valuable at any stage of the disease and since it is already included in current treatment guidelines, we envision AspyreRx becoming part of the standard of care for adults with T2D.”

AspyreRx is available in the Apple App and Google Play stores. Additional information for prescribers can be found here.

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High lactate levels are a stress response that has been found to predict stress in patients critically ill with sepsis. Researchers therefore investigated whether arterial lactate levels upon hospital admission in patients with COVID-19-related acute respiratory failure were predictive of negative outcomes.

The observational study enrolled patients from 2 centers in Italy who had a diagnosis of COVID-19 confirmed by real time-polymerase chain reaction testing as well as pneumonia as detected by chest X-ray, computed tomography, or lung ultrasonography. Data from arterial blood gas (ABG) analysis, including pH, lactate, pO₂, pCO₂, and FiO₂, were obtained, and lactate of at least 2.0 mmol/L was considered increased. The outcome was in-hospital mortality at 30 days.

A total of 206 patients were included. Their median age was 71 (interquartile range [IQR], 57-81) years and 34% were female.

Upon admission, 14.6% of participants had lactate levels of at least 2.0 mmol/L. Age and the ratio of arterial oxygen partial pressure to fractional inspired oxygen (pO₂/FiO₂) were independently associated with increased lactate levels.

A total of 57 patients (27.7%) had in-hospital mortality at 30 days. Death occurred in 22.3% of patients with normal lactate at admission and in 56.7% of those with increased lactate at admission. The median lactate level was 1.0 (IQR, 0.8-1.3) mmol/L among survivors at 30 days and 1.3 (IQR, 1.0-2.1) mmol/L in participants who died during their hospital stay (P <.001).

Lactate levels of at least 2 mmol/L and at least 4 mmol/L upon admission were independently associated with in-hospital mortality at 30 days in multivariate analysis (2 mmol/L: hazard ratio [HR], 2.53; 95% CI, 1.29-4.95; P =.0066; 4 mmol/L: HR, 8.10; 95% CI, 1.88-34.87; P =.0050). This association also occurred for pO₂/FiO₂ <100, chronic obstructive pulmonary disease, and age. An increase in lactate levels at 24 hours was not associated with death (HR, 1.37; 95% CI, 0.42-4.49; P =.6045).

The area under the curve for lactate levels upon admission for predicting 30-day in-hospital death was 0.69 (95% CI, 0.61-0.77).

The association between lactate levels of at least 2 mmol/L and at least 4 mmol/L upon admission and 30-day in-hospital mortality was confirmed in patients with a pO₂/FiO₂ ratio of 300 mmHg or less and in those with pCO₂ of 45 mmHg or less upon admission.

Study limitations include the retrospective design and low proportion of patients with a second assessment at 24 hours. Also, cutoff values for lactate levels of 2 and 4 mmol/L were based on previous studies and guidelines in patients with sepsis.

“In our study of non-ICU patients, hyperlactatemia at admission was independently associated with in-hospital death at 30 days. Moreover, increased lactate levels were associated with the severity of respiratory failure as defined according to different

respiratory indexes,” said the study authors.

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The warning comes following the death of a preterm infant who was administered Evivo with MCT Oil, a probiotic formulated with live bacterium Bifidobacterium longum subsp. infantis, as part of in-hospital care. Genomic sequencing data confirmed that the bacterium that caused sepsis in the child was a genetic match to the bacteria contained in the probiotic.

Though the FDA is aware that some unlicensed probiotics are being used to treat infants, these products have not been evaluated for safety or effectiveness in this vulnerable population. Administering products with live bacteria or yeast to preterm infants can result in potentially fatal disease. According to a clinical report published by the American Academy of Pediatrics, “current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than 1000g.”

Health care providers who administer probiotics containing live bacteria or yeast as a treatment are required to submit an Investigational New Drug Application to the FDA. Adverse events should also be reported to the FDA’s MedWatch Program.

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The retrospective cohort study examined the effect of SARS-CoV-2 infection and COVID-19 vaccination on newly diagnosed ADs with use of electronic medical records from the Hong Kong Hospital Authority.

The cohort was classified into a COVID-19 group and non-COVID group based on diagnostic COVID-19 test results from April 1, 2020, to November 15, 2022. COVID-19 diagnosis was confirmed by positive polymerase chain reaction or positive rapid antigen test.

Adults with full COVID-19 vaccination (≥2 doses) were compared with partially/nonvaccinated individuals (1/0 dose). All participants were followed up from the study index date until death, the occurrence of incident ADs, or study end date, whichever occurred first. Outcomes were incident ADs diagnosed in inpatient and outpatient settings.

The analysis included 1,028,721 patients with COVID-19 (mean age, 52.68 years; 55% female) and 3,168,467 control individuals without COVID-19 (mean age, 54.09 years; 56% female). Crude incidence rates for ADs varied widely: incidence rates for other (ie, non-rheumatoid) autoimmune arthritis were 19.83 in the COVID-19 group vs 14.92 in the control group per 10,000-person years; for alopecia areata, incidence rates were 0.02 in the COVID-19 group vs 0.05 in the control group per 10,000-person years.

Researchers found that individuals with COVID-19 infection vs those without had a higher risk for the following new-onset ADs:

• pernicious anemia (adjusted hazard ratio [aHR], 1.72; 95% CI, 1.12-2.64);
• spondyloarthritis (aHR, 1.32; 95% CI, 1.03-1.69);
• rheumatoid arthritis (aHR, 1.29; 95% CI, 1.09-1.54);
• other autoimmune arthritis (aHR, 1.43; 95% CI, 1.33-1.54);
• psoriasis (aHR, 1.42; 95% CI, 1.13-1.78);
• pemphigoid (aHR, 2.39; 95% CI, 1.83-3.11);
• Graves’ disease (aHR, 1.30; 95% CI, 1.10-1.54);
• anti-phospholipid antibody syndrome (aHR, 2.12; 95% CI, 1.47-3.05);
• immune-mediated thrombocytopenia (aHR, 2.1; 95% CI, 1.82-2.43);
• multiple sclerosis (aHR, 2.66; 95% CI, 1.17-6.05); and
• vasculitis (aHR, 1.46; 95% CI, 1.04-2.04).

COVID-19-vaccinated patients had a decreased risk for other autoimmune arthritis (aHR, 0.74; 95% CI, 0.65-0.84), pemphigoid (aHR, 0.45; 95% CI, 0.29-0.70), immune-mediated thrombocytopenia (aHR, 0.41; 95% CI, 0.33-0.52), Graves’ disease (aHR, 0.58; 95% CI, 0.43-0.77), anti-phospholipid antibody syndrome (aHR, 0.55; 95% CI, 0.31-0.99), and systemic lupus erythematosus (SLE) (aHR, 0.29; 95% CI, 0.18-0.47) vs COVID-unvaccinated patients.

Limitations include the potential for under-reporting of COVID-19 cases and limited generalizability of the findings (ie, to autoimmune-naïve individuals only). Also, only a selected subset of autoimmune diseases was included, and socio-economic confounders such as income, access to health care, and education were not evaluated.

“Physicians should be aware of the possible connections between SARS-CoV-2 and autoimmune manifestations to optimize disease management procedures, early detection, and intervention in light of the ongoing pandemic,” stated the investigators. “Future studies investigating pathology and mechanisms would be valuable to interpreting our findings.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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“The optimal time of the day to engage in MVPA for weight management is controversial,” wrote Tongyu Ma, lead author of the study. To study the timing of exercise, researchers examined data from 5285 participants of the National Health and Nutrition Examination Survey (NHANES), which included their exercise, eating, and lifestyle habits.

The daily exercise habits were broken into 3 categories: morning (n=642), midday (2456), and evening (2187). Among those who met the physical activity guidelines (≥ 150 minutes), the adjusted means for body BMI (kg/m²) were 25.9 (95% CI, 25.2–26.6), 27.6 (95% CI, 27.1–28.1), and 27.2 (95% CI, 26.8–27.7) in the morning, midday, and evening groups, respectively. Measurement of waist circumference (cm) were also lower in the morning exercise group: 91.5 (95% CI: 89.4–93.6), 95.8 (95% CI: 94.7–96.9), and 95.0 (95% CI: 93.9–96.1), respectively.

The researchers found that “people who did moderate to vigorous exercise in the morning had a lower BMI than people who exercised at midday or in the evening.” Overall, participants in the morning cluster were older (age 59.9, 49.9, 46.1, respectively) and female (57.8%, 47.3%, 45.4%, respectively). Self-reported dietary recall found that people in the morning group had a healthier diet and less daily energy intake per unit of body weight compared with the other two groups. Interestingly, the wearable accelerometry data “showed that participants in the morning cluster accumulated less physical activity but more sedentary behavior than did those in the midday and evening clusters.”

“Our findings substantiated the role of morning MVPA in weight management. However, owing to the observational nature of our data, it remains inconclusive whether morning MVPA is more effective than evening MVPA in reducing obesity,” the authors said. However, the current analysis seems to be supported by earlier studies. In a study by Willis et al,² they “found a greater reduction in body mass and fat mass among participants who attended more than 50% of their training sessions in the morning compared with those who attended more than 50% of their training sessions between [3:00 PM and 7:00 PM].” Another study by Creasy et al,³ “found that a high amount of MVPA in the morning was a key feature of the physical activity pattern among successful weight loss maintainers, further supporting the important role of morning MVPA in weight management.”

Another interesting finding of the study is that “participants in the morning cluster spent a significantly higher amount of time on sedentary behavior than participants in the other clusters. However, despite the longer duration of sedentary time and the statistical adjustment for sedentary time, the favorable BMI and WC outcomes in the morning cluster persisted,” the authors wrote.

This study has limitations. The cross-sectional design of the study does not demonstrate temporal precedence. “Therefore, the causal relationship between the diurnal pattern of MVPA and obesity cannot be established. It is possible that the differences in BMI and WC cause the diurnal pattern of MVPA rather than the diurnal pattern causes changes of BMI and WC,” the authors report.

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No reviews comparing temporal patterns of heart, brain, and blood vessel damage following hypertensive disorders of pregnancy have been found. Therefore, investigators sought to characterize heart, brain, and blood vessel damage due to hypertensive pregnancy from pregnancy through early and late postpartum periods, comparing changes that occur with variations in blood pressure. Cardiac changes were the primary outcome. Vascular changes, renal, and neural changes were secondary outcomes.

The investigators conducted a systematic review searching the EMBASE, Ovid/MEDLINE, and ClinicalTrials.gov databases from 2000 through February 2023 for articles in English concerning pregnancies and reporting on blood pressure trajectories or target organ damage during or after a hypertensive pregnancy. Primary research studies, trend studies, panel designs, cohort studies, and time-series designs were included. Abstracts, guidelines, reviews, and conference posters were excluded.

Articles were evaluated without meta-analysis (due to heterogeneity) using a vote-counting approach (comparing the number of positive studies with the number of negative studies) regardless of statistical significance. The investigators defined target organ damage as negative alterations affecting the function and structure of organ systems.

The investigators included 76 studies (over 1.7 million pregnancies) reporting on target organ damage or blood pressure trajectories during or after hypertensive pregnancy and found that, during hypertensive pregnancy, proteinuria and retinal microvasculature changes, white matter lesions, and left ventricular hypertrophy were first evident. Overall, during pregnancy and delivery, 7 studies reported systolic or diastolic dysfunction and 7 studies reported increased left ventricular remodeling. Temporally, 3 studies reported systolic or diastolic dysfunction and 4 studies reported increased left ventricular remodeling up to 1 year postpartum.

More than a decade postpartum, 1 study reported systolic or diastolic dysfunction and 2 studies reported increased left ventricular remodeling.

Overall, preeclampsia was the most common hypertensive disorder reported in the studies. Other disorders examined included low platelet count, elevated liver enzyme activity, gestational hypertension, and eclampsia. Risk of bias showed 18% of the studies with low risk and 82% of the included studies with moderate risk of bias according to the Newcastle-Ottawa scale.

Despite blood pressure reduction early in postpartum, retinal, cerebral, and cardiac changes were noted during early and late postpartum periods. The late postpartum period was the initial time cognitive dysfunction was reported.

Limitations of the study include a lack of meta-analysis narrowing conclusions that can be drawn, and the observational nature of the included studies prevents cause-and-effect inferences.

“The majority of target organ damage reported during a hypertensive pregnancy remains evident throughout the early and late postpartum period despite variation in blood pressure,” the investigators wrote. “Early peri-partum strategies may be required to prevent or reverse target organ damage in women who have had a hypertensive pregnancy.”

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To better understand the association between obesity-related biomarkers and cardiovascular dysfunction in HFpEF, researchers at Massachusetts General Hospital conducted a retrospective cohort study of participants with preserved ejection fraction and chronic dyspnea who underwent cardiopulmonary exercise tests from 2006 to 2017.

A history and physical examination, including overnight fasting phlebotomy at the time of exercise tests, were conducted for each participant. Obesity was defined as a body mass index (BMI) greater than 30 kg/m². From blood samples, the researchers measured high-sensitivity C-reactive protein (CRP), adiponectin, interleukin-6, leptin (IL-6), resistin, and insulin resistance (HOMA-IR).

Participants underwent right heart catheterization prior to exercise testing. Hemodynamic parameters were obtained at rest and during exercise. Overall exercise capacity was measured by peak oxygen consumption (VO₂). The researchers defined HFpEF on the basis of elevated left ventricular filling pressures at rest or during exercise.

The association between obesity-related biomarkers and exercise parameters was evaluated with multivariable linear regression. The researchers used Cox proportional hazard analyses to assess the association between the biomarkers and clinical outcomes. 

The study included 509 participants, of whom 228 (49%) met the clinical criteria for HFpEF. Compared with participants without HFpEF, those with HFpEF were more likely to have obesity, hypertension, and diabetes. Participants with HFpEF were also more likely to have higher baseline levels of CRP, IL-6, HOMA-IR, and leptin in addition to lower VO₂. 

The researchers found that obesity-related biomarkers were associated with overall exercise capacity (P ≤.002 for all). Higher biomarker levels were associated with worse fitness, although higher levels of adiponectin were associated with better peak VO₂. The largest effect size was seen with leptin (β, -2.35; SD, 0.19; P <.001). 

CRP, IL-6, and resistin were associated with chronotropic response (P ≤.001 for all), whereas worse HOMA-IR, lower adiponectin, and higher leptin levels were associated with greater blood pressure response (P ≤.002 for all). 

In secondary analyses, increased risk for HFpEF was significantly associated with:

• Obesity (odds ratio [OR], 1.96; 95% CI, 1.30–2.96);
• Diabetes (OR, 1.89; 95% CI, 1.04–3.41);
• Higher leptin levels (OR, 1.35; 95% CI, 1.09-1.70); and,
• Higher CRP levels (OR, 1.25; 95% CI, 1.03-1.52).

Study limitations include a lack of generalizability due to potential referral bias, the potential of confounding comorbid conditions, limited power to examine the association between the explored biomarkers and a purely obese-HFpEF phenotype, and limited associations with clinical outcomes due to sample sizes. 

The researchers concluded, “[S]pecific obesity-related pathways including inflammation, adipokine signaling, and insulin resistance may underlie the association of obesity with HFpEF and exercise intolerance.” 

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The recall includes cough and cold products, pain relievers, and medications to relieve constipation and diarrhea, among others. The full list of affected products can be found here. The items were sold in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.

At this time, there have been no reports of adverse events associated with the recalled products. According to the Company, the recall is being conducted out of an abundance of caution. 

Individuals with questions related to this recall can contact Family Dollar customer service at 844-636-7687. Adverse events and quality issues should be reported to the Food and Drug Administration’s MedWatch program.

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Researchers conducted parallel cohort studies using data from the UK (January 1998 to January 2020) and Ontario, Canada (April 2002 to September 2020). They sought to estimate the association between different patterns of oral corticosteroid prescribing and appropriate fracture prevention care among older adults with high cumulative exposure to oral corticosteroids due to relapsing-remitting conditions, such as eczema, asthma, and chronic obstructive pulmonary disease (COPD).

The UK study used deidentified primary care data from Clinical Practice Research Datalink GOLD, and the Ontario study used population-based primary and secondary care administrative data from ICES (previously Institute for Clinical Evaluative Sciences). The researchers evaluated data on patients with eczema, asthma, or COPD aged 66 years and older who exceeded the cumulative oral corticosteroid high-risk dose threshold of 450 mg of the prednisolone-equivalent dose within the previous 6 months. The analysis included 65,195 patients from the UK study (mean age, 75 [interquartile range {IQR}, 71-81] years; 50.6% men), and 28,674 patients from the Ontario study (mean age, 73 [IQR, 69-79] years; 59.5% men).

For the primary exposure, the researchers classified patients as either having low-intensity (90 days or longer to cross the risk threshold) or high-intensity (fewer than 90 days to cross the risk threshold) oral corticosteroid prescriptions. The primary outcome was prescriptions for fracture-prevention medications, which are recommended in guidelines for this population and include bisphosphonates, bazedoxifene, burosumab, raloxifene, and teriparatide.

In the UK study, 1 year after the index date, 8.9% of patients who had reached the risk threshold of a 450-mg prednisolone-equivalent dose had received fracture prevention care medication, with 10.7% receiving high-intensity oral corticosteroid prescriptions and 4.8% receiving low-intensity prescriptions (crude rates, 134 vs 57 per 1000 person-years; crude hazard ratio [HR], 2.34; 95% CI, 2.19-2.51; adjusted HR, 2.13; 95% CI, 1.99-2.29).

In the Ontario study, at 1 year after the index date, 6.1% of patients who had reached the risk threshold of a 450-mg prednisolone-equivalent dose had received fracture prevention care, with 6.4% receiving high-intensity oral corticosteroid prescriptions and 4.4% receiving low-intensity prescriptions (crude rates, 73 vs 48 per 1000 person-years, respectively; crude HR, 1.49; 95% CI, 1.29-1.72; adjusted HR, 1.47; 95% CI, 1.27-1.70).

In analyses with disease subgroups that compared patients with high-intensity vs low-intensity oral corticosteroid prescriptions, the highest HRs for being prescribed fracture prevention care were in patients with COPD (HR, 1.58; 95% CI, 1.30-1.91) and those with asthma (HR, 1.42; 95% CI, 1.07-1.88). No substantially increased risk was observed for patients with eczema (HR, 1.15; 95% CI, 0.89-1.50).

At the end of the UK study, 5.1% of patients who had reached the risk threshold with high-intensity oral corticosteroid prescriptions had experienced a major osteoporotic fracture, vs 4.7% with low-intensity prescriptions (crude rates, 14 vs 13 per 1000 person-years; crude HR, 1.07; 95% CI, 0.98-1.15; adjusted HR, 1.12; 95% CI, 1.03-1.21).

At the end of the Ontario study, 10.3% of patients who had reached the risk threshold with high-intensity oral corticosteroid prescriptions had experienced a major osteoporotic fracture, vs 10.1% with low-intensity prescriptions (crude rates, 20 vs 23 per 1000 person-years; crude HR, 0.87; 95% CI, 0.79-0.96; adjusted HR, 0.91; 95% CI, 0.73-1.12).

Among several limitations, the study lacked data regarding medication adherence. The UK study only included information about whether the prescription was written, and the Ontario study only included information about whether the prescription was filled. Additionally, other unmeasured confounders such as frailty may account for the association between oral corticosteroid prescribing patterns, receiving fracture prevention care, and experiencing fractures.

The researchers concluded, “These findings suggest missed opportunities to initiate fracture prevention for older people prescribed oral corticosteroids.” They added, “Clinicians, including dermatologists, respirologists, general practitioners, and internists, should be aware of recent cumulative oral corticosteroid dose, regardless of the prescribing pattern, and initiate fracture preventive care if indicated.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Between December 2021 and June 2022, researchers conducted a multicenter cross-sectional study and the relationship between IA, emotional intelligence (EI), and sociodemographic traits in Spanish undergraduate nursing students aged 18 to 24 years. The researchers gathered sociodemographic data through participant questionnaires and utilized the Internet Addiction Test (IAT) scale and Trait Meta-Mood (TMMS-24) scale to measure IA and EA, respectively. Students qualified for IA if they scored 40 and greater on the IAT. For EI, students were assessed across three dimensions: attention, emotional repair, and emotional clarity.

A total of 532 nursing students from 2 universities and 3 campuses were included in the final analysis and the majority were women (n=453; 85.2%). Overall, 11.1% (n=59) of participants qualified for internet addiction. This cohort of students with IA displayed significantly higher levels of attention (median=31; P =.010; Cohen d = -0.375) than the other students (median=28). However, internet addiction was also associated with significantly lower levels of emotional clarity (median=22; P =.031; Cohen d =0.307) than controls (median=24).

Noteworthy gender differences were observed across participants, regardless of IA status. Overall, women displayed higher attention scores (median=28; P =.033) than men (median=27), while men exhibited higher emotional repair scores (median=26; P =.048) than women (median=24).

Furthermore, significant age-related differences were detected using the Kruskal-Wallis H test. Age groups significantly differed regarding their IA (P <.001), with younger students aged 18 (median=28) and 19 (median=27) years displaying the highest addiction scores. Age groups also had significantly different scores across emotional clarity (P =.024) and emotional repair (P =.047), with students aged 24 years and older displaying the highest scores (clarity: median=26; repair: median=27), compared to all the younger age groups.

The researchers also assessed the relationship between IA scores and the EI dimensions using Spearman correlations. Emotional clarity (Rho= -0.169; P <.01) and emotional repair (Rho= -0.095; P <.05) were both significantly, but weakly, correlated to IA values.

The authors concluded, “The development of programs which improve emotional intelligence could be essential to facilitate the emotional management of internet addiction.”

This study was limited by the use of a cross-sectional design, as it did not allow for the determination of causal relationships.

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Patients with FEDs often have a high rate of comorbidity with other psychiatric and medical issues, suggesting the need for a multidisciplinary approach to treatment. Among these therapeutic approaches, educational interventions have gained increased attention for the specific and concrete strategies that provide skills to patients in managing their disorder. With this in mind, the review authors aimed to assess the effect of educational interventions on adolescents with FEDs.

The review authors conducted this systematic review by searching the databases of Scopus, Cochrane Library, ENFISPO, DIALNET, CUIDEN, PsycINFO, CINAHL, and PubMed through June 2023 for articles in English or Spanish related to educational interventions in a young population diagnosed with anorexia nervosa, avoidant/restrictive food intake disorder, bulimia nervosa, pica and ruminative disorders, and binge-eating disorder. Additionally, reviewers searched grey literature on OpenGrey and Teseo.

Included studies were of quasi-experimental or experimental design that assessed the efficacy of educational interventions in patients with FEDs, aged 12 to 18 years. Studies with anorexia as a symptom (defined as lack of appetite or appetite affected by multiple causes) due to underlying disease were excluded, along with publications in which interventions were directed exclusively at families or support groups. These criteria yielded 10 publications that evaluated the impact of a variety of learning techniques and educational interventions on FEDs in a total of 517 participants.

The studies evaluated in the review measured the effects of educational interventions on learning, improved nutritional knowledge, and positive mental changes toward food/eating. In 4 studies, educational intervention was associated with weight gain in patients and some studies reported decreases in the frequency of vomiting, binge-eating, and purging. Results across studies also show a general trend of more normalized eating patterns following intervention. Furthermore, educational intervention was associated with increased cognitive flexibility in 1 comparative study.

However, the studies included had a wide variability in educational methodologies and assessed outcomes using different tools, making current review comparisons difficult. Risk of bias was also high due to the low methodological quality found in these articles. A small sample size was cited in 6 studies and the vast majority of articles (n=9) only examined FEDs in girls. The heterogeneity in outcome evaluation, groups vs individual settings, and the interventions themselves limit the ability to make clinical recommendations as to therapeutic impact.

Though the authors indicated that educational interventions seem to improve patient knowledge and have a positive effect on health outcomes, the incongruous study elements necessitate further research to robustly support this therapy. The reviewers concluded, “Only by obtaining a deeper understanding, can we generalize our results beyond current studies and provide constructive information for the design of educational programs aimed at this population.”

This review was limited by the inclusion of studies with varying methodological quality and evidence levels, as this significant heterogeneity did not allow for meta-analysis.

The post Adolescents With Eating Disorders May Benefit From Educational Interventions appeared first on The Cardiology Advisor.

Investigators aimed to characterize the cross-sectional and across time-relationship between patients’ health status and activity measured by a wearable smartwatch device.

The investigators used data from the CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure; ClinicalTrials.gov Identifier: NCT04252287) study. Briefly, CHIEF-HF was a randomized, controlled trial conducted from the end of March 2020 to mid-February 2021 from 18 medical centers across the US. Participants with HF completed the serial Kansas City Cardiomyopathy Questionnaires (KCCQs) and functional performance was assessed using a wearable device to test the efficacy of canagliflozin on health status.

In the current analysis, the investigators included data from 425 patients with HF (mean [SD] age, 63.5 [13.2] years; 44.5% women; 40.9% with reduced ejection fraction) and a compatible smartphone. Patients were excluded for a variety of reasons including history of diabetic ketoacidosis, type 1 diabetes, hypotension, and acute decompensated HF. Participants (83% White; 15% Black; 27.5% type 2 diabetes) completed the KCCQs through a smartphone application and were provided a Fitbit Versa 2.

Mean KCCQ-total symptom (TS) scores increased 2.5 points on average through 12 weeks and the KCCQ-physical limitation (PL) scores increased by 4.0 points through 12 weeks.

Baseline daily step count increased across the KCCQ-TS categories of scores:

• 2438 steps/d for scores of 0 to 24
• 4004 steps/d for scores of 25 to 49
• 4260 steps/d for scores of 50 to 74
• 4871 steps/d for scores 75 to 100; P <.001

Scores similarly increased across the KCCQ-PL categories of scores (2302 steps/d for scores of 0 to 24; 5351 steps/d for scores 75 to 100; P <.001). After multivariable adjustment, this relationship remained significant for KCCQ-TS and KCCQ-PL scores.

Changes in daily step count were significantly associated with nonlinear changes in KCCQ-TS scores (P =.004) and with nonlinear changes in KCCQ-PL scores (P =.003). This nonlinear association was primarily seen with daily step counts of less than 5000 steps. Little association was found between KCCQ scores and step counts greater than 5000 steps/d.

The investigators stated that daily floors climbed was not significantly different across 25-point ranges of KCCQ-TS scores or KCCQ-PL scores, and floors climbed was associated with baseline KCCQ scores alone.

Significant study limitations include commercially available wearable devices may not be optimal for measuring functional performance in patients with HF. There is also lack of data on comorbidities and the inability to quantify external factors (ie inclement weather’s affect on step count).

“Daily step count was nonlinearly associated with health status at baseline and over time in patients with heart failure,” the investigators wrote.

Disclosure: This research (CHIEF-HF) was supported by Janssen Research & Development, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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With the legalization and normalization of recreational and medical marijuana, use is increasing across all age groups, however, research has focused solely on men and younger adults. Until now, there has been little research on the prevalence of cannabis use among women in perimenopause and postmenopause.

Data taken from 5000 women analyzed the frequency, forms, and motives of cannabis use by postmenopausal women. Results indicated that cannabis use is common in women in this stage of life. More than 40% of participants reported using cannabis for recreational or therapeutic purposes, most often to treat chronic pain (28%), anxiety (24%), sleep problems (22%), and stress (22%). Six percent of women reported using cannabis for menopause symptoms, specifically mood and sleep difficulties.

“We know that cannabis products are being marketed to women to manage menopause symptoms, and these findings suggest that midlife women are turning to cannabis for menopause symptoms and other common issues in the menopause transition,” said Carolyn Gibson, PhD, lead author of the study and health services researcher at the University of California, San Francisco. “We still do not know if use is actually helping for those symptoms, or if it may be contributing to other challenges,” she said in a press release.

According to the study, over the past 30 days, more than 10% of participants reported using cannabis: 56% via smoking, 52% consumed edible products, and 39% used more than one form of cannabis. Of the participants who reported past 30-day use, 31% reported smoking cannabis on a daily or near-daily basis, while 19% reported daily or near-daily use of edible cannabis products.

Stephanie Faubion, MD, medical director for The Menopause Society said that the study findings suggest the “need for recognizing and discussing cannabis use in the health care setting.” She concluded that additional research is needed to determine the harms of benefits of using cannabis.

The post Can Cannabis Use Help Manage Menopause Symptoms? appeared first on The Cardiology Advisor.

In the multinational Analyzing Data, Recognizing Excellence and Optimizing Outcomes (ARO) ii study, investigators compared outcomes between 713 analog insulin and 733 human insulin users. In adjusted multivariable analyses, significantly lower proportions of the analog than human insulin group experienced major adverse cardiovascular events (MACE, 26.8% vs 35.9%), hospitalization (58.2% vs 75.0%), and all-cause mortality (22.0% vs 31.4%), James Fotheringham, PhD, of the University of Sheffield in Sheffield, UK, and colleagues reported in the American Journal of Kidney Diseases. Analog users had significant 18.3%, 24.3%, 19.2% lower risks for these outcomes, respectively. MACE was defined as hospitalization for coronary, cerebral, or peripheral arterial events, heart failure, or cardiac arrest.

Hypoglycemia (less than 3.0 mmol/L) occurred at comparable rates among analog and human insulin users: 14.1% vs 15.0%.

Insulin therapy is the “cornerstone” of antihyperglycemic treatment in kidney failure since these patients are ineligible for sodium-glucose contransporter 2 inhibitors, Dr Fotheringham’s team noted.

“Both long- and short-acting analogues, therefore, could significantly reduce glycemic variability, which has been linked to mortality in people on HD, without necessarily modifying HbA1c.”

Human insulin, they noted, has been linked with postprandial hyperglycemia followed by hypoglycemia and weight gain.

Since this was an observational study, residual confounding could not be ruled out, such as the cost and availability of each insulin type.

Disclosure: This research was supported by Amgen. Please see the original reference for a full list of disclosures.

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This study is the first to assess the relationship of corneal sensation and DR severity with robust representation of individuals with Hispanic ethnicity, who are frequently underrepresented in clinical trials for DR treatment. The researchers add that corneal sensitivity impairment can factor into the development of complications such as neurotrophic keratopathy (NK) and potential vision loss.

Fifty consecutive adult patients (aged mean 57.9 years; 66% Hispanic; 25 men) from a retinal practice who had diabetes mellitus type 1 or 2 and DR were included in the study. Patients underwent eye exams, which included an assessment of corneal sensitivity with a Cochet-Bonnet esthesiometer. The investigators compared eyes’ corneal sensitivity (65 no history of PDR 35 current or regressed PDR) with the Mann-Whitney U test and tested the effect of prior anti-VEGF therapy on corneal sensitivity.

At baseline, 26 eyes had PDR while 74 had NPDR. Nine of the NPDR eyes had regressed from PDR to NPDR, including 7 that regressed after anti-VEGF therapy. Eyes with history of PDR had shorter median corneal sensitivity compared with eyes of patients without PDR history (0.5 cm vs 4.75 cm).

Eyes that had regressed from having PDR to NPDR and eyes with untreated PDR had lower median corneal sensitivity compared with eyes with no PDR history (0 cm vs 0 cm vs 4.5 cm P =.0076). Compared with eyes with NPDR, eyes were 3.6 times more likely to have complete corneal sensitivity loss and 90% more likely to have corneal sensitivity of no more than 4 cm in at least 2 quadrants if they had PDR.

“In the context of previous studies, which describe a higher risk of worse outcomes for both DR and NK among diabetic patients from underrepresented backgrounds, it stands to reason that clinical practice could benefit from improved collaboration between primary care, cornea specialists, and retina specialists,” the study authors suggest. “While therapy with anti-VEGF medications can promote vascular regression of PDR, this improvement in DR is not accompanied by recovery of neural corneal sensitivity.”

They said doctors might consider assessing corneal sensitivity when evaluating diabetic eye disease as early detection is essential and DK frequently occurs in patients with diabetes.

Limitations of the study include cross-sectional nature of the data and underrepresentation of eyes with regression from PDR to NPDR.

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies, and Oyster Point Pharma provided funding for the research. Please see the original reference for a full list of authors’ disclosures. 

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Neurodegenerative diseases affect millions of people worldwide and since older age contributes to this risk, they are becoming more prevalent as life expectancy increases.¹ The two most common neurodegenerative diseases are Parkinson Disease and Alzheimer disease.¹ Diagnosing neurodegenerative disease is difficult due to overlapping symptomatology, especially in the early stages of disease. To aid in diagnosis, functional brain imaging or invasive tests like lumbar puncture are often required.² The latest research is focused on identifying biomarkers in bodily fluids like cerebral spinal fluid (CSF) and blood. However, collecting CSF is a highly invasive procedure, and blood composition is not only complex, but has reduced CNS-derived biomarkers due to the blood brain barrier.³ Tear collection, however, may provide clinicians with a less invasive strategy for obtaining proteomic biomarkers. With their ease in collection and close relation to the CNS, tears may be the new frontier.⁴

Alzheimer Disease

Alzheimer disease is the most common cause of dementia in adults and the fifth leading cause of death in Americans aged 65 years and older.⁵ This neurodegenerative disease is caused by an abnormal buildup of protein in the brain cells. Amyloid-beta and tau are 2 such proteins responsible for building plaques around the cells and forming tangles within the cells, respectively. The most common sign of Alzheimer Disease in its early stage is life-disrupting memory loss. Visual symptoms can include trouble with depth perception, tracking, and contrast sensitivity. 

Ancillary Testing for Alzheimer Disease

OCT and OCT-A have been a focal point of research for early biomarker detection of Alzheimer Disease. A 2019 investigation that used spectral domain-OCT revealed thinning of the ganglion cell inner plexiform layer (GCIPL), ganglion cell complex (GCC), peripapillary retinal nerve fiber layer (RNFL), and choroid among individuals with Alzheimer disease compared with individuals who did not have the disease.⁶ Another investigation using OCT-A showed lower whole and parafoveal vessel densities in patients with Alzheimer disease compared with control group participants without the disorder.⁷

Tear Biomarkers for Alzheimer Disease 

Although this technology may lead clinicians to suspect Alzheimer disease during an earlier stage, the disease can only be definitively diagnosed postmortem. While imaging devices can provide a method of noninvasively obtaining potential neurodegenerative disease biomarkers, the ocular surface may also be a source of easy-to-access biomarkers for early disease. Amyloid precursor protein, and the peptides it releases upon degradation, are being investigated as potential biomarkers for the disease that can be obtained through tear analysis, as these peptides may be present in the tears of individuals with Alzheimer disease.^4,8,9 A 2019 investigation found that corneal fibroblasts and corneal epithelium expressed amyloid precursor protein in patients with Alzheimer disease, highlighting the possibility that the ocular surface holds a key to identifying Alzheimer disease and its progression.¹⁰ 

These proteomic composition changes, along with decreased tear breakup time (TBUT), lower Schirmer test values and increased tear flow rate may identify patients with Alzheimer disease^.11,12 While further research is needed, these results suggest that the ocular surface may be the future of Alzheimer disease diagnosis and monitoring.

Parkinson Disease

Following Alzheimer disease, Parkinson disease is the second most common neurodegenerative disease in the United States.¹³ This disorder involves a degeneration of dopamine neurons and a buildup of alpha-synuclein proteins. This neurodegeneration leads to a clinical presentation of tremors and slow, rigid movements. Common visual symptoms include dry eye and diplopia, which clinicians can manage with dry eye therapies and prism spectacles, respectively.

Ancillary Testing for Parkinson Disease

Clinicians can observe retinal changes associated with Parkinson disease through OCT analysis. Reduced RNFL thickness and foveal changes, such as thinning and broadening of the pit, have been linked to the disorder.^14,15 The inner retinal layer — a layer containing dopaminergic amacrine cells — can also demonstrate significant thinning in Parkinson disease.¹⁶ Since dopamine is a key player in regulating certain visual processes, it makes sense that retinal changes are linked to Parkinson disease. OCT-A may reveal microvasculature changes, including superficial capillary plexus vessel density and perfusion density reductions.¹⁷ The challenge with these findings, however,  is  the lack of specificity to the disease.

Tear Biomarkers for Parkinson Disease

Parkinson disease researchers have also turned to the tears looking for disease biomarkers. Research involving patients with the disease reveals a significant reduction in corneal nerve density and the presence of alpha-synuclein in the basal tears of these individuals.^18,19,20 TBUT and Schirmer test scores are also significantly lower in patients with Parkinson disease and corneal staining and Ocular Surface Disease Index (OSDI) scores are significantly higher.^21,22 These findings likely correlate with a reduced blink rate, a common sign of Parkinson Disease due to the dysfunction of the dopaminergic pathway.²³  

Optometry’s Evolving Role in Patient Care

“Understanding neurodegenerative diseases and their markers is such an important topic right now,” according to Kelly K. Nichols, OD, MPH, PhD, FAAO, a vision researcher specializing in dry eye disease and dean of the University of Alabama at Birmingham School of Optometry. “It would be wonderful if the proteome of the tears could help with early diagnosis. At a minimum, the knowledge that dry eye signs and symptoms may occur in patients with these disorders may shed light on one more aspect of impact on quality of life that can be managed by an optometrist.”

Although research has yet to determine adequate specificity and sensitivity for these neurodegenerative disease-related biomarkers, optometrists should stay up to date on this evolving research. While it is important for clinicians to provide symptom management, eye care professionals must also incorporate testing that may support early diagnosis and monitoring of these complex diseases.

The post Tear Analysis May Reveal Neurodegenerative Disease Biomarkers appeared first on The Cardiology Advisor.

Investigators aimed to determine the efficacy and safety of nonpharmacological interventions for reducing fatigue among patients with I-RMDs.

The investigators conducted a systematic review and meta-analysis, including studies with patients aged at least 18 years diagnosed with I-RMDs who were prescribed nondrug interventions by their healthcare providers. Patients treated with placebo or usual/standard care comprised the comparator/control group.

The main study outcome was fatigue, as assessed by self-reported outcome measures.

A total of 82 studies were included in the systematic review, with 55 randomized controlled trials (RCTs) included in the meta-analysis. The majority of the included RCTs were of moderate to high quality, though 4 were of low quality. No publication bias was found.

Results of the meta-analysis revealed exercise or physical activity was effective for reducing fatigue among patients with spondyloarthritis (standardized mean difference [SMD], -0.94; 95% CI, -1.23 to -0.66; P <.001), systemic lupus erythematosus (SLE) (SMD, -0.54; 95% CI, -1.07 to -0.01; P =.04), and rheumatoid arthritis (RA) (SMD, -0.23; 95% CI, -0.37 to -0.10; P <.001), compared with standard care.

No significant reduction in fatigue was found among patients with Sjögren syndrome (SMD, -0.83; 95% CI, -2.13 to 0.47; P =.21) or systemic sclerosis (SMD, -0.66; 95% CI, -1.33 to 0.02; P =.06) when treated with exercise or physical activity vs standard care.

Psychoeducational interventions were effective for reducing fatigue among patients with RA (SMD, -0.32; 95% CI, -0.48 to -0.16; P <.001) but not among those with SLE (SMD, -0.19; 95% CI, -0.46 to 0.09; P =.18).

No significant reductions in fatigue among patients with RA were found in follow-up models assessing multicomponent interventions (physical activity or exercise + psychoeducational intervention) (SMD, -0.20; 95% CI, -0.53 to 0.14; P =.24) and consultations (SMD, -0.05; 95% CI, -0.29 to 0.20; P =.71), compared with the control group.

The investigators noted several nonpharmacological interventions not included in the meta-analysis may offer reduction of fatigue safely, including: traditional Chinese medicine, dietary modifications, balneotherapy, transcranial direct current stimulation, transcutaneous auricular vagus nerve stimulation, whole body vibration, and aromatherapy.

While the majority of studies did not report on safety of the nonpharmacological interventions, among the 31 that did, no serious or clinically significant adverse events were reported.

Study limitations included few RCTs reporting fatigue as the primary outcome, a lack of standardization and validation of fatigue measures, difficulty with blinding among the included studies, and potential clinical heterogeneity.

The study authors noted, “Safety results were reassuring. However, safety information

was often lacking in the retrieved studies and mentioning safety in detail in future non-pharmacological interventions addressing fatigue is advisable. Even if no adverse events or side effects are observed, this should be clearly reported in future studies.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers conducted a systematic review to assess the literature on cerebrovascular hemodynamics in patients with ACS and their effect on cognitive functioning.¹

A search was performed in the MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases through May 2022 for prospective case-control studies that included adults aged 18 years or older with unilateral or bilateral ACS, a control group, and a validated, objective measure of global cognitive function or 1 or more domains of cognitive function separately.

The review included 5 studies with 782 patients and 407 control individuals. Among the studies, 4 were cross-sectional and 1 provided longitudinal data for 3 years of follow-up.

All included studies used the breath-holding index to evaluate cerebrovascular reactivity, and substantial heterogeneity was observed in the use of neuropsychologic assessments to assess cognitive performance.

All 5 studies found a significant association between unilateral and/or bilateral ACS and cognitive impairment, and 4 studies reported a significant association between a reduction in cerebrovascular reserve and impaired cognitive function in patients with unilateral ACS. The participants with ACS and reduced cerebrovascular reserve had significantly decreased global and domain-specific cognitive performance, and the lowest cognitive scores occurred in patients with bilateral stenosis and cerebrovascular reserve reduction.

In the 1 longitudinal study, Balestrini et al² evaluated progressive cognitive decline in patients with unilateral ACS vs control individuals during a 3-year period. Cognitive deterioration, based on a 3-point reduction in Mini-Mental State Examination scores, occurred in 24.8% of patients with ACS (unilateral stenosis, 70%-99%) compared with 7% of age-matched control individuals. The study authors found a significant association between impaired ipsilateral cerebrovascular reserve and progressive global cognitive decline in patients with ACS vs those with preserved ipsilateral cerebrovascular reserve (P <.05).

Limitations include the small number and size of the studies, which did not allow a quantitative analysis to be performed. Also, significant heterogeneity occurred regarding the neuropsychologic tests used, and most studies did not include a standard protocol for baseline or follow-up neuroimaging evaluation. Furthermore, most of the participants were men, and most studies were cross-sectional.

“This review provides support for the use of comprehensive neurocognitive assessments and CVR [cerebrovascular reserve] assessment, in addition to longitudinal ultrasound evaluations of carotid plaque progression and/or phenotype, to facilitate risk stratification of patients with ACS,” wrote the researchers. “Clinicians may be prompted to consider cognitive impairment as a critical factor in risk stratification of ACS patients for consideration of carotid interventions.”

Disclosure: One of the study authors declared affiliations with a medical technology company. Please see the original reference for a full list of authors’ disclosures.

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The randomized, open-label, noninferiority TAVR-CMR (Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement; ClinicalTrials.gov Identifier: NCT03831087) trial was conducted at 2 heart centers in Austria and assessed the noninferiority of CMR vs CT for guiding TAVR.

Potential TAVR candidates were randomly assigned in a 1:1 fashion to have a predefined TAVR-CMR protocol or a standard contrast-enhanced TAVR-CT protocol to evaluate anatomic characteristics of the aortic annulus and access route. Eligible participants had severe aortic stenosis diagnosed based on guidelines of the European Society of Cardiology/European Association for Cardiothoracic Surgery and had typical symptoms of severe aortic stenosis.

The primary outcome was defined per the Valve Academic Research Consortium (VARC)-2 criteria as device success at discharge including absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomic location, and proper intended performance of the prosthetic heart valve.

A total of 380 potential TAVR candidates were randomly assigned to CMR-guided (191 patients) or CT-guided (189 patients) TAVR planning from September 11, 2017, to December 16, 2022. Among the cohort, 138 participants in the CMR-guided group and 129 patients in the CT-guided group had TAVR (modified intention-to-treat [mITT] population). The per-protocol cohort included 248 patients (121 in the CMR group, 127 in the CT group). The median age for both populations was 82 years, and 50% were women.

For the mITT cohort, device implantation success occurred in 93.5% of patients in the CMR group and in 90.7% of patients in the CT group (between-group difference, 2.8%; 90% CI, -2.7 to 8.2%; P <.01 for noninferiority). In the per-protocol cohort, device implantation success occurred in 92.6% of the CMR-guided patients and in 90.6% of the CT-guided patients (between-group difference, 2.0%; 90% CI, -3.8 to 7.8%; P <.01 for noninferiority).

Stroke or transient ischemic attack (TIA) and the need for permanent pacemaker implantation occurred more frequently in the CT-guided group (stroke/TIA: 5.4% vs 0.7%; P =.02 in the mITT population; 5.5% vs 0.8%; P =.04 in the per-protocol population; permanent pacemaker: 11.6% vs 3.6%; P =.01; 11.8% vs 3.3%; P =.01, respectively).

The CMR and CT groups had comparable all-cause mortality at a median of 6 months (8.7% vs 7.0%, respectively; P =.60 in the mITT population; 8.3% vs 7.1%, respectively; P =.73 in the per-protocol population).

Sensitivity analyses with use of VARC-3 device success criteria were consistent with the primary outcome (mITT: 88.4% vs 85.3%; P =.01 for noninferiority; per-protocol: 90.1% vs 85.0%; P <.01 for noninferiority).

Among several limitations, the prespecified noninferiority margin of 9% absolute risk difference is liberal for an expected failure rate of 8%, the investigators noted. Also, the use of an alpha of 0.10 instead of 0.05 for nominal significance is different from convention. Other limitations included the open-label design, and contrast volume was not systematically evaluated.

“…CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success at hospital discharge, with no difference between the groups in the proportion undergoing the TAVR procedure,” the study authors wrote.

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Taurolidine is an antibacterial and antifungal agent with a mechanism of action that is less prone to development of antimicrobial resistance, Anil K. Agarwal, MD, of the University of California, San Francisco, and colleagues explained. Heparin does not have any antimicrobial properties, but it helps prevent thrombosis.

In the double-blind, phase 3 LOCK IT-100 trial (ClinicalTrials.gov Identifier: NCT02651428), the investigators randomly assigned 397 patients from 70 US sites to taurolidine (13.5 mg/mL) with heparin (1000 units/mL) and 398 patients to heparin only instilled into central venous catheters after dialysis sessions.

CRBSIs occurred in 9 patients (2%) in the taurolidine/heparin group compared with 32 patients (8%) in the standard of care heparin group. Infection events occurred in 0.13 vs 0.46 per 1000 catheter-days, respectively. Patients receiving taurolidine/heparin had a significant 71% reduced risk for CRBSIs, the investigators reported in the Clinical Journal of the American Society of Nephrology.

Rates of catheter removal (for any reason) and loss of catheter patency were comparable between groups.

Treatment-emergent adverse events occurred in 79% of both groups, and most were considered mild to moderate in severity. The death rate was 5% for both groups.

“These findings support the use of taurolidine/heparin in hemodialysis patients to reduce risk of CRSBIs, which are associated with very significant clinical, economic, and quality of life burdens in this vulnerable patient population,” Dr Agarwal’s team concluded.

Disclosure: This research was supported by CorMedix, Inc. Please see the original reference for a full list of disclosures.

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Researchers evaluated the efficacy and immunogenicity of an RSV vaccine among high-risk older adults in an ongoing, randomized, placebo-controlled, phase 3 trial (ClinicalTrials.gov Identifier: NCT04886596). Patients considered at increased risk for severe RSV disease were aged 60 years and older with coexisting cardiorespiratory or endocrine/metabolic conditions.

The RSV vaccine was an AS01_E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA). Patients were randomly assigned 1:1 to receive either the RSV vaccine (n=12,467) or placebo (n=14,499) prior to the start of the RSV season. The primary study objective was to evaluate the efficacy of the RSV vaccine against the first episode of RSV-associated LRTI or RSV-associated ARI during a single RSV reason. Outcomes were compared between patients with vs without coexisting conditions of interest, and immunogenicity was assessed in a post hoc analysis.

Baseline demographics were similar between patients in the vaccine and placebo groups (mean age, ~69.5 years; ~52% women; ~79% White), as were the number of patients in each group with at least 1 coexisting condition associated with increased risk for severe RSV disease (39.6% and 38.9%, respectively).

Analysis of patients at increased risk for RSV disease showed that the incidence of RSV-associated LRTI was higher among placebo recipients (incidence rate [IR], 6.6-8.9 per 1000 person-years) compared with vaccine recipients (IR, 5.3 per 1000 person-years). Results were similar in regard to the incidence of RSV-associated ARI (IR, 15.2-17.8 vs 13.1 per 1000 person-years, respectively).

The efficacy of the RSV vaccine against RSV-associated ARI was 81.0% (95% CI, 58.9-92.3) in patients with at least 1 condition associated with increased risk for severe disease. For patients with cardiorespiratory conditions and those with endocrine or metabolic conditions, vaccine efficacy was 88.1% (95% CI, 60.9-97.7) and 79.4% (95% CI, 49.4-93.0), respectively. For patients with at least 2 of these conditions, vaccine efficacy was 88.0% (95% CI, 60.5-97.7).

Further analysis showed that the efficacy of the RSV vaccine was higher against RSV-associated LRTI. Vaccine efficacy was 94.6% (95% CI, 65.9-99.9) in patients with at least condition of interest, with efficacy rates of 92.1% (95% CI, 46.7-99.8) and 100% (95% CI, 74.0-100) observed in those with cardiorespiratory or endocrine/metabolic conditions, respectively. For patients with at least 2 of these conditions, vaccine efficacy was 92% (95% CI, 46.1-99.8).

In regard to immunogenicity, increases in RSV-A- and RSV-B-neutralizing geometric mean titers between baseline and 31 days after vaccination were higher among patients with (11.0-fold and 9.1-fold increase, respectively) vs without (9.8-fold and 8.3-fold increase, respectively) at least 1 condition of interest.

This study may have been limited as the efficacy and immunogenicity analyses were descriptive and not adjusted for multiplicity.

“Given that people with these chronic illnesses bear the brunt of the RSV disease burden in older adults, this vaccine could have a positive impact on public health,” the researchers concluded.

Disclosure: This research was supported by GlaxoSmithKline Biologicals SA; and multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Despite findings that demonstrate treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) reduces the risk for heart and kidney failure in patients with type 2 diabetes and CKD, these risks remain high. Compared with these traditional treatments, SGLT2 inhibitors and MRA have demonstrated superior cardiovascular and kidney outcomes. However, real world implementation has been slower than anticipated.

To estimate the lifetime benefit of combination treatment of SGLT-2 inhibitors (canagliflozin) and MRA (finerenone) in patients with type 2 diabetes and CKD, researchers derived data from the placebo-controlled randomized clinical trials CREDENCE (ClinicalTrials.gov Identifier: NCT02065791) and FIDELIO-DKD (ClinicalTrials.gov Identifier: NCT02540993), respectively.

In these respective trials, the researchers assessed the safety and efficacy of canagliflozin and finerenone compared with placebo and in addition to conventional treatment of ACE inhibitors and ARBs.  

The primary endpoint of the study was a composite of a sustained doubling of serum creatinine, end-stage kidney disease (defined as a sustained estimated glomerular filtration rate of less than or equal to 15 mL/min/1.73 m², initiation of dialysis for at least 30 days, or kidney transplantation), or death from kidney failure. The secondary outcome was end-stage kidney disease, with heart failure hospitalization and all-cause mortality also examined as endpoints.

The mean ages of patients in the CREDENCE (N=4401) and FIDELIO-DKD (N=5674) trials were 63.0 and 65.6 years, respectively, whereas the mean estimated glomerular filtration rates were 56.2 and 44.3 mL/min/1.73 m², respectively. All patients were prescribed an ACE inhibitor or ARB.

Compared with conventional treatment alone, an SGLT-2 inhibitor and MRA as an adjunct to conventional treatment yielded a combined treatment effect on:

• Primary composite kidney function (hazard ratio [HR], 0.50; 95% CI, 0.44-0.57);
• End-stage kidney disease (HR, 0.59; 95% CI, 0.51-0.69);
• Hospitalization for heart failure (HR, 0.52; 95% CI, 0.44-0.63); and,
• All-cause mortality (HR, 0.75; 95% CI, 0.65-0.86).

For patients who initiated treatment at 50 years of age, the estimated event-free survival gains of combined therapy and conventional treatment were 16.7 years (95% CI, 15.5-17.9) and 10.0 years (95% CI, 6.8-12.3), respectively, culminating in a gain of 6.7 years (95% CI, 5.5-7.9).

The overall survival gains of combined and conventional treatments were 22.1 years (95% CI, 21.2-23.0 and 20.1 years (95% CI, 15.9-21.3), respectively, with a difference of 2.0 years (95% CI, 1.1-2.9).

The researchers also found a greater event-free gain among younger patients compared with older patients, as a patient aged 60 years gained an additional 3.2 years (95% CI, 2.7-3.7), whereas a patient aged 70 years gained an additional 1.1 years (95% CI, 0.9-1.2).

Study limitations include the early discontinuation of the CREDENCE trial, which resulted in a potential overestimate of the combined pharmacological treatments’ incremental survival gain, and the lack of data on long-term efficacy. 

According to the researchers, “Combined disease-modifying pharmacological treatment with SGLT2 inhibitors, MRAs and endothelin receptor antagonists, compared with conventional treatment, may substantially improve long-term health outcomes, including kidney failure and heart failure hospitalization, and prolong overall survival in patients with type 2 diabetes and CKD.”

Disclosure: Multiple study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers conducted a case series analyzing brain donors who died before age 30 involved in contact sports and reported on the neuropathological and clinical symptomatology of these individuals.

A total of 152 deceased brain donor patients were analyzed and CTE was diagnosed in 63 of these patients (41.4%; median [IQR] age, 26 [24-27]). Out of the 63 brain donors who were diagnosed with CTE, 95.2% (60 individuals) were found to have mild CTE, classified as stages I or II.

Out of the 152 brain donors, 11 (7.2%) were female and 141 (92.8%) were male. In terms of racial background, 1 (0.7%) identified as American Indian or Alaska Native, 27 (17.8%) as Black, 111 (73.0%) as White, and 13 (8.6%) had missing or other race information.

Brain donors diagnosed with CTE tended to be older (mean difference, 3.92 years; 95% CI, 2.74-5.10 years; P <.001). They were also more likely to identify as Black (16 [25.4%]; P =.047).

Moreover, individuals with CTE exhibited a higher level of education (28 [44.4%] compared with 17 [19.1%] donors with a college degree or higher; P <.001). However, there were no significant differences in the cause of death between those with CTE. Suicide remained the most common cause, followed by unintentional overdose.

Out of the 128 amateur athletes, 45 (35.2%) were found to have CTE. Similarly, among the 63 donors with CTE, 45 (71.4%) were amateurs. The group of amateur athletes consisted mainly of football players (78 [60.9%]), soccer players (22 [17.2%]), hockey players (10 [7.8%]), and wrestlers (9 [7.0%]).

Out of the 63 athletes diagnosed with CTE, 45 (71.4%) were male participants involved in amateur sports such as American football (78 [60.9%]), hockey (10 [7.8%]), , soccer (22 [17.2%]), and wrestling (9 [7.0%]).A single female athlete with CTE played collegiate soccer.

Among those who played football, individuals with CTE had a significantly longer playing career compared to those without CTE, (mean difference, 2.81 years, 95% CI, 1.15-4.48 years).

There was a significantly higher prevalence of cavum septum pellucidum (26 [63.4%] vs 19 [30.2%]; P <.001), enlargement of the frontal horns of the lateral ventricles (17 [41.4%] vs 13 [20.4%]; P =.02), and a thalamic notch (5 [11.9%] vs 1 [1.5%]; P =.03) in individuals with CTE compared with those without CTE.

Perivascular pigment-laden macrophages in the frontal subcortical white matter were significantly more prevalent in individuals with CTE (94.5%) compared with those without CTE (70.3%; P <0.001).

Among the 92 football players, the duration of football play was found to have a significant association with CTE status (odds ratio [OR], 1.20; 95% CI, 1.07-1.34; P =.002) and the presence of perivascular macrophages in the frontal white matter (OR, 1.26; 95% CI, 1.08-1.47; P =0.003).

However, it was not linked to ventricular enlargement, cavum septum pellucidum, thalamic notch abnormalities, or white matter rarefaction.

The study’s findings may be limited as it does not assess the incidence or prevalence of CTE in the general population or young contact sport athletes and others exposed to repetitive head impacts.

The researchers concluded, “Future studies comparing RHI-naive with RHI-exposed young brain donors will help isolate the clinical and neuropathologic effects of RHIs independent of CTE.”

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The post hoc analysis of the SPRINT (Systolic Blood Pressure Intervention Trial; ClinicalTrials.gov Identifier: NCT01206062) trial sought to estimate the association between SBP TTR with incident AF and determine a more appropriate BP control performance measurement for preventing AF.

The multicenter, open-label, randomized controlled SPRINT trial compared the effects of an intensive SBP target of less than 120 mm Hg with a standard SBP target of less than140 mm Hg in patients with hypertension. The current analysis included SPRINT participants with 2 or more follow-up SBP measurements during the first 3 months of the trial and excluded those with missing or uninterpretable baseline ECG results, those without any follow-up ECG results, and those with AF at baseline.

The primary outcome was incident AF, which was the first occurrence of AF measured by standard 12-lead ECG at year 2, year 4, and at a close-out visit in SPRINT. SBP TTR was considered the proportion of time that SBP remains within target range and was calculated with use of Rosendaal linear interpolation method.

The analysis included 7939 participants, with a mean age of 68±9 years who were 35% women. The SBP TTR and mean SBP achieved in the first 3 months among all participants were 59% (IQR, 32%-84%) and 129±12 mm Hg, respectively.

For patients without baseline AF, 187 incident AF cases occurred during a median follow-up of 3.8 years (28,029 person-years; incident rate, 6.7 per 1000 person-years; 95% CI, 5.8-7.7).

Each 10% increase in SBP TTR had a significant association with a reduced risk for incident AF in the unadjusted model and the model adjusted for demographics. After further adjustment for treatment group, medical history, and baseline SBP, a 10% increase in TTR was significantly associated with a 7% decreased risk for incident AF (hazard ratio [HR], 0.93; 95% CI, 0.88-0.97; P =.003).

The fully adjusted model showed that HRs comparing the reference category of TTR of 0% to less than 32% vs TTR of 32% to less than 59%, 59% to less than 84%, and 84% to 100% were 0.82 (95% CI, 0.56-1.20), 0.55 (95% CI, 0.36–0.84), and 0.58 (95% CI, 0.37-0.90), respectively (P value for trend =.003).

Restricted cubic spline curve analysis revealed a linear and inverse association between SBP TTR and incident AF (P_nonlinearity =.338). The risk for AF had a steady decrease with increasing TTR between 0% and 83%.

In a sensitivity analysis, a consistent trend was observed for use of 110 to 140 mm Hg as the SBP target range for both treatment groups. When assessing the sensitivity using TTR in months 0 to 12 instead of months 0 to 3, increased SBP TTR continued to be significantly associated with a reduced risk for incident AF in the fully adjusted model (HR, 0.93 per 10%; 95% CI, 0.88-0.98; P =.010).

Among several limitations, it is possible that some nonpersistent or asymptomatic AF cases were not detected owing to intermittent screening rather than long-term or continuous monitoring. Also, the study excluded patients with diabetes or previous stroke and did not assess the effects of individual drugs and doses on AF.

“Efforts to attain an SBP range within 110 to 140 mm Hg over time may be an effective BP control strategy from the perspective of AF prevention,” wrote the investigators.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Chronic pain disorders are linked to decreased high-frequency (HF) index or cardiac parasympathetic modulation. HRV has been utilized to measure cardiac autonomic modulation in response to painful stimulation. However, the research in this area has been conducted under specific clinical conditions or for chronic pain in general. Thus, researchers conducted a systematic review to assess the at rest HRV responses of adults suffering from chronic musculoskeletal pain compared with healthy individuals. The literature search was conducted on May 12, 2021, and the review included 20 studies and 3087 participants.

The 20 studies included in the analysis investigated HRV in temporomandibular disorders, neck pain, whiplash, low back pain, fibromyalgia, and fibromyalgia and temporomandibular disorders. During sleep, rest, and orthostatic challenges, individuals with temporomandibular disorders exhibit lower HRV than control groups. Reduced HRV compared with control groups was also shown in patients with neck pain or chronic whiplash. In patients with low back pain, sympathetic hyperactivity was observed at rest compared with healthy patients. Individuals with fibromyalgia exhibited higher levels of sympathetic activity and lower levels of parasympathetic activity than control groups. This was observed over a period of 24 hours, during daytime and nighttime, and autonomic tests, while in the supine position, during normal quiet breathing, while sleeping, and at rest. Reduced HF was observed in patients with fibromyalgia and temporomandibular disorders compared with healthy controls. Finally, compared with healthy controls, a decrease in parasympathetic and an increase in sympathetic modulation at rest was found in patients with musculoskeletal pain.

Study limitations include a small number of studies, a small sample size, and different HRV measurement protocols.

The researchers concluded, “We observed reduced HRV in adults with musculoskeletal pain when compared with controls, at rest. However, no definitive conclusions can be drawn since the evidence is heterogeneous moderate quality. Further high-quality research with standardized definitions of measurements is needed.”

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Close to 40% of aflibercept-resistant eyes with DME maintained a fluid-free macula at 12 months after switching to faricimab. They also achieved a mean reduction in central macular thickness (CMT) (from baseline 400.2 [385.3–415.3] to 340.6 [324.3–356.9] µm by the study’s conclusion; P <.01).

A cohort of 51 eyes of 51 participants from a private practice in Texas presented with refractory DME. All participants had undergone 8 or more aflibercept injections in the preceding 12 months before switching to faricimab. Patients were evaluated using optical coherence tomography (OCT), as well as Snellen charts converted to logarithm of the minimum angle of resolution (logMAR).

In 12 months after a switching to faricimab with a treat-and-extend protocol, 39.2% achieved treatment intervals of 8 weeks or longer, along with fluid resolution. Additionally, 21.6% increased visual acuity by 3 Snellen lines or more. In all, visual acuity when starting faricimab was 0.60 (0.54–0.66) logMAR, and improved in 12 months to 0.47 (0.41–0.53) logMAR (P <0.01).

“In the DME patients meeting the study’s primary outcome (approximately 40%), fewer treatments could be administered over 12 months without compromising the functional and/or anatomical outcomes of the patient,” according to the study’s author. He also notes that, after switching to faricimab, “the mean decrease in CMT on OCT was manifested by 4 months and remained stable throughout the study period of 12 months, whereas the mean improvement in visual acuity at 4 months was approximately half the value obtained at 12 months, suggesting visual acuity may gradually improve over 12 months in this study population.”

Previous research indicates long-term visual acuity depends on resolution of residual edema. This suggests that the absence of any clinically meaningful treatment response in the majority of the patients after switching to faricimab may be due to enduring retinal damage and photoreceptor loss prior to the switch.

Limitations of this interventional case series include its retrospective nature, lack of control set, and visual acuity observed with Snellen charts converted to logMAR, instead of ETDRS measurement.

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Thyroid eye disease (TED) affects the ocular surface and orbital tissues. The clinical activity score (CAS) measures disease activity and guides treatment. In previous studies, optical coherence tomography angiography (OCT-A) has been used to detect deterioration in radial peripapillary capillary (RPC) density in glaucoma or ischemia and parapapillary deep vessel density in glaucomatous optic neuropathy. However, parapapillary deep vessel density has not been studied in TED. Therefore, researchers aimed to evaluate peripapillary microvascular change in the choroid of patients with TED using automated image processing. 

The study participants were divided into 3 groups: group 1 included the controls (n=40), group 2 included inactive TED (ITED, n=22), and group 3 included active TED (ATED, n=19). The mean age of the control group was 43.9, and the TED group was 45.0. Among these, 24 of the 40 in the control group and 21 of the 41 in the TED group were women. 

Annular and hemifield RPC density was significantly lower in the ATED group compared with participants in the control and ITED groups, while parapapillary retinal nerve fiber layer (pRNFL) thickness was significantly higher in the ATED group than controls. There was a notable rise in the density of parapapillary choroid microvasculature (PPCMv) in the ATED group for the entire ring area. 

In the DON subgroup, there was a significant reduction in RPC density, but no changes were observed in pRNFL thickness and PPCMv density. PPCMv density was correlated with pRNFL thickness (r=0.334; P =.002). The RPC density was correlated with the thyroid-stimulating hormone receptor antibody (TSHr AB) level (r<-0.396; P <.001). CAS was positively correlated with parapapillary choroid microvasculature density (r=0.349; P =.001) and pRNFL thickness (r=0.293; P =.008), and negatively correlated with RPC density (r=-0.321; P =.004).

“These results suggest that altered peripapillary microvascular perfusion may contribute to DON,” the researchers explain. “As the level of clinical activity increases, so does the change in the peripapillary parameters.”

Study limitations include the small number of non-DON and DON subgroups. Additionally, no longitudinal RPC density and PPCMv density data were available. Smoking may have affected the results of OCT-A.

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Sotatercept is a first-in-class activin receptor type IIA-Fc fusion protein. The application is supported by data from the double-blind, placebo-controlled phase 3 STELLAR study (ClinicalTrials.gov Identifier: NCT04576988), which evaluated the efficacy and safety of sotatercept in 323 adult patients with PAH (WHO Group 1). 

Study participants who were receiving stable background PAH therapy were randomly assigned 1:1 to receive either sotatercept or placebo administered subcutaneously every 3 weeks. The primary endpoint was exercise capacity, which was measured by the change from baseline in 6-minute walk distance (6MWD) at 24 weeks.

Results showed a statistically significant and clinically meaningful improvement in 6MWD among patients treated with sotatercept compared with placebo (34.4m vs 1.0m, respectively; Hodges-Lehmann estimated difference, 40.8m [95% CI, 27.5-54.1]; P <.001). 

Sotatercept was also associated with statistically significant improvements in 8 out of 9 secondary outcome measures, including the proportion of participants achieving multicomponent improvement (defined as improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide level, and either improvement in WHO functional class [FC] or maintenance of WHO FC II), and the outcome measure of time to death or the first occurrence of a clinical worsening event. An assessment of the Cognitive/Emotional Impacts domain score of PAH-SYMPACT^® did not result in a statistical significant change.

Compared with placebo, the following adverse events occurred more frequently with sotatercept: epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.

“Despite advances in the treatment of PAH over the last 2 decades, there is still a significant need to improve outcomes for patients,” said Dr Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. “The FDA’s acceptance of this application is an exciting milestone in our journey to bring this novel activin signaling inhibitor to patients. Based on the profound improvements across primary and secondary outcome measures in the phase 3 STELLAR trial, we believe sotatercept has the potential to transform the treatment of patients with PAH.”

A Prescription Drug User Fee Act target date of March 26, 2024 has been set for the application.

The post Sotatercept Gets Priority Review for Pulmonary Aterial Hypertension appeared first on The Cardiology Advisor.

Emerging research indicates an association between metabolic syndrome and RCC outcomes. The current study extends the findings on prognosis.

Among 4092 patients undergoing partial nephrectomy (PN) and 2056 patients undergoing radical nephrectomy (RN) for clinical T1 tumors, pathologic upstaging to pT3a occurred in 4.9% of the PN and 23.3% of the RN group. Along with larger preoperative tumor size and older age, pre-existing diabetes increased the probability of upstaging in both the PN and RN groups, Deepak K. Pruthi, MD, of UT Health San Antonio in San Antonio, Texas, and colleagues reported in The Journal of Urology.

In the PN group, diabetes significantly increased the odds of upstaging to pT3a by 65%, whereas male sex increased the odds by 62%. Each 1 cm increase in preoperative tumor size increased the odds of upstaging by 26%. Each 1 kg/m² unit increase in body mass index (BMI) also was significantly associated with 3% increased odds of upstaging, as was every 1-year increase in age.

In the RN group, diabetes and male sex significantly increased the odds of upstaging to pT3a by 32% and 18%, respectively. Each 1 cm increase in preoperative tumor size increased the odds by 24%. Each 1-year increase in age was significantly associated with 2% increased odds of upstaging.

Diabetes was a risk factor for upstaging across PN and RN groups, sex, age, preoperative tumor size, and BMI, Dr Pruthi’s team reported.

According to the investigators, “diabetic patients represent a unique population for whom both nephron-sparing surgery is preferred if feasible [to delay chronic kidney disease], but these patients may harbor higher oncologic risk.”

Patients with hilar tumors undergoing PN and RN also had 1.9- and 2.2-fold increased odds of upstaging to pT3a, respectively, the investigators reported.

“With advancements in systemic therapies and as the utilization of [small renal mass] biopsy proliferates, identifying patients at risk for pathological upstaging will become increasingly important for patient counseling,” Dr Pruthi’s team wrote. “Hypothetically, patients who would be predicted to be upstaged may choose to undergo renal mass biopsy and, if found to have high-risk disease, they may undergo treatment pathways that, in the future, may include neoadjuvant immunotherapy.”

Patients received care at 11 centers in 7 countries across North America, South America, Europe, and Asia, so the study captures the diversity of the RCC population. The study was limited by a lack of information on patients’ smoking history.

“To date, none of the validated nomograms for renal cell carcinoma include obesity or other effects of metabolic syndrome for localized renal masses,” Simon P. Kim, MD, of the University of Colorado in Aurora noted in an accompanying editorial. Whether reducing obesity and controlling diabetes decreases the risk for aggressive RCC remains to be seen.

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Ambiguity as to whether older patients with AF living with frailty should be switched from VKA to NOAC led the researchers to conduct a superiority trial to determine the more efficacious treatment approach. The primary endpoint was a major or clinically relevant nonmajor (CRNM) bleeding complication, accounting for death as a competing risk. An intention-to-treat analysis was conducted. Thrombotic events were included as secondary endpoints.

The researchers conducted a pragmatic, open-label, multicenter, randomized controlled trial (FRAIL-AF) in the Netherlands from January 2018 through June 2022. This included 1323 patients randomly assigned to either switch from a VKA to a NOAC (n=662) or continue with a VKA (n=661). Included patients were older, living with frailty (age ≥75 years plus a Groningen Frailty Indicator (GFI) score ≥3) and had AF. Patients with valvular AF or with a glomerular filtration rate of less than 30 mL/min/1.73m² were excluded.

All patients were followed-up through 12 months (mean follow-up duration, 344 days), and 90 patients died during follow-up (31 cardiovascular deaths [12 intervention arm; 19 control arm]; 10 bleeding deaths [5 in each arm]). The researchers defined a major bleeding event as bleeding in a critical area or organ, bleeding leading to a decrease in hemoglobin level of at least 2 g/dL, bleeding leading to a transfusion of 2 or more units, or a fatal bleeding. A CRNM bleeding complication was defined as not major bleeding but leading to face-to-face consultation, health care professional medical intervention, or hospitalization.

Among all patients (mean age, 83 years; median GFI, 4), 163 primary endpoint events occurred (101 in the switch arm; 62 in the continue arm), and as per prespecified analysis protocol, the trial was stopped for futility.

The researchers noted the primary endpoint hazard ratio (HR) was 1.69 (95% CI, 1.23-2.32; P =.00112). The thromboembolic events HR was 1.26 (95% CI, 0.60-2.61). Numerically, the intervention arm vs control arm had more urogenital (20 vs 11) and gastrointestinal (17 vs 4) bleedings. HR for the first 100 days was 1.17 (95% CI, 0.70-1.96) in sensitivity analysis and 2.10 (95% CI, 1.40-3.16) for days 100 to 365.

Study limitations include a patient population tolerant to VKA treatment, the choice of NOAC at the discretion of treating physicians, and the underpowered sample size.

“In this pragmatic randomized trial in older patients with atrial fibrillation, living with frailty, more major and/or clinically relevant non-major bleeding complications were observed when switching from vitamin K antagonist treatment to a non-VKA oral anticoagulant, compared to continuing VKA treatment,” the researchers wrote. “This higher bleeding risk with NOACs was not off-set by a reduction in thromboembolic events, albeit the risk of thrombo-embolic events was low in both treatment arms.”

Disclosure: This research was supported by Boehringer-Ingelheim, BMS-Pfizer, Bayer, and Daiichi-Sankyo. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers evaluated the impact of RCV on global CRS incidence in a systematic review. The researchers identified age-stratified data on rubella seroprevalence from previous research published from January 2012 to September 2020. Age-specific fertility rates, total number of live births from 1996 to 2019, and survival data were identified from participating countries via United Nations’ population databases. Countries in which RSV had been introduced were divided into World Health Organization (WHO) regions, and annual vaccination data were obtained from country-specific submissions. 

A total of 129 datasets from 70 countries were assessed to estimate the global CRS burden. Four catalytic models were used to evaluate seroprevalence data and calculate the mean age-specific prevaccination force of infection (ie, rate at which susceptible individuals are infected). The models were designed with the assumption that prevaccination force differed between individuals younger than 13 years and those 13 years and older. A transmission model was used to calculate the incidence of CRS per 100,000 live births and the annual number of infants born with CRS from 1996 to 2019. The transmission model also was designed to stratify populations by maternal immunity and by those who were susceptible, pre-infectious, infectious, and immune.

In 2019, the highest estimated regional CRS incidence per 100,000 live births was noted in the African region (64; 95% CI, 24-123), followed by the Eastern Mediterranean region (27; 95% CI, 4-76). Of note, the incidence of CRS in the African region decreased from 119 (95% CI, 62-209) to 64 (95% CI, 24-123) between 2012 and 2019.

Of 22 countries where RCV was not introduced by 2019, 17 were in in the African region (17% of global live births) and 5 were in the Eastern Mediterranean region (7% of global live births). Further analysis of the African region showed that South Africa had an estimated CRS incidence of 36 (95% CI, 2-93), whereas Nigeria had an estimated incidence of 130 (95% CI, <1-337). In the Eastern Mediterranean region, the estimated CRS incidence ranged from 50 (95% CI, <1-173) in Pakistan to 91 (95% CI, <1-202) in Sudan.

Low CRS incidence was observed in countries where RCV had been introduced. The estimated incidence of CRS was less than 1 in both the Western Pacific and Southeast Asian regions, as more than 95% of births had occurred following the introduction of RCV. 

The estimated global number of annual CRS diagnoses was 121,000 (95% CI, 70,000-191,000) in 2010. However, after the introduction of RCV, the estimated global number of annual CRS diagnoses decreased to 32,000 (95% CI, 13,000-60,000) by 2019, representing an overall reduction of 73% from 1996 to 2019. The highest estimated number of CRS diagnoses in 2019 were noted among Ethiopia, Republic of the Congo, Niger Pakistan, Nigeria, Uganda, and Sudan, with more than 1000 diagnoses annually.

Following the introduction of RCV, an estimated 229,000 (95% CI, 131,00-368,000) diagnoses of CRS have been averted. The highest number of averted CRS diagnoses was observed in the Southeast Asian region (125,000; 95% CI, 37,000-111,000).

Limitations of this study include the lack of seroprevalence data for certain countries, as well as the possibility that some datasets were not representative of surveyed populations. Moreover, the reduction in the transmission and incidence of CRS may have been overestimated.

According to the researchers, “With sustained coverage and the introduction of RCV into the remaining countries where it has not yet been introduced, further reductions are possible.”

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The researchers searched 4 databases for trials with a parallel-group design of oral drugs for PDN published in the last 20 years and evaluated the magnitude of the placebo or nocebo responses, Cochrane risk of bias, heterogeneity, and moderators of the 21 trials they identified, which together included 2425 placebo-treated patients.

The overall mean pooled placebo response was a -1.54 change in pain intensity from baseline with a moderate effect size. The pooled placebo 50% response rate was 25%. The percentage of patients with adverse events in the placebo arms was 53.3% and 5.1% of those patients dropped out due to these events.

The year of study initiation was the only significant moderator of placebo response. More recent trials tended to be longer and bigger and to include older patients.

“Our findings confirm the magnitude of placebo and nocebo responses, identify the year of study initiation as the only significant moderator of placebo response, draw attention to contextual factors such as confidence in PDN treatments, patients’ previous negative

experiences, intervention duration, and information provided to patients before enrollment,” the study authors wrote.

Study limitations include the absence of a study arm in which participants received no treatment in the trials analyzed, which prevented effects from being controlled for confounding factors such as the natural history of the disease and regression to the mean. In addition, the study’s statistical analysis was not adjusted for multiple comparisons, and data at the level of the individual patient was not available to the researchers.

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To determine the effects of the GPNC model on risk for gestational diabetes and its progression, researchers performed a secondary analysis of a single-center, parallel-group, randomized clinical trial (ClinicalTrials.gov Identifier: NCT02640638) conducted from February 2016 to March 2020 at a large health care system Greenville, South Carolina.

Patients were aged 14 through 45 years with pregnancies earlier than 21 weeks. The researchers stratified the sample by race and ethnicity and randomly assigned patients to receive either group-based care (via the Centering Healthcare Institute’s Centering Pregnancy curriculum) or individual-based care.

The researchers separated the GPNC group into groups of 8 to 12 patients for ten 2-hour sessions. Each patient in the IPNC group received traditional individual prenatal care as recommended by the American College of Obstetricians and Gynecologists for a total of 13 visits. Patients in the GPNC group were also allowed IPNC visits as needed.

Patients completed a baseline survey at less than 24 gestational weeks and a second survey at 30 to 36 gestational weeks. Surveys included questions about demographics, medical and reproductive history, and maternal health behavior. Patients self-reported their race and ethnicity.

The primary outcome was the incidence of gestational diabetes, which the researchers determined via administering the 50-g oral glucose challenge between 24 and 30 weeks of gestation. Secondary outcomes included progression of gestational diabetes according to the White classification (A1 to A2 gestational diabetes) and obstetric adverse outcomes associated with poor glycemic control, such as:

• Primary cesarean delivery;
• Pre-eclampsia; and,
• Large-for-gestational-age (LGA) birth.

The researchers used an intention-to-treat (ITT) approach to compare primary and secondary outcomes between the GPNC and IPNC groups, whereas they used a modified ITT approach for sensitivity analyses.

The ITT population included a total of 2348 patients, of whom 1175 received GPNC and 1173 received IPNC. Of the total sample, 91.3% of patients had completed the screening for gestational diabetes. The patients self-identified as:

• Black (40.5%);
• White (36.8%);
• Hispanic (21.4%); and,
• Other race or multiracial (1.3%).

Baseline characteristics and prognostic factors were similar between groups, but the rate of smoking 3 months before pregnancy was slightly higher in the IPNC group (38.7%) compared with the GPNC group (32.9%).

The overall incidence of gestational diabetes was 6.7%, with no significant difference between the GPNC (7.1%) and IPNC (6.3%) groups. The adjusted risk difference (RD) was 0.7% (95% CI, -1.2% to 2.7%). The incidence of gestational diabetes did not vary across patients of different races and ethnicities, with adjusted RDs of:

• 0.5% (95% CI, -2.0% to 3.0%; Black patients);
• -0.5% (95% CI, -5.8% to 4.9%; Hispanic patients); and,
• 2.6% (95% CI, -0.7% to 6.0%; White patients).

Of those with gestational diabetes, 49% of patients (48.2% of the GPNC group and 50.0% of the IPNC group) progressed to A2 gestational diabetes. The adjusted RD was -6.1% (95% CI, -21.3% to 9.1%).

The researchers measured no significant difference in the incidence of obstetric adverse events between groups. However, proportions of patients experiencing pre-eclampsia, primary cesarean delivery, and LGA birth were slightly lower in the GPNC group compared with the IPNC group, with adjusted RDs of:

• -7.9% (95% CI, -17.8% to 1.9%; pre-eclampsia);
• -8.2% (95% CI, -12.2% to 13.9%; cesarean delivery); and,
• -1.2% (95% CI, -6.1% to 3.8%; LGA).

Study limitations include its early termination due to COVID-19, which limited the sample size, and low attendance among patients in the GPNC group.

The researchers concluded, “In this [randomized controlled trial] among pregnant individuals, participants receiving GPNC had similar risk of developing [gestational diabetes], compared with participants receiving IPNC, suggesting that GPNC could be a feasible care option for some patients.”

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Long-term arteriovenous access is essential in treating patients with kidney failure. Although a higher body mass index (BMI) has been associated with lower mortality rates among hemodialysis patients, prior studies have linked obesity to adverse outcomes in access creation and maintenance, such as worse long-term fistula survival.

To assess the clinical outcomes of AVF in patients with and without obesity, researchers conducted a single-center, retrospective review of all patients with primary upper extremity autogenous AVFs from January 1999 to December 2019.

The researchers assigned patients into 4 categories based on BMI:

• Non-Obese (<30 kg/m²);
• Class I (30.0-34.9 kg/m²);
• Class II (35.0-39.9 kg/m²); and,
• Class III (>40 kg/m²).

The review covered patient information regarding successful progression to hemodialysis (maturation), re-intervention, continuous hemodialysis for 3 months (functional dialysis), and patency.

Exclusion criteria included percutaneous AVF placement, prior AVF revisions, or an arterio-venous graft located on the same extremity. 

The primary outcomes were time to maturation and functional dialysis. Secondary outcomes included dialysis site functionality duration and access patency.

The trial consisted of 2291 patients (mean age, 61 years; SD, 15 years) of whom 67% were women. The non-obese, Class I, Class II, and Class III obesity groups contained 41%, 29%, 19%, and 11% of patients, respectively. The researchers noted no major differences in statin or antiplatelet use between the BMI groups. 

As the category of obesity increased, the proportion of access-related complications within 90 days of the procedure increased (non-obese, 22.5%; Class I, 34.0%; Class II, 50.8%; Class III, 78.2%; P=.001).

Compared with patients in the Class I obesity (5%) and non-obese (3%) groups, those in Class II (9%) and Class III (12%) obesity groups had a higher risk of early thrombosis.

The researchers identified a two-fold increase in procedures to facilitate access maturation in the Class II (51%) and Class III (74%) obesity groups compared with the non-obese (34%) and Class I obesity (22%) groups. Multivariate analysis revealed associations between maturation procedures and Class II (HR, 1.8; 95% CI, 1.1-2.7; P=.03) and Class III (HR, 2.5; 95% CI, 1.1-3.7; P=.02) obesity groups.

Compared with patients in the Class II (79%; SD, 3%) and Class III (62%; SD, 4%) obesity groups, those in the Class I obesity (87%; SD, 2%) and non-obese (93%; SD, 4%) groups showed greater 3-year rates of secondary patency. 

Study limitations included its occurrence at a single-center, the predominantly Hispanic population, and the low placement of grafts within its population.

According to the researchers, “Increasing obesity class is associated with an increased number of procedures to achieve AVF maturation and is associated with poorer patency and functionality as the category of obesity increases.”

The post Obesity Linked to Worse AVF Access Maturation Outcomes appeared first on The Cardiology Advisor.

Limited data exist related to risk factors for severe RSV disease in adults and which patients should undergo a nasopharyngeal swab for RSV. Investigators therefore aimed to evaluate the risk factors associated with RSV infection in adults and to assess the clinical characteristics of adults with RSV and severe RSV disease.

The investigators conducted a retrospective, single-center cohort study at L. Sacco University Hospital, Milan, Italy, from October 2022 through March 2023. The study included 717 consecutive adult patients (47% female) referred to the emergency department with acute respiratory failure (aRF) or influenza-like symptoms, who were subsequently tested per protocol (by means of a multiplex nasopharyngeal swab) for SARS-CoV-2, InvA/B, and RSV. Severe disease was defined as respiratory failure, shock, sepsis, the need for respiratory support, or in-hospital death.

The investigators found that 101 patients (14.1%) had a positive swab for InvA; 62 patients (8.6%) were positive for SARS-CoV-2; 61 patients (8.5%) had RSV; and 26 patients (3.6%) had other respiratory viruses.

Compared with patients with InvA and those who were negative for RSV, patients positive for RSV were older (P =.028), had higher prevalence of chronic heart failure (P =.001), had a higher Charlson index (P =.001), were more frequently treated with inhaled corticosteroids (ICS) (P =.026) and immunosuppressants (P =.018), and were more likely exposed to bronchodilators (P =.032).

Compared with patients with InvA, the investigators noted patients with RSV had more frequent history of immune depression and hepatopathy. Cumulative exposure to ICS therapy did not differ between those with InvA and RSV.

Patients with RSV had the highest occurrence of acute respiratory failure (62.7%) and severe disease (70.5%) compared with the overall study cohort. The investigators noted RSV mortality was similar to mortality of patients with InvA (6.6% vs 5.9%; P =.874), respectively.  

RSV infection was predicted by chronic exposure to immunosuppressants (odds ratio [OR], 3.661; 95% CI, 1.246-10.754; P =.018); heart failure (OR, 3.286; 95% CI, 1.031-10.835; P =.041); and chronic exposure to ICS (OR, 2.377; 95% CI, 1.254-4.505; P =.008).

Severe RSV disease was predicted by past/active smoking (OR, 7.347; 95% CI, 1.301-41.500; P =.024); leucocytes at least 8000 cells/µL (OR, 5.929; 95% CI, 1.090-32-268; P =.039); and glycemia at least 120 mg/dL (OR, 5.839; 95% CI, 1.155-29.519; P =.033). Although smoking history was included in this model, it was not included in the model related to RSV infection because of missing data on smoking habits for 30% of patients.

Study limitations include the retrospective and monocentric design, underpowered sample size, and lack of ethnic heterogeneity.

“Overall, respiratory failure and severe disease were more frequent in RSV patients,” said study authors, who concluded that “Preventive strategies for RSV infection such as vaccination are highly warranted, especially in older patients with cardiovascular and chronic respiratory conditions.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The post hoc analysis of the EMPHASIS-HF (ClinicalTrials.gov Identifier: NCT00232180) trial assessed the efficacy and safety of eplerenone in patients based on HFrEF duration.

Participants were aged 55 years or older with New York Heart Association functional class II symptoms, left ventricular ejection fraction of 30% or less, and were being treated with an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or both and a β-blocker (unless contraindicated) at the recommended dose or maximally tolerated dose.

Participants were randomly assigned to receive eplerenone (up to 50 mg daily) or placebo in addition to recommended therapy. HF duration was classified into 3 groups: less than 1 year, 1 to less than 5 years, and 5 years or longer. The primary outcome was the time to first occurrence of the composite of cardiovascular death or HF hospitalization.

The cohort included 2732 patients with HFrEF, mild symptoms, and data on HF duration. The median HF duration was 2.4 years (IQR, 0.4-7.0 years). The number of patients in each HF duration category was 975 (35.7%; mean age, 67.8±7.6 years) in the less than 1 year group, 769 (28.1%; mean age, 68.2±7.7 years) in the 1 to less than 5 years group, and 988 (36.2%; mean age, 69.8±7.5 years) in the 5 years or longer group. The median follow-up was 21 months. Patients who had a longer HF duration were more frequently men and older.

The incident rate per 100 patient-years of the composite of cardiovascular death or hospitalization for HF increased with greater HF duration. In the less than 1 year group it was 9.8 (95% CI, 8.4-11.4). In the 1 to less than 5 years group it was 13.5 (95% CI, 11.6-15.7). In the 5 years or longer group it was 17.6 (95% CI, 15.6- 19.8).

The benefit of eplerenone was consistent for all outcomes according to HF duration. The overall adjusted hazard ratio (HR) for eplerenone vs placebo for the primary outcome was 0.64 (95% CI, 0.54-0.76). For the less than 1 year group, the HR was 0.59 (95% CI, 0.42-0.82), for the 1 to less than 5 years group the HR was 0.72 (95% CI, 0.52-1.00), and in the 5 years or longer group, the HR was 0.59 (95% CI, 0.46-0.76; P_interaction =.54).

The number needed to treat (NNT) for the median trial duration regarding the primary outcome was 10 (95% CI, 8-14) for HF duration of 5 years or longer vs 14 (95% CI, 11-21) for HF duration of less than 1 year and 13 (95% CI, 10-19) for HF duration of 1 to less than 5 years. The NNT for all-cause mortality was 24 (95% CI, 15-95) for HF duration of 5 years or longer vs 34 (95% CI, 21-136) for HF duration of less than 1 year and 31 (95% CI, 19-125) for HF duration of 1 to less than 5 years.

The researchers noted that their study is not a prespecified analysis, and HF duration was obtained from questions on a case report form and was not independently verified. Also, the results may not be generalizable to all patients with HFrEF, and separate Cox regression analyses were conducted for each subpopulation based on HF duration, which may have affected the estimation of HRs.

“Eplerenone was efficacious and safe in patients with long-standing HFrEF, who obtained substantial reductions in mortality and morbidity with this treatment,” wrote the investigators. “MRA [mineralocorticoid receptor antagonist] treatment should be considered in all patients with HFrEF, regardless of the duration of HF.”

Disclosure: The EMPHASIS-HF trial was sponsored by Pfizer. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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As a highly marginalized group, transgender and gender-diverse individuals experience disproportionate rates of depression, anxiety, and suicidality. Previous cross-sectional and uncontrolled studies have reported decreased gender dysphoria and depression upon initiation of gender-affirming hormone therapy. However, these links lack data from randomized clinical trials.

In a 3-month, open-label randomized clinical trial (ANZCTR.org.au Identifier: ACTRN1262100016864), researchers recruited transgender and gender-diverse individuals (N=62) seeking testosterone therapy in Australia between 2021 and 2022. Participants were randomized to receive either immediate initiation of testosterone (n=31) or standard care with a 3-month wait before initiation (n=31). Testosterone was administered as either intramuscular 1000 mg undecanoate injections at weeks 0 and 6 or transdermal 1% gel 4 pump daily actuation, per participant choice.

The primary outcome was gender dysphoria according to the Gender Preoccupation and Stability Questionnaire (GPSQ). Secondary outcomes were depression according to the Patient Health Questionnaire-9 (PHQ-9) and suicidality according to Suicidal Ideation Attributes Scale (SIDAS).

Among the immediate and standard treatment groups, the median ages were 23 (interquartile range [IQR], 20-28) and 22 (IQR, 20-27) years, respectively. The proportion of participants with depression and anxiety were 74% and 65% in the immediate treatment group and 58% and 65% in the standard treatment group, respectively.

At baseline, mean testosterone levels among the immediate and standard treatment groups were 37.5 (SD, 20.2) and 25.9 (SD, 14.4) ng/dL, respectively. At 3 months, the immediate treatment group had an average testosterone level of 391.9 (SD, 239.2) ng/dL.

Among the immediate and standard treatment groups, 19 and 18 chose intramuscular and 12 and 13 chose transdermal routes, respectively.

From baseline to month 3, the individuals who received immediate testosterone therapy, compared with those who received standard care, had significant reductions in gender dysphoria, depression, and suicidality outcomes. The immediate testosterone group had decreases in scores of:

• GPSQ (-7.2; 95% CI, -8.3 to -6.1; P <.001);
• PHQ-9 (-5.6; 95% CI, -6.8 to -4.4; P <.001); and,
• SIDAS (-6.5; 95% CI, -8.2 to -4.8; P <.001).

Adverse events included 7 individuals who reported injection site pain or discomfort and 1 individual who reported a transient headache 24 hours after intramuscular injection.

Study limitations were the short follow-up duration of 3 months, the lack of participant blinding to intervention group, and the fact that the GPSQ has not been validated to measure longitudinal changes in gender dysphoria.

“This open-labeled randomized clinical trial supports the use of testosterone therapy to significantly reduce gender dysphoria, depression, and suicidality in transgender and gender-diverse adults desiring commencement of testosterone therapy,” the researchers concluded. “These findings have critical implications for service access and delivery to ensure timely access to gender-affirming hormone therapy.”

Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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In intention-to-treat analyses, patients undergoing thrice-weekly extended HHD had a significant 40% lower risk for all-cause mortality in adjusted analyses compared with those receiving ICHD, Ercan Ok, MD, of Ege University School of Medicine in Izmir, Turkey, and colleagues reported in Kidney International Reports.

For the study, Dr Ok’s team propensity-score matched 349 patients starting thrice-weekly extended HHD with 1047 patients concurrently receiving ICHD. The mean durations of dialysis sessions were 418 minutes in the extended HHD group compared with 242 minutes in the ICHD group. The all-cause mortality rates in the extended HHD and ICHD groups were 3.76 and 6.27 per 100 patient-years, respectively, a significant difference between the groups.

In addition, extended HHD significantly improved phosphate and blood pressure control and significantly reduced the hospitalization rate compared with ICHD, according to the investigators.

In intention-to-treat analyses, the median follow-up duration for the HHD and ICHD groups was 55.4 and 54.8 months, respectively. Overall survival rates at the end of follow-up were 79.3% in the HHD group and 59.1% in the ICHD group.

Disclosure: Some study authors declared affiliations with FMC Turkey and biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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 MetS, an increasingly common syndrome that has been identified as a risk factor in cardiovascular disease and diabetes, comprises a group of interrelated conditions that include hypertension, dyslipidaemia, central obesity, and insulin resistance. Investigators sought to determine if risk for lung cancer is associated with MetS and its components, evaluating the possibility of effect modification by sex, smoking status, and medication use.

The investigators conducted a population-based prospective cohort study of individuals from the United Kingdom (UK) Biobank, a prospective cohort of more than half a million women and men, aged 37 to 73 years, recruited between 2006 to 2010 from 22 assessment centers across England, Scotland, and Wales. Among the more than 331,000 participants in the current analysis, 77,173 had MetS upon study enrollment. All participants were followed (median 10.9 years) for incidence of cancer through February 2020 in England and Wales, and through January 2021 in Scotland.

The researchers divided patients into cohorts with and without MetS; both groups had similar demographics with respect to age, sex, race, and the number of individuals who smoked/never smoked. Significantly greater proportions of individuals with vs without MetS were noted in subgroups related to obesity (60% vs 13%, respectively), antihypertensives (39% vs 18%, respectively), and lipid lowering medication (31% vs 14%, respectively).

Among the 2425 participants who developed lung cancer (with the lung as the primary cancer site), MetS was found to be a statistically significant risk factor. The hazard ratios (HRs) noted for MetS and lung cancer risk were as follows: overall lung cancer HR, 1.21 (95% CI, 1.09-1.33; adenocarcinoma HR, 1.28 (95% CI, 1.10-1.50); squamous cell carcinomaHR, 1.16 (95% CI, 0.94-1.44). The study authors noted HRs increased with the number of metabolic abnormalities, from 1.11 to approximately 1.4 to 1.5 among those with 1 to 5 disorders.

Positive associations with lung cancer were found among individuals with MetS subcomponents, including hyperglycemia (HR, 1.30; 95% CI, 1.16-1.45), elevated waist circumference (HR, 1.36; 95% CI, 1.22-1.53), and low high-density lipoprotein cholesterol (HDL-C)(HR, 1.20; 95% CI, 1.09-1.32). The investigators noted lung cancer incidence rates were higher among individuals in all MetS subcomponent subgroups, with an especially high incidence rate among those with vs without hyperglycemia (141.4/100,000 vs  64.1/100,000, respectively).

Female sex had the strongest modification effect on the relationship between MetS and lung cancer. Women vs men with MetS had higher lung cancer risk (HR, 1.38; 95% CI, 1.20-1.60 vs HR, 1.07; 95% CI, 0.93-1.23; P =.031). Among women with 5 metabolic abnormalities, risk of lung cancer was double that of women with no abnormalities. For men, having a greater number of metabolic abnormalities did not result in any kind of statistically significant trend with respect to lung cancer.

The modification effect of smoking upon risk for lung cancer due to MetS was not statistically significant, although lung cancer risk due to MetS was mostly elevated among smokers. A non-linear association existed between lung cancer and glycated hemoglobin, waist circumference, and HDL-C.

Study limitations include residual confounding and inconsistencies in biomarker measurements due to the use of non-fasting baseline blood samples.

The investigators concluded, “In this study, we found associations of MetS and its components with increased risk of lung cancer. This relationship could potentially be modified by sex and smoking.” The study authors added, “Although a causal association between MetS and lung cancer cannot be verified through this study, the evidence obtained suggests the importance of taking metabolic status and markers into the selection of high-risk populations for lung cancer screening, and highlights a new direction of lung cancer prevention.”

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Abrysvo

Abrysvo is an unadjuvanted bivalent vaccine containing recombinant RSV prefusion F (preF) A and RSV preF B. The approval for maternal immunization was based on data from the phase 3 MATISSE trial (ClinicalTrials.gov Identifier: NCT04424316).

“This is another new tool we can use this fall and winter to help protect lives,” said CDC Director Dr. Mandy Cohen. “I encourage parents to talk to their doctors about how to protect their little ones against serious RSV illness, using either a vaccine given during pregnancy, or an RSV immunization given to your baby after birth.”

Abrysvo is currently available in a kit containing a vial of lyophilized antigen component, a prefilled syringe containing diluent and a vial adapter. Prior to intramuscular administration, the lyophilized antigen component should be reconstituted with the sterile water diluent component.

Abrysvo is also indicated for the prevention of LRTD caused by RSV in individuals 60 years of age and older. 

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Researchers found that, among cancer patients with private insurance, those living in states that did not provide coverage parity or payment parity were less likely to use telehealth in the first year of the COVID-19 pandemic.

The study included 53,982 patients who were diagnosed with breast cancer (33.3%), prostate cancer (28.9%), lung cancer (16.8%), colorectal cancer (12.3%), or lymphoma (8.7%) between March 2020 and March 2021.

Most of these patients (76.1%) had Medicare Advantage. Among patients who had private insurance, 11.0% lived in a state with telehealth coverage and payment parity, 7.4% lived in a state with coverage parity only, and 5.4% lived in a state with no or unspecified telehealth parity laws.

Most patients (70.6%) lived in states that allowed cross-state telehealth, but 29.4% lived in states with policies limiting cross-state telehealth.

In a multivariable analysis, several factors were associated with lower odds of using telehealth, including:

• Having private insurance and living in a state with coverage parity alone (vs both coverage and payment parity; odds ratio [OR], 0.82; 95% CI, 0.74-0.92; P =.001)
• Having private insurance and living in a state with no or unspecified telehealth parity laws (OR, 0.77; 95% CI, 0.70-0.85; P <.001)
• Having Medicare Advantage (OR, 0.59; 95% CI, 0.54-0.65; P <.001)
• Living in a state with limitations on cross-state telehealth (OR, 0.80; 95% CI, 0.76-0.85; P <.001)
• Having colorectal cancer (vs breast cancer; OR, 0.90; 95% CI, 0.84-0.97; P =.007)
• Being non-Hispanic Black (vs non-Hispanic White; OR, 0.83; 95% CI, 0.76-0.91; P <.001)
• Being 50-64 years of age (OR, 0.70; 95% CI, 0.64-0.77; P <.001), 65-74 years of age (OR, 0.67; 95% CI, 0.60-0.74; P <.001), or 75 years of age or older (OR, 0.61; 95% CI, 0.55-0.69; P <.001).

Patients diagnosed with cancer from May 2020 through March 2021 also had lower odds of using telehealth than patients diagnosed in March 2020 (P =.032 for May 2020; P <.001 for all other months).

The researchers noted that, despite having telehealth coverage, patients with Medicare Advantage were less likely to use telehealth than patients with private insurance. The researchers speculated that this could be related to patient or provider preferences, complexity of care, digital literacy or comfort with technology, access to digital technology, or reliable internet access.

When the researchers looked only at patients who were younger than 65 years of age and had private insurance, the results were similar to those seen in the overall population.

“Telehealth use by patients diagnosed with cancer during the pandemic was higher among those living in states with more generous parity and less restrictive rules for cross-state practice,” the researchers concluded. “Policy makers contemplating whether to permanently relax certain telehealth policies must consider the impact on vulnerable patient populations who can benefit from telehealth.”

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Researchers conducted a meta-analysis using individual participant data from 3 long-term, placebo-controlled, double-blind, randomized clinical trials (CONFIRM-HF, AFFIRM-AHF, and HEART-FID). The trials included adult patients with HF and iron deficiency, used FCM as an active treatment for iron deficiency, had 52 weeks or longer of follow-up, and prospectively reported outcomes including first and recurrent HF and CV hospitalizations, CV death, and all-cause death. A systematic review was performed in PubMed for trials published between July 19, 2013, and July 18, 2023, and the results of the IRONMAN trial were included in a sensitivity analysis.

The prespecified coprimary efficacy endpoints were a composite of recurrent CV hospitalizations and death for any CV reason and a composite of recurrent HF hospitalizations and CV death at 52 weeks.

The 3 trials randomly assigned 4501 patients to receive FCM (n=2251) or placebo (n=2250). The cohort had a mean age of 69.2 (SD 11.0) years, a mean LVEF of 31.6% (SD 8.1%), and 63% were men.

FCM therapy significantly decreased the coprimary composite endpoint of CV death and total CV hospitalizations vs placebo (rate ratio [RR], 0.86; 95% CI, 0.75-0.98; P =.029), without evidence of trial heterogeneity. A similar trend toward a decrease of the coprimary composite endpoint of CV death and total HF hospitalizations also was observed (RR, 0.87; 95% CI, 0.75-1.01; P =.076), without evidence of trial heterogeneity.

FCM therapy was associated with a 17% relative rate reduction in total CV hospitalizations (RR, 0.83; 95% CI, 0.73-0.96; P =.009) as well as a 16% relative rate reduction in total HF hospitalizations (RR, 0.84; 95% CI, 0.71-0.98; P =.025). FCM therapy did not affect the time to CV death (hazard ratio [HR], 0.97; 95% CI, 0.80-1.17; P =.72).

In subanalyses, evidence was observed for a significant interaction between transferrin saturation (TSAT) and the composite of CV hospitalization and CV death (P_interaction =.019) and for CV death (P_interaction =.035). Participants in the lowest TSAT tertile (<15%) had a greater treatment effect compared with those who had a higher baseline TSAT. A similar pattern occurred regarding the effect of TSAT on total HF hospitalizations and CV death (P_interaction =.095).

FCM therapy was associated with a decreased time to first CV death or HF hospitalization by 12% (HR, 0.88; 95% CI, 0.78-0.99; P =.039) as well as the time to first CV death or CV hospitalization by 11% (HR, 0.89; 95% CI, 0.80-0.99; P =.033).

The FCM and placebo groups had rates of serious treatment-emergent infections of 9.9 per 100 patient-years and 9.6 per 100 patient-years, respectively. No deaths were reported as resulting from serious treatment-related treatment-emergent adverse events.

Among several limitations, the researchers did not have access to the individual participant data from the IRONMAN trial, and the follow-up was limited to 12 months in the main analyses. “Importantly, our findings support continued research to identify those patients who are most likely to benefit from treatment with intravenous iron, particularly as it relates to the criteria used to identity ID [iron deficiency] and eligibility for initial and repeat iron doses,” the investigators wrote.

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Previous comparisons of sacubitril/valsartan and olmesartan for the treatment of hypertension produced inconsistent results regarding effectiveness, which led investigators of the current study to compare the efficacy and safety of sacubitril/valsartan and olmesartan for the treatment of hypertension.

The investigators systematically searched the Cochrane Library, Embase, Web of Science, ClinicalTrials.gov, and PubMed databases through mid-November 2022 for randomized controlled trials, in which sacubitril/valsartan was administered to the experimental group and olmesartan administered to the control group to study their effects on blood pressure control, with recognized statistical significance with P values less than 0.05.

The review authors included 6 studies (N=4127 patients) among whom 2497 patients were treated with sacubitril/valsartan (83.8% Asian patients) and 1630 patients were treated with olmesartan (76.5% Asian patients). Included studies were all judged as high-quality by the Cochrane Collaboration tool for risk of bias, and the Egger test showed no significant publication bias.

The investigators found that sacubitril/valsartan vs olmesartan significantly decreased mean sitting systolic and diastolic blood pressure and sitting pulse pressure, as well as 24-hour ambulatory systolic and diastolic blood pressure. For different doses of sacubitril/valsartan, analysis of the antihypertensive effects showed mean ambulatory systolic blood pressure (maSBP) and mean ambulatory diastolic blood pressure were significantly reduced with sacubitril/valsartan 200 mg/d and 400 mg/d, although heterogeneity was very high among the studies showing maSBP.

Occurrence of the majority of adverse events (including nausea, back pain, abdominal pain, respiratory tract infection, and dizziness) showed no significant difference between sacubitril/valsartan and olmesartan. A decreased probability of headache was noted in patients treated with sacubitril/valsartan. Serious adverse events (including stroke, intracranial hemorrhage, coronary disease, and arrhythmia) were more effectively reduced with sacubitril/valsartan 400 mg/d than with olmesartan according to subgroup analysis.

Sensitivity analysis (using 1-by-1 elimination) showed no significant changes in the outcome indicators with relatively low heterogeneity.

Limitations of the study include the underpowered sample size for the verification of therapeutic effects comparison at different doses, the long-term antihypertensive effect of sacubitril/valsartan is not explained, and the inability to determine long-term side effects.

“Sacubitril/valsartan was better than olmesartan in controlling blood pressure in patients with hypertension, with relatively higher safety,” the investigators wrote. “The antihypertensive effect of LCZ696 [sacubitril/valsartan] was greater than that of olmesartan. According to the subgroup analysis, the antihypertensive effect of LCZ696 was directly related to the dose.”

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Betaxolol is a β1-selective adrenergic receptor blocking agent indicated for the management of hypertension. According to the Company, the affected product (NDC 10702-013-01; Lot 17853A; Expiration date June 2027), which was distributed to retail pharmacies, is being recalled out of an abundance of caution. 

Because the Betaxolol 10mg tablet and the Oxycodone 5mg tablet have a similar appearance, it is unlikely a regular user would be able to distinguish between them. The Betaxolol 10mg tablet has an imprint code of “K” and “13”, while the Oxycodone HCl 5mg tablet has an imprint code of “K” and “18”; both tablets are round and white.

Consumers who may have received the affected product should discontinue use immediately. Inadvertent administration of oxycodone HCl, an opioid agonist, may pose a significant health risk to certain individuals, including those with opioid use disorder, as well as patients with compromised heart and lung function. 

To date, the Company has not received any reports of foreign tablets in any bottle of Betaxolol 10mg Tablets. Adverse events and quality issues should be reported to the FDA’s MedWatch program.

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In May 2021, the FDA approved Empaveli, a complement inhibitor, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). The new Empaveli Injector is designed to offer greater mobility for patients during administration; it is for abdominal subcutaneous use only.

The device includes a push button to initiate the injection and a hidden needle which automatically retracts upon dose completion. Injection time is approximately 30 to 60 minutes. 

“Empaveli continues to demonstrate its potential to elevate the standard of care, including rapid and sustained improvements of PNH disease measures,”  said Peter Hillmen, MB ChB, PhD, head, rare disease advisor, Apellis. “Now, we are further enhancing the patient experience with the approval of the Empaveli Injector, an innovative and first-of-its-kind, high-volume injector.”

The Empaveli Injector is expected to be available by the end of October 2023.

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The approval was based on data from the phase 3 EMPA-KIDNEY trial (ClinicalTrials.gov Identifier: NCT03594110), which included 6609 adults with CKD (eGFR ≥20 to <45mL/min/1.73 m²; or eGFR ≥45 to <90mL/min/1.73 m² with urine albumin to creatinine ratio [UACR] ≥200mg/g). Approximately 44% of the study population had type 2 diabetes. 

Patients were randomly assigned to receive empagliflozin 10mg or placebo once daily, in addition to standard of care. The primary composite endpoint was the time to first occurrence of kidney disease progression (defined as end stage kidney disease with a sustained decline in eGFR <10mL/min/1.73m², renal death, or a sustained decline of ≥40% in eGFR) or CV death.

Findings showed that treatment with empagliflozin met the primary endpoint reducing the risk of kidney disease progression or CV death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.64-0.82; P <.0001); results were generally consistent across prespecified subgroups, including eGFR categories, underlying cause of kidney disease, diabetes status, and background use of renin-angiotensin system inhibitors. Empagliflozin was also associated with a 14% reduction in the risk of first and recurrent hospitalization compared with placebo (HR, 0.86; 95% CI, 0.78-0.95; P =.0025).

“This approval provides health care professionals in the US with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations,” said Katherine Tuttle, MD, Executive Director for Research, Providence Inland Northwest Health, Regional Principal investigator for the Institute of Translational Health Sciences and Professor of Medicine at the University of Washington, and EMPA-KIDNEY steering committee member. “The meaningful benefits that empagliflozin demonstrated in the EMPA-KIDNEY phase 3 trial are welcome news for adults living with CKD in this country.”

Jardiance is not recommended for the treatment of CKD in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45mg of prednisone or equivalent for kidney disease. It is not expected to be effective in these populations.

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Researchers evaluated adverse events associated with PJP prophylaxis and assessed PJP incidence among patients receiving treatment for AAV.

Data were taken from the TriNetX electronic health records database, comprised of information from 72 healthcare organizations. Patients with diagnostic-confirmed AAV who received at least one administration of rituximab or cyclophosphamide were included in the analysis. Incidence of PJP within 6 months of treatment initiation was the primary endpoint. Adverse events occurring within the 6-month period following treatment initiation were evaluated.

A total of 1461 patients with AAV were included in the analysis. Mean patient age was 56.2 years, 59.8% of patients were women, and 73.0% were White. Rituximab was most commonly used for induction therapy (69.7%).

Overall, 37.1% of patients received PJP prophylaxis within the first 30 days of induction therapy, with trimethoprim-sulfamethoxazole (30.7%) being most commonly used.

During the 6 months following treatment initiation, 10 cases of PJP occurred, corresponding to an incidence rate (IR) of 15.0 cases/1000 patient-years. No deaths occurred during this period.

A total of 709 patients were included in a subset analysis investigating rituximab maintenance therapy. An additional 5 cases of PJP were identified during this period, corresponding to an IR of 2.11 cases/1000 patient-years. One patient died while hospitalized with PJP.

Patients receiving vs not receiving prophylaxis were at greater risk for rash (hazard ratio [HR], 1.9; 95% CI, 1.0-3.6), nephropathy (HR, 2.6; 95% CI, 1.3-5.1), and leukopenia (HR, 3.1; 95% CI, 1.1-8.6), according to adjusted analyses.

Study limitations included potential missed diagnoses of PJP and under/miscoding of PJP and adverse events. Additionally, data on prophylaxis medication adherence was unknown. 

The study authors stated, “This study identified a lower incidence of PJP than previously observed.”

“Taken together, our study and similar recent real-world evaluations suggest that PJP may be less common among patients with AAV than previously assumed,” they concluded.  

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Influenza infections have been associated with higher rates of myocardial infarction (MI) and heart failure (HF). To mitigate this associated risk, the INVESTED (Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure; ClinicalTrials.gov Identifier: NCT02787044) trial investigated whether a high-dose influenza vaccine may lower cardiopulmonary event rates during influenza season.

The INVESTED study was a randomized, double-blind, active comparator trial conducted at 157 sites in the United States and Canada between 2016 and 2019. Patients (N=5260) with high-risk cardiovascular disease (CVD) who had been hospitalized in the past 12 months for MI or in the past 24 months for HF were randomly assigned to receive a high-dose trivalent (n=1548) or standard-dose quadrivalent (n=1546) influenza vaccine. In this secondary analysis of the INVESTED trial data, the primary outcome was to evaluate whether the high-dose vaccine was associated with decreased cardiopulmonary event risk.

The high- and standard-dose recipients had mean ages of 65 (SD, 13) and 67 (SD, 13) years, 74.4% and 74.8% were men, 73.0% and 71.8% were White, they had BMI of 31.9 (SD, 8.1) and 31.7 (SD, 7.7), and they had ejection fraction of 41% (SD, 17%) and 42% (SD, 16%), respectively.

When there was a 1% increase in influenza-like illness activity in the prior week, risk for the composite outcome of cardiopulmonary hospitalizations and all-cause mortality was increased (adjusted odds ratio [aOR], 1.14; 95% CI, 1.07-1.21; P <.001). Similarly, higher influenza-like illness activity associated with elevated risk for cardiopulmonary hospitalizations (aOR, 1.13; 95% CI, 1.06-1.21; P <.001) and cardiovascular hospitalizations (aOR, 1.12; 95% CI, 1.04-1.19; P =.001). Influenza activity was not significantly related to risk for pulmonary hospitalizations (aOR, 1.18; 95% CI, 0.99-1.40; P =.06) or all-cause mortality (aOR, 1.00; 95% CI, 0.88-1.13; P >.99).

Stratified by vaccine dose, the high-dose vaccine did not associate with decreased risk for the primary composite outcome relative to the standard dose (aOR, 1.07; 95% CI, 0.95-1.20; P =.25). Similarly, no trends were observed in months with typically high influenza activity (aOR, 1.09; 95% CI, 0.97-1.24; P =.15) or during weeks with high influenza-like illness activity (aOR, 0.88; 95% CI, 0.65-1.20; P =.43).

These findings may be limited, as patient-level influenza infection data were not collected in INVESTED.

 “…influenza activity was temporally associated with an increasing risk of [cardiopulmonary] events, yet a higher-dose influenza vaccine did not significantly reduce temporal CV risk,” the study authors wrote. “Other seasonal factors may also play a role in the higher rate of CV events associated with high rates of influenza.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Researchers conducted a systematic review and meta-analysis to evaluate the dose-response association of objectively measured step count metrics with all-cause mortality and incident CVD in the general population.

A literature search was performed in PubMed and EMBASE from inception to October 2022. Eligible studies quantified daily step count with objective step-counting methods, evaluated the associations between step count and all-cause mortality or incident fatal or nonfatal CVD, had a prospective cohort design, were peer reviewed and published online in English, and included adults aged 18 years or older without CVD at baseline.

The analysis included 12 studies: 11 studies assessed the association between step count and all-cause mortality (n=111,309; 60.8% women; mean age, 62.5±5.3 years), 4 studies assessed step count and incident CVD (n=85,261), and 4 assessed step cadence and all-cause mortality (n=102,191).

Overall, 4854 (4.4%) participants died during a median follow-up of 77.8 months, and 1224 individuals (1.4%) had CVD events during 72.9 months of follow-up.

Continuous dose-response analyses demonstrated nonlinear trends (P for nonlinearity <.001) for associations between step count vs all-cause mortality and incident CVD. Decreases in risk were statistically significant for the associations with all-cause mortality and CVD at 2517 steps/day (adjusted hazard ratio [aHR], 0.92; 95% CI, 0.84-0.999) and 2735 steps/day (aHR, 0.89; 95% CI, 0.79-0.999), respectively.

For all-cause mortality and CVD, the minimal effective step count was 479 steps/day and 735 steps/day greater than the reference category for other cutoff points. Additional step count increases were associated with reduced mortality and CVD risk until 8763 steps/day (aHR, 0.40; 95% CI, 0.38-0.43) and 7126 steps/day (aHR, 0.49; 95% CI, 0.45-0.55), after which additional decreases in mortality and incident CVD risk were not statistically significant (16,000 vs 2,000 steps/day: aHRs, 0.35 [95% CI, 0.30-0.40] and 0.42 [95% CI, 0.33-0.53], respectively).

Cadences considered intermediate (median, 63 steps/min) and high (median, 88 steps/min) were associated with a decreased mortality risk (aHRs, 0.67 [95% CI, 0.56-0.80] and 0.62 [95% CI, 0.40-0.97]) compared with a low cadence (median, 29 steps/min). Further adjustments in step count reduced these associations for intermediate cadence (aHR, 0.78; 95% CI, 0.65-0.93) and high cadence (aHR, 0.79; 95% CI, 0.67-0.94).

Limitations of the study include the evaluation of daily step counts only at baseline and the inability to quantify the effects of reverse causation and other relevant factors that influence daily step count. In addition, only 4 studies assessed the additional effects of step cadence to total step count, and the findings may not apply to chronically diseased, older, and low-income populations.

“As health benefits of daily steps were similar between men and women and step count targets were independent of wear location and device, the integration of uniform daily step targets in future physical activity guidelines may be relevant from a public health perspective, as ‘every step counts,’” wrote the study authors.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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