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 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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Rebecca A. Gourevitch, Ph.D., from the University of Maryland in College Park, and colleagues used results from a multistate survey to examine variation in prenatal telehealth use and reasons for its nonuse at the height of the COVID-19 pandemic. The analysis included responses from 12,073 participants in the 2020 Pregnancy Risk Assessment Monitoring System who gave birth between June and December 2020.

The researchers found that one in three respondents used prenatal telehealth. Use was similar for respondents with private insurance and Medicaid, but uninsured respondents were 14.6 percentage points less likely to use prenatal telehealth. Compared with non-Hispanic White respondents, Hispanic, Asian or Pacific Islander, and Indigenous respondents were more likely to use prenatal telehealth, while participants in rural areas were less likely to use it than urban respondents. Among the 7,686 respondents who did not use prenatal telehealth, personal preference for in-person care (70 percent) was the most reported reason, followed by no appointment availability (26 percent), other reasons (14 percent), and technological barriers (5 percent).

“Our results by insurance type and race and ethnicity are more consistent with national surveys across conditions than with single-site studies of prenatal telehealth, highlighting the importance of multisite research to inform best practices,” the authors write.

Abstract/Full Text

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Michelle H. Moniz, M.D., from the University of Michigan in Ann Arbor, and colleagues evaluated the association between childbirth and having medical debt in collections. Differences were examined by neighborhood socioeconomic status. The analysis included a statewide cohort of commercially insured pregnant (14,560 individuals) and postpartum (12,157 individuals) adults.

The researchers found that having medical debt in collections was more likely among postpartum individuals versus pregnant individuals (adjusted odds ratio, 1.36) and among those in lowest-income neighborhoods versus all others (adjusted odds ratio, 2.18). The highest predicted probabilities of having medical debt in collections was seen among postpartum individuals in the lowest-income neighborhoods (28.9 percent), followed by pregnant individuals in the lowest-income neighborhoods (23.2 percent), and all other postpartum and pregnant people (16.1 and 12.5 percent, respectively).

“Policies to reduce maternal-infant health care spending among commercially insured individuals may mitigate financial hardship and improve birth equity,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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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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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.

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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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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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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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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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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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Annette K. Regan, Ph.D., from Curtin University in Perth, Australia, and colleagues conducted a population-based cohort study of 279,418 mother-infant pairs to estimate maternal vaccine effectiveness (VE) and whether maternal pertussis vaccination modifies the effectiveness of the first three infant doses of pertussis-containing vaccines.

The researchers found that pertussis was administered during 51.7 percent of pregnancies, mainly at 28 to 31 weeks of gestation. There was a decline seen in VE of maternal vaccination from 70.4 to 43.3 percent among infants younger than 2 months old versus those aged 7 to 8 months; VE was not significant after 8 months of age. Slightly lower VE point estimates were seen for the third dose of infant pertussis vaccine among maternally vaccinated versus unvaccinated infants (76.5 versus 92.9 percent), but the rates of pertussis infection were not higher.

“These results indicate that maternal pertussis vaccination protects infants from pertussis infection during a period of greatest vulnerability to severe morbidity and mortality,” the authors write. “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

Abstract/Full Text

Editorial

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Marcus V. Ortega, M.D., from Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues examined the prevalence of burnout among physicians in a large multispecialty group over a five-year period. Analysis included 1,373 physician faculty members of the Massachusetts General Physicians Organization surveyed in 2017, 2019, and 2021. Different clinical specialties and a full range of career stages were represented in the group of physicians.

The researchers found that 50.3 percent of the respondents were men, 67.1 percent were White, and 34.8 percent reported between 11 and 20 years of experience. Burnout in the group reporting between 11 and 20 years of experience declined from 44.4 percent in 2017 to 41.9 percent in 2019, but increased to 50.4 percent in 2021. Significantly higher burnout rates were seen among female physicians versus their male counterparts, primary care physicians versus physicians in other specialties, and physicians with ≤10 years of experience versus those with more experience.

“The findings of this survey study suggest that the physician burnout rate in the U.S. is increasing,” the authors write. “This pattern represents a potential threat to the ability of the U.S. health care system to care for patients and needs urgent solutions.”

Abstract/Full Text

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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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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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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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Claire N. Shappell, M.D., M.P.H., from Harvard Medical School/Harvard Pilgrim Health Care Institute in Boston, and colleagues conducted a retrospective cohort study of adults hospitalized at five Massachusetts hospitals between March 2020 and November 2022 to describe trends in the quarterly incidence and in-hospital mortality for SARS-CoV-2-associated and presumed bacterial sepsis.

Data were included for 431,017 hospital encounters from 261,595 individuals. Of these, 5.4 percent were from SARS-CoV-2, 1.5 percent had SARS-CoV-2-associated sepsis, and 7.1 percent had presumed bacterial sepsis without SARS-CoV-2 infection. The researchers found a decline in the crude in-hospital mortality for SARS-CoV-2-associated sepsis from 33.4 to 14.9 percent in the first and last quarter (adjusted odds ratio, 0.88 per quarter). For presumed bacterial sepsis, crude mortality was 14.5 percent and was stable across quarters. Electronic health record (EHR)-based SARS-CoV-2-associated sepsis criteria performed well relative to sepsis-3 criteria on medical record reviews of 200 SARS-CoV-2-positive hospitalizations (sensitivity, 90.6 percent; specificity, 91.2 percent).

“These findings highlight the high burden of SARS-CoV-2-associated sepsis and demonstrate the feasibility of using EHR-based algorithms to conduct surveillance for viral sepsis,” the authors write.

One author disclosed ties to UpToDate and Cytovale.

Abstract/Full Text

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Neal G. Ravindra, Ph.D., from the Stanford School of Medicine in California, and colleagues used physical activity data from a wearable device, including more than 181,944 hours of data from 1,083 participants, to examine associations between physical activity and sleep patterns during pregnancy and PTB. A “clock” of healthy dynamics during pregnancy using gestational age as a surrogate for progression of pregnancy was developed using a new deep learning time-series classification architecture. Novel interpretability algorithms that integrate unsupervised clustering, model error analysis, feature attribution, and automated actigraphy analysis were developed, allowing for model interpretation with respect to sleep, activity, and clinical variables.

The researchers found that for modeling the progression of pregnancy, the model performed better than seven other machine learning and artificial intelligence methods. There was a strong association seen for deviations from a normal “clock” of physical activity and sleep changes during pregnancy with pregnancy outcomes. There were 0.52 fewer PTBs than expected and 1.44 more PTBs than expected when the model underestimated and overestimated gestational age, respectively. There was a negative correlation observed for model error with interdaily stability, indicating that when the daily rhythms were less precise, the model assigned a more advanced gestational age.

“This is exciting preliminary data,” coauthor Nima Aghaeepour, Ph.D., from Stanford University, said in a statement. “The results suggest that scientists should run studies to test whether tracking and modifying pregnant women’s sleep or physical activity could their lower prematurity risk.”

Abstract/Full Text

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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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That issue is “largely, if not completely,” resolved after U.S. Health and Human Services Secretary Xavier Becerra met with CVS Health, UnitedHealth Group, Anthem, and Cigna, agency spokesperson Jeff Nesbit told NBC News. The companies are “fully covering the new vaccine shots,” the HHS stated, which added the problems were due to “systemic technical issues.”

More than 2 million people had already received the updated vaccines by Wednesday, according to HHS.

The federal government is no longer paying for the vaccines, but instead asking they be covered by insurance companies. The insurance companies said they planned to monitor reports of “technical or coding barriers to vaccine coverage,” according to a letter shared with NBC News from an industry trade group.

Aetna said it will treat the COVID-19 vaccine like an annual flu shot, allowing members to get the vaccines in the same locations, NBC News reported.

The new boosters were approved by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention earlier this month.

NBC News Article

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In the first trial, clinicians in the active intervention arm had to either order a non-steroidal anti-inflammatory drug (NSAID) or acknowledge that the patient had a contraindication to the use of an NSAID. This group of clinicians was compared with a control group who were able to skip this step in the pain management protocol.

In the second trial, in the active intervention arm, NSAIDs were preordered by being prechecked on the electronic order form and clinicians were rerandomized.

Throughout both trials, acetaminophen was preordered for all groups and clinicians could reverse the orders for acetaminophen or NSAIDs and bypass the use of pain medication for patients with no greater than mild pain.

The researchers then did an interrupted time series analysis of all adults admitted after a surgical procedure since January 1, 2020, to determine changes over time in the ordering of acetaminophen and NSAIDs by the end of the first full day spent in the hospital and in opioid prescribing at discharge.

During each period, for each group, and overall, they used a logistic model with time as the only independent variable and plotted the model predictions as the best fit line. They then tested the null hypothesis that the likelihood of the outcome at the end of the intervention period was equal to the likelihood of the outcome immediately before the first trial.

The study, which evaluated 18143 encounters and randomly assigned 1176 clinicians, revealed that acetaminophen use increased after preordering of the drug began.

During the first trial, NSAID prescribing was no different for clinicians using the standard orders than for those using the orders that required NSAIDs.

During the second trial, NSAID prescribing was substantially higher when the drug was preordered compared with when NSAIDs were the required choice. Opioid use was more common when NSAIDs were preordered, but opioid use at discharge began to decrease.

No difference in the adverse effects of NSAIDs, such as new gastrointestinal bleeding, new acute kidney injury, or death, was found between groups in either trial. However, ordering of acetaminophen increased in the group with mild pain.

The generalizability of the study is limited because it was conducted at a single institution.

The researchers drew the following conclusions from the study results: “We found that prechecking orders at admission for surgical patients for both acetaminophen and NSAIDs increased ordering of these multimodal pain regimens. However, the rate of NSAID use remained low, perhaps representing clinician resistance to its use postoperatively despite studies showing its safety.”

“Opioid prescribing at discharge appeared to decrease, likely due to multiple concomitant institution-wide campaigns to standardize opioid prescribing. However, the fact that acetaminophen [use] rose in all groups, including the mild pain group, suggests a learning effect from the intervention on clinician ordering overall, not just when orders are prechecked.”

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“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” FDA Commissioner Robert Califf, M.D., explained in an agency news release.

Some more common tests — such as those used in hospitals, pharmacies, or doctors’ offices to spot strep throat, COVID-19, and other conditions — are already subject to premarketing FDA review. But thousands of so-called “laboratory developed tests” (LDTs), analyzed at many high-tech labs, face no FDA oversight. These tests are often highly sophisticated and are used to identify cancers, sexually transmitted infections, and a host of other conditions.

“In the 1970s and 1980s, many LDTs were lower risk, small volume, and used for specialized needs of a local patient population,” the FDA explained. “Since then, due to changes in business practices and increasing ability to ship patient specimens across the country quickly, many LDTs are now used more widely, for a larger and more diverse population, with large laboratories accepting specimens from across the country. LDTs are also increasingly relying on high-tech instrumentation and software, being performed in large volumes and being used more frequently to help guide critical health care decisions.”

Beyond that, some companies are now pitching their tests directly to consumers, the FDA noted. At the same time, reports of problematic tests have increased. Inaccurate test results can lead to devastating consequences for patients. “The FDA is concerned patients could initiate unnecessary treatment, or delay or forgo proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death,” the agency warned.

The FDA says the new oversight will be phased in gradually over the next few years to avoid “undue disruption to the testing market.” The agency claims that the new regulations will be a net cost benefit due to “a reduction in health care costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims and from therapeutic decisions based on the results of those tests.”

The FDA is taking comments on the new proposals over the next 60 days.

More Information

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Alessandro Di Nallo, Ph.D., from Bocconi University in Milan, and Selin Köksal, from the University of Essex in Colchester, England, used data from a longitudinal survey that interviewed a representative sample of households living in the United Kingdom annually since 2009 to examine whether exposure to job loss during pregnancy increases the risk for miscarriage or stillbirth. The final sample included 8,142 pregnancy episodes with complete information on pregnancy outcome and date of conception.

The researchers observed an estimated increased risk for pregnancy loss when women were exposed to their own or their partner’s job loss during their pregnancy (odds ratio, 1.99) in baseline models controlling for women’s demographic background and prior experience of miscarriage. The association remained robust when the models were adjusted for all socioeconomic and partnership-related covariates (odds ratio, 1.81).

“Our findings are important as we uncover a potential socioeconomic, hence preventable, factor behind pregnancy losses that can be addressed through effective policymaking,” Köskal said in a statement.

Abstract/Full Text

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Researchers conducted a cohort study from July 2020 to June 2022 to examine COVID-19 hospitalizations and the relationship between hospital-acquired infection (HAI) rates, hospital characteristics, and testing practices across US hospitals during different periods of the pandemic. Hospitals included in the analysis were those with sufficient laboratory data on patients admitted with COVID-19 infection. Sufficient laboratory data was considered at least 1 SARS-COV-2 test result (reverse transcription-polymerase chain reaction or antigen). For each hospital-month in which sufficient laboratory data were available, data were captured on all hospital discharges and associated SARS-CoV-2 test results for that month.

The researchers used multivariable generalized estimating equation negative-binomial regression models to assess associations between monthly rates of HAI per 1000 patient-days and the variant-specific period of the pandemic, admission testing rates, and hospital characteristics. COVID-19 hospitalizations were categorized as community onset if the first positive SARS-CoV-2 test result was collected up to 7 days prior to admission to 3 days after admission. Hospitalizations for COVID-19 infection categorized as HAI or indeterminate onset were those in which the first positive test was collected after day 7 of admission or between days 4 and 7 of admission, respectively.

The final analysis included data on 5687 hospital-months captured from 288 unique hospitals, of which 156 (54.2%) had data available for the entire 24-month study period. The participating hospitals were predominantly located in the South (55.3%), most were nonteaching hospitals (74.0%), and most were in urban areas (65.9%). The pre-Delta period comprised the highest portion of hospital-months (45.5%), followed by the Delta (29.4%) and Omicron (22.1%) periods. In total, data were collected from 4,421,267 COVID-19 hospitalizations.

Overall, SARS-CoV-2 testing occurred on admission for 37.2% of all hospitalizations. In addition, SARS-CoV-2 tests were performed on admission in more than 50% of hospitalizations for 31.9% of the hospital-months assessed.

Of 171,564 hospitalizations with positive SARS-CoV-2 test results, 91.8% were categorized as community onset, 3.8% as indeterminate onset, and 4.4% as HAI.

The mean monthly rate of COVID-19 infection per 1000 patient-days was 4.15 (95% CI, 4.02-4.28) for community-onset infections, 0.27 (95% CI, 0.26-0.29) for HAIs, and 0.30 (95% CI, 0.28-0.32) for indeterminate-onset infections. Of note, peaks in HAIs were correlated with peaks in community- and indeterminate onset-infections.

In the multivariable analysis, the rate of hospitalizations for community-onset infection was significantly associated with the rate of HAI, including after adjustments for predominant variant period, admission testing rates, hospital bed size, and geographic location. The researchers noted that HAI rates increased by 178% for each 10% increase in the rate of community-onset infections (rate ratio [RR], 2.78; 95% CI, 2.52-3.07).

The adjusted rate of HAIs in the pre-Delta (RR, 1.45; 95% CI, 1.28-1.65) and Omicron (RR, 1.41; 95% CI, 1.28-1.55) periods was higher than that of the Delta period. However, adjusted HAI rates did not significantly between the Omicron and pre-Delta periods. Hospital characteristics such as population demographics, geographic location, and teaching status were not significantly associated with HAI rates.

Limitations of the study include potential misclassifications of COVID-19 infection, the inability to accurately determine infection onset, and the inability to combine a measure of community-onset infection incidence that was independent of testing practices for individual hospitals. Other limitations include variations in SARS-CoV-2 testing practices and infection control measures among the hospitals evaluated.

According to the researchers “Continued work is needed to determine optimal tools for the prevention of transmission of SARS-CoV-2 infection in a hospital setting…”

Disclosure: One study author declared affiliations with industry. Please see the original reference for a full list of disclosures.

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The study, which also aimed to determine factors that predicted treatment commencement and completion and clinical improvement, included 1367 individuals who participated in a psychological PMP at a national digital mental health service during a 5-year period.

Participants showed improvement in all outcomes evaluated, including pain interference (which improved by 19%), depression (by 26%), anxiety (by 24%), pain intensity (by 13%), pain self-efficacy (by −24%), and pain catastrophizing (by 26%).

Although a small proportion of users (13%) enrolled in the PMP but did not start treatment, those who started treatment tended to complete it and be satisfied with it. More specifically, 63% completed the entire program and 73% completed most of it while 45% were very satisfied with the program and 37% were satisfied with it.

In addition, the authors wrote, “There were a number of demographic and clinical factors associated with commencement, completion and improvement, but no decisive or dominant predictors were observed.”

“These findings highlight the effectiveness and acceptability of internet-delivered psychological PMPs in routine care and point to the need to consider how best to integrate these interventions into the pathways of care for people with chronic pain,” they concluded.

The study was limited by the lack of a control group who received a comparison treatment and the inclusion of additional forms of care in the treatment regimens of participants. In addition, the program was delivered by trained therapists, which is known to improve outcomes, so the generalizability of findings regarding the program to other programs is unclear.

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While MBIs are popular, their clinical usefulness in the treatment of pain continues to be debated. Researchers sought to synthesize and evaluate results from existing meta-analyses examining the impact of MBIs on pain. Their goal was to assess whether the effectiveness of MBIs varied according to the type of mindfulness intervention used, the type of pain experienced (chronic pain, acute pain, pain in the context of different physical conditions), and the type of control condition used as the comparator (active control vs passive control).

Five electronic databases were searched: MEDLINE, EMBASE, PsycINFO, CENTRAL, and CINAHL. Eligible meta-analyses were those published between 1979 and February 2021 that investigated the efficacy of MBIs in an adult population and measured pain or other relevant outcomes. A total of 21 meta-analyses comprising 127 studies were included in the review; all but 1 study had concluded that MBIs were either efficacious or promising in the management of pain. The quality of the meta-analyses included in the synthesis was moderate.

Long-term outcomes showed that MBIs improved pain intensity, depression, and anxiety; however, there were limited data with which to evaluate the utility of MBIs for pain interference or disability.

The most robust evidence supporting MBIs for pain management came from studies comparing MBIs with passive controls. Two trials comparing MBIs with cognitive behavioral therapy (CBT) in patients with rheumatoid arthritis or chronic low back pain demonstrated equal effectiveness of these approaches in improving pain intensity and disability/interference. Longer-term outcomes of MBIs among people with cancer showed a small but reliable improvement in depression and pain.

Overall, while results of this synthesis of meta-analyses are consistent with individual trials, showing that MBIs may be as effective as other psychosocial treatments, evidence is lacking to recommend MBIs as a first-line treatment in pain management.

A limitation of this synthesis is the small number of trials (median, 13) included in each of the 21 meta-analyses. Additionally, because there was overlap between studies in each meta-analysis, results from each meta-analysis are not independent.

The authors noted, “There are a number of conditions for which we cannot conclude that MBIs are efficacious, including acute pain, and this meta-analysis clearly indicates that the conditions under which MBIs are efficacious are, as yet, unclear.” They added, “Mindfulness-based interventions likely have a role in pain management but should not be considered a panacea.”

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Marilou Kiely, Ph.D., from the University of Montreal, and colleagues obtained data from phase 3 randomized controlled trials to explore sex differences in adverse events following seasonal influenza vaccines. Risk ratios (RRs) comparing solicited reactions in women versus men were pooled; the risk for bias and I² statistic for heterogeneity was assessed. The main analysis was stratified into younger and older cohorts (18 to 64 years and 65 years and older).

Data were included for 34,343 adults from 18 studies (12 with individual-level data and six with aggregate data). The researchers found that the risk for injection site reactions was higher in women versus men for both younger and older participants, with RRs of 1.29 and 1.43, respectively. For systemic reactions, the risk in women was also higher, with RRs of 1.25 and 1.27 for younger and older participants, respectively. The risk for severe reactions was also elevated in women, with higher RRs in younger versus older participants for systemic reactions (RRs, 2.12 and 1.48, respectively). No variation was seen in RRs between quadrivalent and trivalent vaccines.

“We found a higher risk of solicited reactions following influenza vaccines in females compared with males,” the authors write. “Transparent disclosure of this risk could increase the trust in public health authorities and limit vaccine hesitancy.”

One author disclosed ties to the pharmaceutical industry.

Abstract/Full Text

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In order to provide insight into the effectiveness of the seasonal influenza vaccine in preventing severe acute respiratory infection (SARI)-associated hospitalization during the 2023-2024 Northern Hemisphere influenza season, study authors evaluated data from the Network for the Evaluation of Vaccine Effectiveness in Latin America and the Caribbean–influenza [REVELAC–i] between March 27, 2023 and July 9, 2023. “The 2023-24 Northern Hemisphere influenza vaccine formulation contains antigenically similar A/Victoria/4897/2022 (H1N1)pdm09–like virus (egg-based vaccines) and A/Wisconsin/67/2022 (H1N1)pdm09–like virus (cell-based vaccines) and might offer similar protection against influenza A(H1N1)pdm09 if these viruses predominate during the 2023-24 Northern Hemisphere influenza season,” the authors explained.

The analysis included 2780 cases of SARI-associated hospitalization, of which 900 (32.4%) patients tested positive for influenza. Among those who tested positive, 15.3% had received a 2023 seasonal influenza vaccine. Of the 1880 patients who tested negative, 28% had received the vaccine. Using mixed effects logistic models adjusting for age, week of onset of symptoms, and presence of at least 1 preexisting condition, and accounting for country as a random effect, vaccine effectiveness was reported to be 51.9% (95% CI, 39.2-62.0) overall and 55.2% (95% CI, 41.8-65.5) against the predominant influenza A(H1N1)pdm09 virus. Among young children and older adults, overall vaccine effectiveness was 70.2% and 37.6%, respectively. 

“Although the timing and intensity of influenza epidemics in one hemisphere are not necessarily predictive of subsequent epidemics in the opposite hemisphere, this report might help health officials in Northern Hemisphere jurisdictions prepare for a potentially early influenza season and highlight the benefits of vaccination,” the authors noted. 

The CDC’s Advisory Committee on Immunization Practices recently issued updated guidelines for the prevention and control of seasonal influenza with vaccines for the 2023-2024 season. Routine annual influenza vaccination is recommended for all patients 6 months of age and older who have no contraindications. 

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Although SSRIs are known to be effective in treating postnatal depression, the long-term consequences of SSRI use on maternal and child outcomes have been underexplored. To close this knowledge gap, researchers used longitudinal data from the Norwegian Mother, Father, and Child Cohort Study to determine if postnatal SSRI treatment had a moderating effect on maternal and child outcomes related to postnatal depression over 5 years.

A diagnosis of postnatal depression was measured at 6 months postpartum for each maternal participant using the 6-item version Edinburgh Postnatal Depression Scale and the Hopkins Symptom Checklist (SCL-8). Maternal depression was evaluated by the SCL-8 at 1.5, 3, and 5 years postpartum.  Partner relationship satisfaction was also assessed using the 5-item short version of the Relationship Satisfaction Scale at 6 months, 1.5 years, and 3 years postpartum. For child outcomes, internalizing and externalizing behaviors were assessed using select items from the Child Behavior Checklist (CBCL) at 1.5, 3, and 5 years. Children’s motor and language development were also measured using the Ages and Stages Questionnaire at 1.5 and 3 years. Finally, offspring ADHD at 5 years was recorded.

Of the 61,081 mother-child pairs, 14.2% (n=8671) of mothers met the criteria for postnatal depression diagnosis and 2.0% (n=177) of those participants self-reported postnatal SSRI use. Among the women with postnatal depression, 45% (n=80) received SSRIs during pregnancy.

Multiple regression analysis showed that postnatal depression was significantly associated with increased maternal depression, reduced relationship satisfaction, higher levels of child internalizing and externalizing behaviors, poorer motor and language development, and ADHD symptoms at each factor’s measurement time point (all, P <.001).

When considering the impact of postnatal treatment on these measures, moderation analyses revealed that SSRI use improved maternal depression at postpartum year 1.5 (moderation β, -0.08; 95% CI, -0.12 to -0.04; P <.001) and year 5 (moderation β, -0.08; 95% CI, -0.14 to -0.02; P =.01). Treatment also attenuated the negative impact of postnatal depression on maternal relationship satisfaction at postpartum month 6 (moderation β, 0.17; 95% CI, 0.13-0.21; P <.001), year 1.5 (moderation β, 0.14; 95% CI, 0.09-0.19; P <.001), and year 3 (moderation β, 0.14; 95% CI, 0.08-0.20). Furthermore, SSRI use moderated the adverse effect on child ADHD at age 5 years (moderation β, −0.17; 95% CI, −0.24 to −0.10; P <.001) and the levels of child externalizing behaviors at ages 1.5 (moderation β, −0.08; 95% CI, −0.14 to −0.3; P =.006) and 5 years (moderation β, −0.13; 95% CI, −0.21 to −0.06; P =.002).

Study authors concluded, “These findings support the notion that adequate treatment of postnatal depression may predict normalization in child behavioral problems associated with the condition.”

This study’s limitation is the use of maternal self-reported data, potentially resulting in inaccurate information regarding medication use and children’s emotional and behavioral problems.

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Previous studies have indicated the need for prevention and management of hematoma expansion. However, those reports often have not distinguished between absolute and relative expansion, have defined hematoma expansion in dichotomous terms, and have not examined whether baseline hematoma volume influences outcomes of hematoma expansion.

For the current study, researchers retrospectively analyzed 2163 patient cases from 8 participating sites in Italy, Germany, Canada, China, and the US. Patients were age 18 and older; had been diagnosed with primary, non-traumatic ICH via computed tomography at baseline; and had follow-up imaging up to 3 days after either symptom onset or time last seen well.

At 3-month follow-up, patients still living completed the modified Rankin Scale (mRS) to measure functional recovery. The data collectors were blind to study goals. Absolute (change in volume) and relative hematoma expansion (percent change in size) in these patients was defined across 4 categories, from none through severe (12.5 mL absolute expansion, or 66% relative expansion).

Three months after initial presentation, nearly 57% of patients had scores between 4 and 6 on the mRS, indicating poor outcomes. Severe absolute (18.3% vs 7.2%; P <.001) and relative (13.9% vs 6.5 %; P <.001) expansion were more common in patients who had poor outcomes than in those with more favorable outcomes; and conversely, greater expansion independently predicted poor outcome. For example, in patients with baseline hematoma volume <15 mL, severe relative (odds ratio [OR], 1.71; 95% CI, 1.07-2.74; P =.025) or absolute (OR, 4.10; 95% CI, 1.80-9.36; P =.001). This relationship held for medium-sized baseline hematomas as well, but not for hematomas larger than 30 mL at initial presentation. Mild or moderate hematoma expansion was not associated with worse outcomes.

“This observation shows the value of focusing on patients with small to moderate ICH size in future studies attempting to show clinical benefit and return to functional independence through reduction of HE [hematoma expansion], despite their overall lower risk of HE compared to larger bleedings,” the researchers wrote.

They also noted, “Further research is also needed to accurately predict severe HE, as most of the currently available prediction tools are based on a dichotomic definition of HE (commonly defined as > 6 mL and or > 33% growth) that does not take into account different degrees of HE severity.”

Limitations of the study included the fact that the results did not account for blood pressure changes during treatment, which could affect hematoma expansion. Also, some severely affected patients may have been excluded by study protocols; and the 90-day follow-up period might have been too brief to capture the full trajectory of patient recovery in hematoma expansion.

Disclosures: Several authors reported research support and consulting fees from pharmaceutical companies and other nongovernmental organizations.

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Study participants were patients from the University of Miami, Miami, Florida, scheduled to undergo elective, outpatient orthopedic surgery. Participants were randomly assigned to receive either standard care or the AR intervention prior to undergoing surgery. The control group that received standard care was given the standard surgical instruction packet alone, while the AR group received the standard surgical instructions in addition to the AR intervention. The AR experience provided these participants with a visual walkthrough of their trip to the operating room, as narration was provided by their surgeon via the AR headset. The entire intervention lasted approximately 3 minutes. Anxiety levels were measured 4 times throughout the study using the State-Trait Anxiety Inventory (STAI). These surveys were administrated at screening (baseline), postintervention, prior to the operation, and following the operation. The primary endpoint of the study was the difference in STAI scores from the screening survey to the preoperative survey.  

A total of 95 patients were included in the analyses, with 46 randomly assigned to the AR intervention and 49 randomly assigned to the control group. The average baseline STAI score did not significantly differ between the AR (35; SD, 9.8) and control (35; SD, 12) participants, and there were no significant differences in the demographic or clinical factors between the groups.

There was a significant mean difference in STAI score between the AR and control groups at both the postintervention (P =.01) and preoperative (P =.01) assessments. From baseline to postintervention assessment, participants who received AR exhibited a decrease of 3.1 STAI points (SD, 5.7; 95% CI, −5.0 to −1.1) while control participants showed no change (0.1; SD, 3.7; 95% CI, −1.2 to 1.3). At the preoperative evaluation, the AR group again showed a decrease of 2.4 points (SD, 7.3; 95% CI, −4.6 to −0.3) from baseline. However, the control group’s mean difference increased by 2.6 points (SD, 8.4; 95% CI, 0.2 to 4.9) at this time point. No significant differences were found in STAI scores from screening to postoperative surveys in either group and no differences were found between groups with respect to postoperative pain or narcotic pill use.

These data suggest that the administration of AR surgical instructions could help to reduce preoperative anxiety in patients. Study authors noted, “The ultimate goal of our AR experience was to educate and prepare the patient for what to expect, potentially mitigating the cognitive and physiological burden of anxiety they perceived surrounding their surgery.”

Limitations of the study include the single-center trial design and the inclusion of solely English-speaking participants. Replication of this study across multiple sites and expansion of voiceover languages are needed to confirm the generalizability of these results.

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Using relevant data from EMBASE, MEDLINE, PsycINFO, ALL EBM, and CINAHL, researchers conducted a systematic review and meta-analysis to determine the effect of metformin in patients with PCOS with insulin sensitivity and a higher body mass index (BMI).

The researchers used a random effects model to perform meta-analyses and stratified patients into subgroups by BMI (<25 kg/m² and ≥25 kg/m²). They also performed the quality appraisal in terms of risk for bias.

Primary outcomes included BMI, homeostatic model assessment of insulin resistance, hirsutism, number of patients with regular menstrual cycles, and duration of menstrual cycles. Noncritical outcomes included weight, fasting glucose, and fasting insulin.

The researchers reviewed a total of 1660 studies, selecting 32 randomized controlled trials and 28 systematic reviews. The included studies varied from low (n=8), to moderate (n=16), to high (n=8) risk for bias.

The researchers used 23 RCTs to study metformin use vs placebo. Compared with patients in the placebo groups, those in the metformin treatment group showed reduced:

• BMIs (mean difference [MD], -0.53; 95% CI, -0.95 to -0.12 kg/m²);
• Insulin resistances (MD, -0.50; 95% CI, -0.91 to -0.09); and
• Menstrual cycle durations (MD, -38.25; 95% CI, -52.77 to -23.74 days).

There were no significant findings in hirsutism or the number of patients with regular menstrual cycles.

Compared with women in the placebo group, those with PCOS and normal weight (BMI <25 kg/m²) showed larger reductions in:

• Waist-hip ratio (MD, -0.01; 95% CI, -0.02 to -0.01);
• Free androgen index (MD, -1.01; 95% CI, -1.72 to -0.29); and
• Androstenedione (MD, -5.40; 95% CI, -8.65 to -2.15 nmol/l).

Women with PCOS and higher BMI (≥25 kg/m²) showed reductions in:

• BMI (MD, -0.89, 95% CI -1.43 to -0.35 kg/m²);
• Fasting glucose (MD, -0.13, 95% CI -0.23 to -0.02 mmol/l);
• Total cholesterol (MD, -0.41, 95% CI -0.68 to -0.14 mmol/l); and
• LDL (MD, -0.35, 95% CI -0.62 to -0.08).

The researchers also compared metformin plus lifestyle interventions with placebo plus lifestyle interventions in 8 RCTs. Compared with patients using placebo with lifestyle changes, those using metformin with lifestyle changes reported a lower BMI (MD, -1.09; 95% CI, -2.12 to -0.06 kg/m²). However, compared with placebo, patients using metformin had more menstrual cycles and mild gastrointestinal side effects (OR, 3.28; 95% CI, 1.64-6.57).

Limitations of this study included a lack of trials on patients with a BMI less than 25 kg/m² and adolescents with PCOS, the exclusion of non-English studies, and low certainty of evidence for some outcomes

According to the researchers, “Metformin should be considered as an efficacious adjunct to lifestyle interventions in adults with PCOS, especially for those with a higher BMI, to improve weight loss, insulin resistance and lipids.”

Disclosures: 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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Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer. The affected product was found to be contaminated with Bacillus cereus, a gram positive anaerobic bacterium. In immunocompromised individuals, use of the contaminated product may result in serious infections, such as endocarditis and necrotizing soft tissue infections. 

At this time, there have been no reports of adverse events related to this recall. Adverse events and quality issues should be reported to the FDA’s MedWatch program.

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Taehyun Roh, Ph.D., from Texas A&M University in College Station, and colleagues used data from the Youth Risk Behavior Surveillance System (2015 to 2019) to examine the factors associated with e-cigarette use and the relationship between e-cigarette use and asthma among U.S. adolescents.

The researchers found that male gender, previous combustible product use, substance use, and depression were associated with higher odds of ever using e-cigarettes. Current use was associated with age and White race. Among adolescents who have never used combustible products, e-cigarette use was significantly associated with asthma in both Texas and the entire United States, after adjusting for other factors (odds ratios, 1.32 and 1.18, respectively).

“Raising awareness, implementing stricter regulations, and promoting alternative coping mechanisms for mental health are potential interventions to mitigate respiratory health problems in youth. By increasing knowledge about the harmful effects of e-cigarette use, individuals will be able to make informed decisions and potentially discourage adolescents from initiating or continuing e-cigarette use,” the authors write. “Future longitudinal studies are warranted to confirm the observed associations and establish causality.”

Abstract/Full Text 

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At this point, Maricopa County public health officials have confirmed 289 heat-associated deaths, the Associated Press reported. As of Sept. 16, another 262 deaths are under investigation for being heat-associated.

Amid a historic heat wave from Texas across New Mexico and Arizona to the California desert, Phoenix had its three hottest months since record-keeping started in 1895. July had a 31-day streak of days that were at or above 110 degrees Fahrenheit. In 1974, the previous record of 18 straight days was set. For June, July, and August, the daily average temperature in this huge metro area was 97 degrees F, up from 96.7 degrees F three years ago, the AP reported.

It can take weeks and months to confirm whether deaths were heat-related. By this same time last year, there were 80 fewer confirmed heat-associated deaths and 46 fewer under investigation. In late 2022, the county had confirmed 378 heat-associated deaths, but that swelled to 425 after investigations concluded.

Roughly 75 percent of Maricopa County’s confirmed heat deaths were at bus stops, in yards, driveways, parking lots, and parks. Another 74 deaths happened indoors, including 63 in homes where air conditioning was not working or on, the AP reported. About 44 percent of the deaths were among people who were homeless.

Phoenix is hot even now, but temperatures have been gradually dropping, mostly below 100 degrees F, with some variation, the AP reported.

Associated Press Article

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Commercially available blue light glasses prevent ultraviolet radiation and specific short-wavelength visible light from directly reaching the eye. For the study, researchers aimed to assess whether visual performance and sleep quality in adults is improved with blue light glasses compared with nonblue light glasses.

The researchers utilized multiple electronic databases for randomized controlled trials (RCTs) in adults that assessed blue light glasses relative to nonblue light glasses. Primary outcomes consisted of the change in visual fatigue and critical flicker-fusion frequency (CFF) between baseline and follow-up. Key secondary endpoints included best-corrected visual acuity (BCVA), patient satisfaction with visual performance, proportion of participants with reduced daytime alertness, serum melatonin levels, and subjective sleep quality.  

A total of 17 RCTs in 6 countries involving 619 participants were included in the review, with 65% of studies assessed as having a high risk for bias due to unblinded outcome assessors. No meta-analyses were performed for any of the outcome measures due to the lack of quantitative data and general heterogeneity across studies.  

Subjective visual fatigue scores were relatively the same with blue light glasses vs nonblue light glasses. Similarly, little to no difference in CFF was observed with blue light glasses compared with not wearing these glasses. Significant differences were also not observed in BCVA between blue light vs nonblue light filtering lenses. Results for sleep measures were uncertain, with included trials reporting mixed results from heterogenous study populations.    

“Overall, the results of this review indicate that future high-quality research is required to more clearly define the potential effects of blue-light filtering lenses on visual performance, sleep and macular health, including whether efficacy and safety outcomes are distinctly different study populations,” the researchers concluded.

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

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Researchers conducted a modeling study with deidentified person-level COVID-19 data from the California Department of Public Health from July 2022 to January 2023. The researchers aimed to determine whether increasing the uptake of bivalent COVID-19 boosters and nirmatrelvir-ritonavir reduces diagnoses and severe COVID-19 outcomes in high-risk populations. Collected data included positive SARS-CoV-2 molecular test results, reports of COVID-19-related hospitalization and mortality, and COVID-19 vaccination status (full, partial, or boosted).  

Study patients were stratified by age group, including those aged 0 to 17, 18 to 49, 50 to 64, 65 to 74, 75 to 84, and those aged 85 years and older. Of note, patients who were partially vaccinated were classified as fully vaccinated as they represented less than 4% of total COVID-19 outcomes.

The primary outcomes included COVID-19 diagnosis, COVID-19-related hospitalization, and COVID-19-related mortality. The researchers used quasi-Poisson regression models to predict the number of weekly COVID-19 outcomes by age group and vaccine status over a 6-month period. Data captured from these models were then used to estimate total the number of averted outcomes, including number needed to treat (NNT), associated with each intervention (ie, bivalent booster or nirmatrelvir-ritonavir receipt).

A total of 1,128,004 confirmed COVID-19 diagnoses were included in the final analysis, of which 43,684 (3.9%) and 5876 (0.5%) were COVID-19-related hospitalizations and mortality events, respectively. Patients aged 65 and older accounted for more than 60% of hospitalizations and 83% of mortality events. At baseline, 82% of patients were partially vaccinated, 73% were fully vaccinated, and 60% had received a booster. The rate of bivalent booster administration was highest among patients 65 years and older, representing 36% of all booster doses received.

Within a period of 6 months, the regression model predicted the occurrence of 1,174,195 (95% CI, 985,150-1,403,574) COVID-19 diagnoses, 48,893 (95% CI, 42,503-56,281) hospitalizations, and 7189 (95% CI, 6239-8311) mortality events.

Further analysis showed that bivalent booster coverage among 70% of the overall population was predicted to avert 187,201 (95% uncertainty interval [UI], 168,691-205,233; NNT, 111) COVID-19 diagnoses, 9066 (95% UI, 6736-10,511; NNT, 2273) hospitalizations, and 1811 (95% UI, 1394-2375; NNT, 11,378) mortality events.

Receipt of an additional bivalent booster dose in patients aged 65 years and older was predicted to avert 10,794 (95% UI, 9439-12,333; NNT, 177) COVID-19 diagnoses, 2725 (95% UI, 1923-3275; NNT, 698) hospitalizations, and 690 (95% UI, 527-855; NNT, 2757) mortality events. For unvaccinated patients, receipt of a bivalent booster dose was predicted to avert 95,458 (95% UI, 87,586-101,917; NNT, 50) COVID-19 diagnoses.

Nirmatrelvir-ritonavir uptake of 70% in eligible populations was predicted to avert 4809 (95% UI, 3365-5813; NNT, 18) hospitalizations and 1292 (95% UI, 798-1594; NNT, 67) mortality events. The predicted number of averted hospitalizations (4458; 95% UI, 3121-5388; NNT, 14) and mortality events (1252; 95% UI, 778-1537; NNT, 50) was similar in patients aged 65 years and older. 

Limitations of this study include the reliance on historical data, the possibility of underpredicted COVID-19 outcomes, and the lack of data on the effect of prior COVID-19 infection and immunocompromised status.

In regard to bivalent boosters and nirmatrelvir-ritonavir, “This study provides evidence on the public health benefit of utilizing both interventions in the United States and highlights potential opportunities for policymakers to improve the promotion and accessibility of these live-saving interventions,” the researchers concluded.

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Half of individuals screened for lung cancer currently smoke. Investigators therefore sought to generate data to select components for an evidence-based adaptive intervention for smoking cessation treatment in the lung cancer screening setting via the PLUTO trial (ClinicalTrials.gov Identifier: NCT02597491). The trial, which evaluated 636 individuals enrolled in lung cancer screening who opted to take part in a TLC program, assessed 2 TLC program modifications: (1) providing individuals who showed no early response to the TLC program with the option of participating in medication therapy management (MTM) along with TLC, and (2) providing individuals who did show an early response to the TLC program to participate in less-frequent counseling/follow-up sessions.

Study participants were enrolled starting in October 2016 and completed an 18-month survey by April 2021. From June 2021 to December 2022, the researchers analyzed participant data and surveys using a 2-stage, sequential, multiple assignment, randomized trial (SMART) design. Eligible participants had low-dose computerized tomography (LDCT) for lung cancer screening (LCS) scheduled or ordered or were LCS-eligible, were currently smoking daily, were aged 55 to 80 years, and were willing to choose a date for quitting within the following 12 weeks.

The study employed 3 different interventions:

• Standard TLC: intensive telephone coaching (at least monthly) combined with recommended nicotine replacement therapy (recommended but not required) for 1 year.
• TLC+MTM: the standard TCL program with added MTM, which involved an initial hour-long consultation with a pharmacist to identify a prescription medication (covered by insurance) to add to the TLC program (such as bupropion, varenicline, nicotine spray, nicotine inhaler, or combination medications. Pharmacists also had 3 to 6 short follow-up phone calls with patients during the year-long program.
• Quarterly TLC: quarterly telephone coaching combined with recommended nicotine replacement therapy for 1 year.

In stage 1 of the study, participants were initially randomly assigned to either 4 weeks or 8 weeks of standard TLC. At the end of that period, participants in the 4- and 8-week cohorts were reassigned to intervention groups for the study’s second stage, based upon their “early response” to TLC treatment. Participants that did not respond to early treatment were randomly assigned to either standard TLC or TLC+MTM; those that did respond to early treatment were randomly assigned to either standard TLC or quarterly TLC.

The primary outcome was 6-month prolonged smoking abstinence at 18 months, which was self-reported. Nonabstinence was defined as smoking at least once during 7 consecutive days or at least once during 2 consecutive weekends during the 6-month period.

Of the 636 study participants, 510 (80.2%) did not respond to early treatment after stage 1, and 126 (19.8%) did respond. The participants’ median age was 64.3 (interquartile range [IQR], 59.6-68.8) years, 35.9% were female, the median cigarettes smoked per day was 20.0 (IQR, 10-20), and the median pack-years was 47.1 (IQR, 36.3-59.8).

The survey response rate at 18 months was 83.2%. At 6 months postintervention, the overall 6-month prolonged smoking abstinence rate among the standard TLC intervention groups was 24.4% (129 of 529 participants), and the overall 7-day point prevalence smoking abstinence rate was 36.1% (191 of 529 participants).

For the primary analysis using multiple imputation in those not responding to early treatment at 6 months postintervention, 37 of 208 participants (17.8%) in the TLC+MTM cohort self-reported 6-month prolonged abstinence vs 34 of 208 participants (16.4%) in standard TLC cohort (adjusted odds ratio [aOR], 1.13; 95% CI, 0.67-1.89; P =.66).

A total of 24 of 55 (43.6%) participants responding to early treatment at 6 months postintervention in the quarterly TLC cohort reported 6-month prolonged abstinence vs 34 of 58 (58.6%) for TLC (aOR, 0.54; 95% CI, 0.25-1.17). In the quarterly TLC cohort, 32 of 55 participants (58.2%) had a 7-day point prevalent abstinence vs 40 of 58 participants (69.0%) for TLC (aOR, 0.64; 95% CI, 0.29-1.40).

Most participants received combination nicotine replacement therapy (range, 82.3%-89.1% among the TLC groups), with no significant differences observed. In addition, 116 of 254 participants (45.7%) assigned to TLC+MTM accepted referral to MTM, and 98 individuals (38.6%) completed at least 1 visit.

Among several limitations, the sample size was relatively small for some secondary outcomes, and smoking abstinence data were self-reported. Also, participants were from the Midwestern US and predominantly White.

“[O]ffering a referral program to MTM along with TLC for patients continuing to smoke did not offer additional benefit,” the study authors concluded. The results further suggested that “TLC was more effective with at least monthly contact than quarterly contact, but the difference was not statistically significant.” Nevertheless, noted the study authors, “Clinically meaningful long-term quit rates were observed across TLC,” which “supports the feasibility and use of integrating longitudinal tobacco cessation care into the LCS setting.

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Dimitra V. Pouliopoulou, from Western University in London, Ontario, Canada, and colleagues conducted a systematic literature review to assess whether respiratory training and exercise-based rehabilitation interventions are associated with improved functional exercise capacity and improved quality of life in adults with PCC. The analysis included 14 randomized controlled studies (1,244 patients)

The researchers found that rehabilitation interventions were associated with improvements in functional exercise capacity with moderate-certainty evidence among seven of the trials (standardized mean difference, −0.56). Compared with the current standard of care, these improvements had a 99 percent posterior probability of superiority, although there was significant uncertainty and imprecision regarding the probability of experiencing exercise-induced adverse events (odds ratio, 1.68; 95 percent credible interval, 0.32 to 9.94).

“The findings of this systematic review and meta-analysis suggest that rehabilitation interventions are associated with improvements in functional exercise capacity, dyspnea, and quality of life, with a high probability of improvement compared with the current standard care,” the authors write.

One author disclosed ties the pharmaceutical and health care technology industries.

Abstract/Full Text

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The 3-month, open-label extension trial enrolled 484 patients from multiple study sites in China, India, and Russia. Almost all (99.4%) of those who completed the 3-month, double-blind part of the PERSIST trial entered the trial. Those who received galcanezumab during PERSIST continued to receive it in a dose of 120 mg monthly at all 3 monthly visits of the open-label extension. Those who received placebo during PERSIST received an initial, 240 mg loading dose of galcanezumab, then 2 monthly 120 mg doses of the drug. The open-label extension study’s primary outcome measure was the mean change from double-blind baseline in the number of monthly migraine headache days (MHDs) by month 6. Secondary outcome measures were reduction in monthly MHDs from double-blind baseline to month 6, functional outcomes, safety, and tolerability.

The full 6 months of the study were completed by 96% of patients. Patients who continued to receive galcanezumab, 120 mg monthly, had a continued reduction from baseline in the mean number of monthly MHDs, which slightly increased from 4 days at the end of the double blind period to 4.6 days at the end of the extension, and 66% of patients who had a response to galcanezumab of at least 50% at month 3 maintained this response to month 6. Patients in the group that received placebo during PERSIST had a rapid reduction in the number of monthly MHDs after they began to receive galcanezumab. In this group, the mean reduction in MHDs from baseline to month 6 was 4.6 days.

“The long-term benefits of galcanezumab were also supported by improvements in other efficacy and functional endpoints,” the study report authors wrote. “All safety findings were consistent with the known long-term safety profile of galcanezumab; no patients experienced a treatment-related serious adverse event.”

These findings prompted the study report authors to conclude that “Galcanezumab was efficacious and well-tolerated in patients with episodic migraine from China, India and Russia, for up to 6 months.”

Limitations of this study were the absence of a comparator arm or blinding, which limits the interpretability of the results obtained during the open-label period, and the brevity of the study, which leaves the longer-term safety and efficacy of galcanezumab undetermined in these patients.

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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The effects of PTSD on patients with epilepsy are not well understood. Previous studies have shown that PTSD can impair executive functions and memory. Researchers conducted a study to assess the cognitive effects in patients with drug-resistant epilepsy (DRE) who display signs of PTSD.

The study group consisted of 54 patients aged 18 to 54 with DRE, including 27 men and 27 women participants. The control group had 61 participants without long-term illness or psychiatric symptoms, including 43 women and 18 men participants.

All participants answered a questionnaire and performed the Attention Network Test (ANT) tasks to determine executive attentional control. Emotional inhibition was tested using the Go/No-Go task. 

The researchers used the Post-traumatic Stress Disorder Diagnosis Scale for DSM-5 (PDS-5) to assess PTSD symptoms. After completing the questionnaire, participants were interviewed by a psychologist according to the DSM-5 international guidelines.

Compared with the control group, there were lower attentional executive control scores among participants with epilepsy (t-test, -3.05; degrees of freedom [df], 109; P =.003). When evaluating groups with and without PTSD, however, compared with participants without PTSD, those with PTSD had improved executive attentional control (t-test, -2.26; df, 48; P =.028).

Compared with the control group, participants with PTSD also reported better executive attentional control, but the results were insignificant. 

When analyzing all participants with epilepsy, the researchers reported a negative correlation between PDS-5 score and attentional executive control (Pearson’s r, 0.361; P =.039). There was a positive relationship between PDS-5 and ANT task performances.

Errors in behavioral inhibition correlated with the severity of PTSD scores (Pearson’s r, 0.602; P =.023). Emotional bias measured using response times showed a negative correlation with hypervigilance (Pearson’s r, 0.571; P =.033).

Participants with more PTSD symptoms showed a faster response reaction time in an aversive condition in the Go/No-Go task. 

There were no major differences reported between patients with and without PTSD for anxiety or depression (P <.05).

There was a positive correlation reported for seizure anticipation among participants with more PTSD symptoms and those who were more alert. Compared with participants without PTSD, those with PTSD symptoms showed improved seizure control.

The researchers wrote, “Patients with epilepsy presenting PTSD symptoms seem to be characterized by attentional overcontrol and difficulties with emotional inhibition (towards anger-related stimuli).”

“These cognitive responses may be associated with hyperactive traumatic memory, which may promote difficulty in managing the threat of re-exposure to traumatic stimuli during inter- and peri-ictal period (epilepsy-specific PTSD symptoms),” they noted. “This cognitive profile could be explained by the maintenance of PTSD symptoms associated with fear and anxiety of seizure occurrence.”

Study limitations included the lack of formal validation of the questionnaires created and the differences and age and gender ratios between study groups. 

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Patients who receive treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, such as semaglutide, may experience delayed gastric emptying due to the drug’s mechanism of action (MOA).¹ Symptoms may include nausea, vomiting, heartburn, pain, or bloating.² However, the symptoms of delayed gastric emptying resulting from GLP-1 receptor agonists may be similar to symptoms of gastroparesis.³

Recent reports have revealed that patients who receive semaglutide-containing medications, such as Ozempic^® and Wegovy^®, have developed gastroparesis.^4,5 Given the resemblance in symptoms between delayed gastric emptying and gastroparesis, it is essential for clinicians to gain awareness of the best approach for managing gastroparesis in patients receiving GLP-1 receptor agonists. How should clinicians perform a differential diagnosis? What are counseling points patients should receive regarding GLP-1 receptor agonists’ MOA?

To shed light on the aforementioned questions and more, we spoke with 2 clinicians: Nancy Bono, DO, chair of family medicine at New York Institute of Technology College of Osteopathic Medicine (NYITCOM), and Eleanor Yusupov, DO, assistant professor of clinical specialties at NYITCOM.

What are probing questions clinicians should ask patients who come in with generic gastric symptoms in order to perform a differential diagnosis for gastroparesis?

Dr Bono: Start with a review of system (ROS), an inventory of body systems obtained by asking a series of questions to identify signs and/or symptoms the patient may be experiencing or has experienced. This includes constitutional symptoms — for example, fever and weight loss — as well as gastrointestinal (GI) symptoms like abdominal pain, constipation, diarrhea, heartburn, loss of appetite, nausea, and vomiting. 

Dr Yusupov: Patients should be asked in-depth questions regarding their GI symptoms, including nausea, vomiting, abdominal pain, abdominal distention, painful or difficult swallowing, bloating, early satiety, diarrhea, or constipation. In addition, the presence of fever, weight loss, location, and description of the abdominal pain, as well as any association of symptoms with meals should be ascertained. Patients should be asked about their medications, history of diabetes, motility disorders, and surgeries.

What are some key differential diagnoses clinicians should keep in mind when patients present with prolonged broad generic gastric symptoms, such as nausea, vomiting, and diarrhea, if they are a patient with type 2 diabetes or obesity who initiated a GLP-1 receptor agonist? What is the benchmark for these symptoms being expected adverse events of new therapy vs a concern?

Dr Bono: You need to review the patient’s diet. One recommendation would be smaller meals, which can help alleviate nausea by reducing the amount of food that needs to be digested at once. Smaller, more frequent meals can help to stabilize blood sugar levels, which, in turn, can help to prevent nausea caused by dips in blood sugar. Another recommendation would be to avoid high-fat foods, fried foods, and fatty foods, including fast food, as well as foods high in sugar, which tend to be the toughest for the body to digest and the most likely to cause nausea while taking a GLP-1 medication. 

Hydration is also key to preventing or minimizing nausea. Zofran can be prescribed to lessen nausea for a few days. The main concern is to stop treatment when you suspect pancreatitis, the pain felt in the upper left side or middle of the abdomen. The pain may be worse within minutes after eating or drinking at first, more commonly if foods have a high fat content. It may also become constant and more severe, lasting for several days. Amylase and lipase tests are used to detect pancreatitis. If the enzymes circulating in your bloodstream are elevated, then the medication needs to be stopped. 

Dr Yusupov: Clinicians should keep in mind viral illness, acute pancreatitis, gallbladder disease, and kidney injury. Nausea, vomiting, diarrhea, or constipation are common with initiation or dose increase of GLP-1 agonists. However, we get concerned any time the symptoms are severe, do not improve quickly, or are associated with abdominal pain.

If a patient is experiencing medication-induced gastroparesis due to semaglutide, what patient-specific and disease-specific factors should physicians consider when determining the next steps to manage the gastroparesis?

Dr Bono: Reglan (metoclopramide). This medication increases the movements in your digestive system, helping the food to pass through more quickly and efficiently to treat gastroparesis.

Dr Yusupov: Delayed gastric emptying is expected while taking semaglutide; it is related to the MOA of this drug. However, individual patient tolerability of the associated symptoms is critical. Most patients experience mild GI symptoms and learn to manage them. Therefore, they are able to continue treatment. If symptoms persist despite dietary and lifestyle modifications or become severe, semaglutide needs to be stopped.

What treatment options should be considered for patients who develop gastroparesis when on a GLP-1 receptor agonist? Does management for gastroparesis in this patient population differ from current guidelines?

Dr Bono: Reglan (metoclopramide). No.

Dr Yusupov: Patients should be counseled to eat smaller meals, avoid foods with high fat content, as well as avoid eating close to their bedtime. GLP-1 agonist dose should not be increased unless patients can tolerate the medication without significant GI side effects. The approach to gastroparesis management in this patient population is similar to current guidelines. [The] GLP-1 agonist should be stopped due to its effect on motility. The use of prokinetic medications (metoclopramide) is off-label in patients without diabetes. Ondansetron can be tried (off-label) to manage nausea and vomiting due to gastroparesis.

For physicians with patients newly on GLP-1 receptor agonists, specifically semaglutide for weight management, what are critical counseling points for the patient?

Dr Bono: Semaglutide is a peptide that works by mimicking a hormone called glucagon-like peptide 1 (GLP-1), which targets an area of the brain that regulates appetite and food intake. Semaglutide must be taken consistently to see long-term weight loss effects. As soon as someone stops taking the drug, their body fat and former appetite tend to return. The analogy can be similar to someone having high blood pressure — you’re taking the medication for life.

Dr Yusupov: Patients should be counseled that GLP-1 agonists slow stomach emptying and decrease appetite. They should also be informed how to make specific nutrition changes, as well as what to expect when initiating the treatment or increasing the dose. It is critical to advise patients to drink plenty of water (I recommend 64 oz of water a day). In addition to GI effects of this medication class and ways to prevent or minimize these effects, patients should be informed of the potential risk of thyroid C-cell tumors and advised to report voice changes, painful or difficult swallowing, or neck lumps.

How can physicians communicate to patients the severity of gastric symptoms and when to seek help during the counseling process?

Dr Bono: [Explain] that most drugs have their risks and side effects, and semaglutide is no different. Consideration can be to stay on the same dose for a few weeks instead of going up in dose, which can lessen the effects of the GI symptoms. 

Dr Yusupov: It is important to counsel patients to call their physician if they develop vomiting or abdominal pain, fatigue, persistent diarrhea, or constipation. We definitely want to hear back from our patients if they are experiencing significant abdominal pain.

The post Clinician Insights on How to Manage Semaglutide-Induced Gastroparesis: Part II appeared first on The Cardiology Advisor.

To investigate the overall risk for death in patients with MDD and suicidal behavior, researchers conducted a population-based cohort study analyzing data from the Stockholm MDD Cohort.

The researchers collected data from patients aged 18 and older who were diagnosed with episodes of MDD between January 1 2012 to December 31, 2017 in the region of Stockholm. Patients were divided into 2 groups — either the major depressive disorder-suicidal behavior (MDD-SB) group or the MDD-non-SB group — based on at least 1 record of suicidal behavior during their MDD episode(s). Suicidal behavior was defined according to International Classification of Diseases, Tenth Revision (ICD-10)codes for intentional self-harm (X60-X84).

The 2 groups were matched based on age, sex, year of MDD diagnosis, and sociodemographic status. The primary endpoint was all-cause mortality. Secondary endpoints included comorbid conditions, medications, HCRU, and work loss.

Of the 145,577 patients included in the study, a total of 158,169 unipolar MDD episodes were identified. The MDD-SB group of patients (n=2219) had a mean age of 40.9 (SD 18.6), with 1415 episodes (63.2%) reported by women and 825 episodes (36.8%) reported by men. The MDD-non-SB control group had 11,109 recorded MDD episodes across 9574 patients. Their average age was 40.8 (SD 18.5), with 7046 episodes (63.4%) reported by women and 4063 episodes (36.6%) reported by men.

The all-cause mortality rate was 2.5 per 100 person-years in the MDD-SB group and 1.0 per 100 person-years in the MDD-non-SB group, with a hazard ratio (HR) of 2.62 (95% CI, 2.15-3.20).

There was also a higher proportion of add-on treatments for those in the MDD-SB group (medication, 17.8%; electroconvulsive therapy [ECT], 3.3%) compared with the MDD-non-SB group (medication, 4.9%; ECT, 0.4%). This trend persisted at both index and 12 months after.

The 2 factors most strongly associated with a risk for suicidal behavior were a previous history of suicidal behavior and age, with patients age 20 and younger or 70 and older having the highest risks.

Furthermore, there were notable differences in average work loss days (87.1 vs 53.0), outpatient physician visits (11.4 vs 7.7), and inpatient bed days (11.1 vs 2.1) between the MDD-SB group and MDD-non-SB group, respectively.

The researchers concluded, “These findings show an association between suicidal behavior and all-cause mortality in patients with MDD and warrant additional interventional studies in health care practice.”

The results of this study may have been limited by the criteria used to attribute individual episodes of suicidal behavior, potentially resulting in an overestimation of episode prevalence.

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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Semaglutide-containing medications sold under the brand names Ozempic^® and Wegovy^® have made headlines after being linked to gastroparesis. Both medications belong to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1 is a regulator of appetite and caloric intake and is known to have various drug interactions due to delayed gastric emptying as a result of therapy.

In a 2-year study (ClinicalTrials.gov Identifier: NCT03693430) of semaglutide use in patients with overweight or obesity, researchers found that 82.2% of patients taking semaglutide experienced mild to moderate gastrointestinal (GI) adverse events compared with 53.9% in the placebo group. There were no reports of gastroparesis in the study.¹ 

While semaglutide and other GLP-1 agonists cause adverse events, such as nausea, vomiting, diarrhea, and a range of other GI symptoms, these effects of delayed gastric emptying are reported to be reduced after 20 weeks of use. ²  

What Are Other Causes of Gastroparesis? 

Diabetes is the most common underlying cause of gastroparesis and can damage the vagus nerve, leading to impaired muscular function in the stomach and small intestine.³ Studies show that the 10-year cumulative incidence of diabetic gastroparesis is estimated to be 5.2% among patients with type 1 diabetes and 1% in patients with type 2 diabetes.⁴ 

Other known causes of gastroparesis include celiac disease, neurological disorders such as Parkinson disease and central nervous system tumors, collagen vascular disorders such as scleroderma and systemic lupus erythematosus, hypothyroidism, and medications.⁵

Medications that can result in delayed gastric emptying leading to gastroparesis include proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, opioid analgesics, progesterone, lithium, cyclosporin, and levodopa.⁵

Research on semaglutide-induced gastroparesis is limited, but patient reports have been increasing.

Case Studies of GLP-1-Induced Gastroparesis

1. A 52-year-old woman with a 10-year history of diabetes presented with a 7-month history of postprandial epigastric pain with concomitant fullness, bloating, and nausea that was unrelieved after proton pump inhibitors and antispasmodics. She was initiated on weekly semaglutide subcutaneous injection 1 month prior to symptom onset, and her diabetes is currently well-managed (A1c, 5.7%). A 4-hour scintigraphic gastric emptying (SGE) test indicated delayed gastric emptying. Semaglutide was held for 6 weeks, leading to symptom resolution.⁶

2. A 57-year-old woman with a 16-year history of diabetes presented with a year history of abdominal bloating, nausea, and vomiting. The patient was initiated on dulaglutide subcutaneous weekly injection 15 months prior and has an A1c of 8.2%. A SGE confirmed delayed gastric emptying. Dulaglutide was held for 4 weeks, resulting in a gradual resolution of symptoms.⁶

3. A 52-year-old man with a history of diabetes, hypertension, and hyperlipidemia presented with a 1-week history of nausea, abdominal distension, and pain. The patient was receiving daily liraglutide for glycemic control (A1c, 7%). After temporary discontinuation of liraglutide, dietary modification, and a short course of antiemetics and metoclopramide, the man’s symptoms resolved.⁷

Semaglutide and Gastroparesis in the News

In July 2023, 3 women told CNN that they developed severe GI symptoms after receiving treatment with semaglutide injections. Two of the women were diagnosed with severe gastroparesis.⁸

Then, in early August 2023, a woman sued Novo Nordisk and Eli Lilly, the manufacturers of semaglutide and tirzepatide injections, alleging that the companies failed to warn patients of severe GI symptoms. The woman reported stomach pain, severe vomiting, GI burning, hospitalization due to stomach issues, and a loss of teeth due to excessive vomiting.⁹ 

While both medication package inserts state that delayed gastric emptying is possible with the medication and may affect drug absorption, they do not specifically state that gastroparesis is a potential risk.¹⁰ The GI adverse events listed on the semaglutide package inserts appear to be mild to moderate, including nausea, stomach pain, bloating, constipation, diarrhea, and vomiting.^10-12 

As the popularity of these medications increases, experts expect an increase in GI adverse event reports in the future. The US Food and Drug Administration (FDA) told CNN in a statement that they have “received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report.”⁸ 

However, the FDA also told CNN that they are unable to confirm if the medications directly caused gastroparesis or an alternative etiology.⁸

Clinician Guidelines for Managing Gastroparesis

Clinicians do not recommend semaglutide for patients who experience symptoms of gastroparesis.⁴ An SGE over a duration of 3 hours is recommended when evaluating for gastroparesis in patients with upper GI symptoms. If an SGE assessment is not feasible, wireless motility capsule or a stable isotope breath test is a reasonable alternative.¹⁶

Dietary modifications with small-particle, low-fat, nondigestible food are recommended to provide symptom relief and enhance gastric emptying. Metoclopramide, domperidone, or 5-HT4 agonists are recommended to improve gastric emptying. Antiemetics are suggested for symptom control but do not improve gastric emptying. Central neuromodulators, ghrelin agonists, and haloperidol are not recommended in therapy.¹⁹

There is limited research on the management of medication- or drug-induced gastroparesis. Based on current case studies, management includes discontinuation of the medication, symptom control with antiemetics and prokinetic agents per guidelines, nutritional support, and dietary modification.⁷ Further research is warranted to identify next steps for patients who develop gastroparesis after semaglutide use, and whether reinitiation of therapy is possible after discussion of benefit vs risk with their health care provider.

The post What We Know About Semaglutide Adverse Events and Gastroparesis: Part I appeared first on The Cardiology Advisor.

Past research has demonstrated the association of statins with increased bone mineral density (BMD) and lower fracture risks. Investigators assessed the relationship between different types and dosages of statins and the risk for osteoporotic fracture among older adults.

A retrospective population-based study was conducted using data from the Korean National Health Insurance Service-Senior cohort. Patients aged at least 60 years without a previous history of osteoporosis who were started on statin therapy and had no previous statin prescriptions within the past 12 months (statin users) were included in the analysis. The study period began on January 1, 2004, and participants were observed until December 31, 2012.

A total of 21,318 statin-users and 344,338 nonusers were included in the study. Mean participant ages were 70.5 years among the statin-user group and 70.3 years among the nonuser group.

Among the statin-user group, 7.9% (1675 participants) of participants developed major osteoporotic fractures with an overall incidence of 21.6 per 1000 person-years (PY). A total of 15.5% (53,284 participants) of participants in the nonuser group developed major osteoporotic fractures with an overall incidence of 24.1 per 1000 PY.

Vertebral (69.4%), distal radius (28.9%), hip (16.1%), and humerus (1.40%) fractures were the most common osteoporotic fractures among both groups.

Compared with the nonuser group, statin use was associated with a lower risk of developing major osteoporotic fractures (hazard ratio [HR], 0.77; 95% CI, 0.72-0.83),  vertebral fractures (HR, 0.70; 95% CI, 0.64-0.77), and hip fractures (HR, 0.49; 95% CI, 0.38-0.62).

Osteoporotic fracture risk decreased with increasing age at initiation of statin therapy (HRs among patients aged 60-69 years vs ≥80 years, 0.79 vs 0.65, respectively). Statin users had a lower risk for nonvertebral fractures regardless of age, while incremental risk reduction in vertebral fractures generally declined with increasing age at statin initiation.

The risk for major osteoporotic fracture was reduced by 14% among participants exposed to statins for less than 2 years (HR, 0.86; 95% CI, 0.81-0.91) and by 21% among those exposed for 2 years or more (HR, 0.79; 95% CI, 0.72-0.87). Additionally, the risk for major osteoporotic fracture decreased with increasing statin dosage.

Study limitations included the retrospective, observational design, lack of data on BMD, potential confounding factors, and detection bias. Additionally, treatment interruption and adherence were not evaluated.

The study authors concluded, “Based on these findings, we can speculate that the beneficial effect of statin may be more pronounced in aged and fragile bones. Given the increasing prevalence of vertebral fractures with subsequent mortality, statin treatment should be recommended even in very old people.”

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The U.S. Department of Health and Human Services (HHS) announced Wednesday that it will spend $600 million to buy and offer the tests, produced by 12 domestic manufacturers, and it will begin accepting orders for those tests on Monday through covidtests.gov. Households that order will receive four free tests.

“The Biden-Harris Administration, in partnership with domestic manufacturers, has made great strides in addressing vulnerabilities in the U.S. supply chain by reducing our reliance on overseas manufacturing,” HHS Secretary Xavier Becerra said in an agency news release. “These critical investments will strengthen our nation’s production levels of domestic at-home COVID-19 rapid tests and help mitigate the spread of the virus.”

This plan will not only get tests in the hands of people in case of another COVID-19 surge, but it will also increase domestic manufacturing capacity, officials noted. Manufacturers can sell tests directly to retailers, rather than the government, if there is significant demand for them, said Dawn O’Connell, assistant secretary for preparedness and response at the HHS.

The government’s investment will pay for about 200 million tests to replenish the country’s stockpile, the HHS said. Free tests have been previously offered at other times during the pandemic, including from early 2022 through summer of that year and from late 2022 until the spring of 2023.

More Information

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