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

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

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

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

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

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Sadiya S. Khan, M.D., from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues examined the correlation between body mass index and adverse pregnancy outcomes (APOs), including hypertensive disorders of pregnancy, preterm birth, small-for-gestational-age birth, and gestational diabetes, and postpartum cardiovascular disease (CVD) risk factors in a sample of adults from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be Heart Health Study, enrolled in their first trimester. A total of 4,216 participants were enrolled and had a follow-up visit at 3.7 years postpartum.

The researchers found that hypertensive disorders of pregnancy, preterm birth, small-for-gestational-age birth, and gestational diabetes occurred in 15, 8, 11, and 4 percent of participants, respectively. Compared with normal body mass index, early pregnancy obesity was associated with an increased incidence of postpartum hypertension, hyperlipidemia, and diabetes, even after adjustment for baseline CVD risk factor levels. Higher incidence rates of postpartum hypertension and hyperlipidemia were seen in association with APOs. A small proportion of the association between obesity and incident hypertension was mediated by hypertensive disorders of pregnancy (13 percent), which did not mediate associations with incident hyperlipidemia or diabetes.

“This contributes to the growing evidence base that APOs largely represent a marker of preexisting CVD risk that is unmasked during pregnancy and suggests growing emphasis on early pregnancy or prepregnancy interventions before an APO occurs,” the authors write.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Edward Jude, M.D., from the Tameside and Glossop Integrated Care National Health Service Foundation Trust in Ashton-under-Lyne, England, and colleagues screened 1,388 individuals attending an emergency department and not known to have diabetes, using hemoglobin A1c (HbA1c). The Finnish Diabetes Risk Score (FINDRISC), which identifies individuals at high risk for developing T2D, was calculated for all patients.

The researchers found that 61.1 percent of the patients had normal glucose tolerance, while 30.2 and 8.6 percent had prediabetes and diabetes, respectively, with similar proportions seen in men and women. Each unit increase in the FINDRISC was associated with a significant increase in the risk for prediabetes and diabetes (odds ratios, 1.09 and 1.16, respectively); after adjustment for age and sex, the associations were attenuated but remained significant (odds ratios, 1.07 and 1.15, respectively). A higher incidence of glucose intolerance was seen for South Asian and other ethnic minorities compared with Caucasians (42.65 versus 37.8 percent), and they were twice as likely to have prediabetes or diabetes (odds ratios, 1.90 and 2.61, respectively).

“Opportunistic HbA1c-based screening in accident & emergency departments, particularly those in high-risk and hard to reach groups, could make an important contribution to identifying undiagnosed individuals who will benefit from early treatment and lifestyle changes and so reduce their risks of long-term complications,” Jude said in a statement.

One author disclosed ties to the pharmaceutical industry.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The post Switching to Faricimab Improves Aflibercept-Resistant Diabetic Macular Edema appeared first on The Cardiology Advisor.

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

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

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

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

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

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

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

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

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

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

The post Diabetes, Higher BMI Identified as Risk Factors for RCC Upstaging appeared first on The Cardiology Advisor.

Tara T. M. Lee, M.B., B.S., from the Norfolk and Norwich University Hospitals NHS Foundation Trust in the United Kingdom, and colleagues conducted a multicenter trial involving 124 pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5 percent who were randomly assigned to receive standard insulin therapy or hybrid closed-loop therapy; both groups used continuous glucose monitoring. The percentage of time in the pregnancy-specific target glucose range (63 to 140 mg/dL), as measured from 16 weeks of gestation to delivery, was the primary outcome.

The researchers found that the mean percentage of time that the maternal glucose level was in the target range was 68.2 ± 10.5 and 55.6 ± 12.5 percent in the closed-loop and standard-care groups, respectively. Results for the secondary outcomes were consistent; compared with those in the standard-care group, participants in the closed-loop group spent less time in a hyperglycemic state, had more overnight time in the target range, and had lower glycated hemoglobin levels. There were no unanticipated safety problems associated with closed-loop therapy during pregnancy.

“These results support the recommendations, proposed in the guideline from the National Institute for Health Care Excellence, that hybrid closed-loop therapy should be offered to all pregnant persons with type 1 diabetes,” the authors write.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The post Group and Individual Prenatal Care Elicit Similar Gestational Diabetes Risk appeared first on The Cardiology Advisor.

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

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

The researchers assigned patients into 4 categories based on BMI:

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

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

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

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

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

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

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

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

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

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

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

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

Noting that women are diagnosed with diabetes mellitus at a later age than men, David Holland, from The Benchmarking Partnership in Alsager, England, and colleagues analyzed the HbA1c levels of 146,907 individuals who underwent single testing only and had HbA1c ≤50 mmol/mol in one laboratory between 2012 and 2019 (cohort 1). The findings were replicated among 938,678 individuals tested in six laboratories between 2019 and 2021 (cohort 2).

The researchers found that women younger than 50 years old had markedly lower HbA1c distribution than men in cohort 1, by a mean of 1.6 mmol/mol, while the difference in distribution of HbA1c was less pronounced for individuals aged 50 years and older (mean difference, 0.9 mmol/mol). HbA1c in women lagged by up to 10 years versus men among those aged younger than 50 years. In cohort 2, the findings were similar. An estimated additional 17 percent of undiagnosed women aged younger than 50 years in England and Wales could be reclassified as having diabetes mellitus, which could contribute to up to 64 percent of the mortality rate difference for men/women aged 16 to 50 years with diabetes mellitus.

“We suggest that the threshold for diagnosis of diabetes mellitus may be too high by approximately 2 mmol/mol in women under the age of 50,” the authors write.

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

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

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

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

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

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

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

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

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

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Kimberly Danae Cauley Narain, M.D., Ph.D., M.P.H., from the University of California in Los Angeles, and colleagues examined the association of the UCMyRx intervention with HbA1c and systolic blood pressure (SBP) among 931 patients with T2D, self-reporting Hispanic ethnicity. Participants had one or more visits with a UCMyRx pharmacist (treatment) or two or more visits, two or more years apart, during the study window (March 2, 2013, to Dec. 31, 2018; comparison). The exposure included review of laboratory results, medication reconciliation, and development of personally tailored interventions to address barriers to adherence and increase guideline-concordant care.

The researchers found that having one or more UCMyRx visits was associated with a reduction in HbA1c concentration in adjusted analyses (β = −0.46 percent), but no change was seen in SBP.

“Given the potential of pharmacist-led interventions like UCMyRx to help improve outcomes in T2D while simultaneously supporting primary care physicians, it is important to facilitate their broader uptake,” the authors write.

Abstract/Full Text

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The triglyceride-glucose index is a biomarker that can indicate insulin resistance and metabolic complications. Insulin resistance is associated with inflammation, but its connection to arthritis remains unclear. 

Researchers at Soochow University in Suzhou, Jiangsu, China conducted an observational study to assess the relationship between arthritis and an individual’s triglyceride-glucose index. The researchers collected data from the National Health and Nutrition Examination Survey (NHANES), an extensive cross-sectional survey of the health and nutritional status of the United States general population conducted between 2007 and 2018.

The researchers excluded data from individuals younger than age 20, pregnant women, and individuals with missing data on arthritis, triglyceride levels, or glucose levels. Individuals self-reported arthritis data through a questionnaire. 

The researchers recruited a total of 14,817 participants with an arthritis incidence of 28.29%, of whom 65.33% were younger than age 60 and 51.18% were women. Compared with men, more women had arthritis.

Of non-Hispanic White participants, a majority had arthritis (51.40%) compared with those without arthritis (37.58%). Individuals with arthritis were more likely to have a higher education level, obesity, and hypertension. Compared with participants without arthritis, those with arthritis also had a higher triglyceride-glucose index. 

The adjusted model of the multivariable logistic analysis revealed a positive correlation between arthritis risk and triglyceride-glucose index (odds ratio [OR], 1.15; 95% CI, 1.07-1.23; P =.0002). 

Subgroup analysis of the relationship between triglyceride-glucose and arthritis showed that sex, hypertension, and vigorous and moderate activity levels remained relatively consistent between groups.

However, the researchers observed an additive effect of other risk factors with the triglyceride-glucose index. Specifically, participants with normal body mass index (BMI; OR, 1.43; 95% CI, 1.24-1.69), younger than age 60 (OR, 1.29; 95% CI, 1.17-1.41), and without diabetes (OR, 1.20; 95% CI, 1.11-1.31) showed a more pronounced positive association between triglyceride-glucose index and arthritis. 

The researchers reported a saturation effect value relationship between triglyceride-glucose index and arthritis, calculating a more significant positive correlation below a triglyceride-glucose index of 8.08 μmol/L (OR, 2.01; 95% CI, 1.46-2.75; P <.0001). 

Study limitations included a lack of longitudinal follow-up data, medication data, and information regarding other inflammatory markers. 

According to the researchers, “The observed association suggests potential underlying mechanisms that link insulin resistance, metabolic dysfunction, and chronic inflammation to the pathogenesis of arthritis.”

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Several trials have assessed the effects of lifestyle changes and various combinations of glucose-lowering medications on diabetes remission among patients with type 2 diabetes; however, it is unknown whether combining several therapeutic approaches would increase remission rates and which combinations can be easily followed by patients to sustain remission.

Therefore, researchers performed the open-label parallel randomized controlled Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes with iGlarLixi (REMIT-iGlarLixi; ClinicalTrials.gov Identifier: NCT03130426) trial to assess whether remission can be achieved with an induction regimen comprised of a fixed-ratio combination of basal insulin glargine 100 U/mL and lixisenatide (iGlarLixi) plus metformin, combined with changes in diet and exercise.

Patients with type 2 diabetes lasting 5 years or less aged between 30 and 80 years were recruited from 8 sites in Canada. The primary outcome was the first onset of diabetes relapse within 12 weeks following randomization or later.

Participants were randomly assigned 1:1 to either a 12-week intensive metabolic intervention with a combination of basal insulin glargine 100 U/mL, lixisenatide, metformin, and lifestyle approaches, followed by 52 weeks of follow-up (intervention group, n=79) or standard diabetes care for 12 weeks followed by 52 weeks of follow-up (control group, n=81). Mean patient age was 55.5 years, 43.8% were women, and 86.9% were White.

The intervention group had a significantly lower rate of diabetes relapse compared with the control group (adjusted hazard ratio, 0.57; 95% CI, 0.40-0.81; P =.002). The intervention group had a median remission time of 93 days (95% CI, 85-161 days), while the control group had a median remission time of 48 days (95% CI, 29-78 days).

At 24 weeks, 38.0% of participants in the intervention group remained in complete or partial remission compared with 19.8% in the control group. At 36 weeks, 31.6% of the intervention group and 17.3% of the control group remained in complete or partial remission.

At 48 weeks, 27.8% of participants in the intervention group remained in remission, compared with 14.8% in the control group. At 64 weeks, the percentages were 22.8% vs 11.1%, respectively. There were no statistically significant differences between the groups at later time points.

Study limitations included the lack of blinding among participants and research staff and the short follow-up period.

The study authors concluded, “This trial suggests that the studied multimodal therapeutic approach can successfully induce drug-free remission of type 2 diabetes for at least 6 months in patients diagnosed within the previous 5 years and taking up to two glucose-lowering agents. ”

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

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Yang Xu, PhD, of Peking University First Hospital in Beijing, China, and colleagues conducted a longitudinal study of 93,598 adults with type 1 or 2 diabetes undergoing routine care in Stockholm, Sweden. Each patient received a hemoglobin A1c (HbA1c) variability score based on the percentage of their outpatient HbA1c measurements within a 3-year period that differed by 0.5% or more (5.5 mmoL/mol or more) from the HbA1c value at their visit immediately prior. HbA1c variability score was categorized as 0-20% (reference), 21%-40%, 41%-60%, 61%-80%, and 81%-100%.

Risks for poor kidney outcomes significantly increased with higher HbA1c variability score category, Dr Xu and colleagues reported in the American Journal of Kidney Diseases. The risks for chronic kidney disease (CKD) progression increased from 25%, 31%, 45%, to 60% asHbA1c variability score categories increased from 21% to 100%, respectively, compared with the reference. The risk for acute kidney injury (AKI) increased 12%, 17%, 22%, and 23%, respectively. The risk for worsening albuminuria increased 17%, 21%, 26%, and 28%, respectively.

“This finding supports a role for long-term glycemic variability in the development of kidney complications and illustrates the potential usefulness of this metric for risk stratification at the bedside beyond a single HbA1c test,” Dr Xu’s team wrote.

They acknowledged that HbA1c is less useful in CKD. The study lacked information on patients’ diet, body mass index, medication changes, and diabetes duration, all of which affect HbA1c.

According to editorialists Mengyao Tang, MD, MPH, and Sahir Kalim, MD, MMSc, of Massachusetts General Hospital and Harvard Medical School in Boston, Massachusetts, “the study by Xu et al emphasizes the importance of considering additional glycemic metrics beyond single HbA1c readings in diabetes and CKD care, and highlights how much more work needs to be done in this field.”

Dr Tang and Dr Kalim pointed out that HbA1c variability score cannot differentiate a downward (ie, improving) from upward (ie, worsening) HbA1c trajectory, which is a limitation in clinical practice. Other measures of glycemic variability also have their shortcomings.

“Given these limitations, [continuous glucose monitoring] is an appealing option for providing a more comprehensive glycemic profile, including quantifying short-term [glycemic variability] in CKD patients.”

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State-based adult obesity prevalence was calculated by race, ethnicity, and location based on self-reported height and weight data from the Behavioral Risk Factor Surveillance System.

The 22 states with an adult obesity prevalence ≥35 percent include Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin. In 2021, only 19 states had an adult obesity prevalence ≥35 percent, and 10 years ago, no state had an adult obesity prevalence ≥35 percent. The researchers observed differences in obesity prevalence by race and ethnicity, with American Indian or Alaska Native adults having a prevalence of 33 percent, Black adults 38 percent, Hispanic adults 32 percent, and White adults 14 percent.

“Our updated maps send a clear message that additional support for obesity prevention and treatment is an urgent priority,” Karen Hacker, M.D., director of the CDC National Center for Chronic Disease Prevention and Health Promotion, said in a statement. “However, we know the key strategies that work include addressing the underlying social determinants of health such as access to health care, healthy and affordable food, and safe places for physical activity.”

More Information

2022 Adult Obesity Prevalence Maps

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Prior research has indicated that diabetes mellitus (DM) nearly doubles the risk of RVO, and that patients with psoriasis are more likely to develop DM.

Researchers in Korea examined records from 2009 to 2012 from the Korean National Health Insurance Service Claims Database universal healthcare system and national health screening data. Patients older than 20 years who had been diagnosed with type 2 DM based on that data were included in the study. The 2,570,846 participants had not been diagnosed with RVO before, or during the index year, through 2018. The investigators compared individuals who received treatment at an outpatient clinic following diagnosis of psoriasis (n=23,725) with the control group of remaining patients.

Patients with psoriasis were more likely to be older, men, and current smokers compared with the control individuals. They were more likely to have hypertension, dyslipidemia, and end-stage renal disease compared with the other group.

Individuals who developed RVO (n=42,885) were more likely to be women and older. They were more likely to regularly exercise and not drink or smoke. They more frequently had hypertension, dyslipidemia, and end-stage renal disease.

RVO was more common among diabetic patients with psoriasis compared with individuals without psoriasis (incidence rate 3.14 per 1000 person-years vs 2.44 per 1000 person-years).

With multivariable Cox proportional models and adjustments for covariates, the researchers found that patients with psoriasis were at higher risk of developing RVO compared with control individuals (hazard ratio 1.216 95% confidence interval 1.11-1.33). 

“The precise mechanisms underlying the association between psoriasis and RVO remain unclear. However, it is hypothesized that the inflammatory state and increased vascular complications observed in psoriasis patients may contribute to the occurrence of RVO,” the study authors explain. “These shared pathogenic mechanisms provide a plausible explanation for the association.”

Limitations of this study include a basis of definitions of psoriasis and retinal vein occlusion on claims data and lack of consideration of severity of disease or use of medications.

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Michael Fang, Ph.D., from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues characterized the age distribution of type 1 diabetes diagnosis in the United States using data from the National Health Interview Survey (NHIS). Data were included from 947 adults with type 1 diabetes in NHIS cycles from 2016 to 2022, representing about 1.3 million U.S. adults.

The researchers found that the distribution of age at diagnosis of type 1 diabetes was right-skewed, reaching a peak around 15 years of age. The median age at diagnosis was 24 years, with later diagnosis for men than women (median, 27 versus 22 years) and for racial/ethnic minorities versus non-Hispanic White adults (median, 26 to 30 years versus 21 years). Diagnosis after age 30 years occurred in 37 percent of participants, with higher rates seen for men and for racial/ethnic minorities.

“The onset of type 1 diabetes during adulthood is common, particularly in men and racial/ethnic minority patients,” the authors write. “Tools integrating clinical measures and biomarkers may improve the accuracy of diagnosis for these patients.”

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

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This retrospective cohort study was designed to examine the effect of morbid obesity in adults who received β-lactam/β-lactamase inhibitor combinations for P aeruginosa-associated HABP/VABP at 2 academic medical centers in Detroit, Michigan from August 2014 to February 2021. Researchers assigned 285 patients into 2 groups on the basis of BMI, including those with morbid obesity (n=95) and those without morbid obesity (n=190). The primary outcome was a composite of presumed treatment failure, defined as all-cause in-hospital mortality or persistent infectious symptoms attributed to P aeruginosa-associated HABP/VABP.

The researchers captured data on patients’ characteristics, demographics, and comorbidity burden at baseline. Organ function and illness severity were also assessed via electronic health record data captured within 48 hours prior to or on the same day of primary culture collection. The researchers also generated propensity scores through multivariable logistic regression to ensure unbiased comparisons between the groups.

Among patients with and without morbid obesity, the median ages were 64 and 61 years, 54.7% and 72.6% were men (P =.003), and 91.6% and 80.5% required intensive care unit admission (P =.016), respectively. Overall, the most common comorbid conditions included chronic obstructive pulmonary disease/asthma (31.6%), heart failure (20.4%), and chronic kidney disease (23.2%).

Further analysis was performed among a pseudo-population, with between-group differences in covariate biases balanced via inverse probability of treatment weighting. Results indicated an increased risk for presumed treatment failure among patients with morbid obesity (adjusted odds ratio [aOR], 1.675; 95% CI, 1.465-1.979).

In the multivariable logistic regression model, predictors of presumed treatment failure included delayed treatment initiation (aOR, 1.47; 95% CI, 1.28- 2.66) and receipt of continuous kidney replacement therapy (aOR, 1.35; 95% CI, 1.06, 1.49).

The researchers noted no difference in the occurrence of treatment-related adverse events between groups.

Limitations of the study include its retrospective design, potential confounding, and a lack of generalizability as patient enrollment occurred at 2 large health care systems in a single metropolitan area. These findings also may not be generalizable to populations in which alternative definitions of obesity are applied.

According to the researchers, “Therapeutic drug monitoring (TDM)-based dosing coupled with modified dosing administrations may be warranted for select scenarios to achieve PD [pharmacodynamic] targets, including in critically ill obese patients.”

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

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Researchers conducted the Coronary Artery Risk Development in Young Adults (CARDIA) study, which included 5115 women and men who were Black and White. The study sought to determine whether greater artificial sweetener intake and diet beverages are associated with greater volumes of visceral adipose tissue (AT), intermuscular AT, and subcutaneous AT independent of demographic and lifestyle variables, including total caloric intake and the healthy eating index. Questionnaires assessed demographic characteristics, lifestyle factors, and physical activity.

A total of 3276 participants aged 18 to 30 years at baseline attended the examination over a course of 25 years. The resulting number of participants included in the study was 3088, including 869 Black women, 867 White women, 590 Black men, and 762 White men. A dietary intake follow-up was made at year 0, 7, and 20. The researchers separated aspartame and dietary intake into 5 quintiles and saccharin intake into 3 tertiles.

The researchers noted a strong correlation between increased artificial sweetener consumption and higher volumes of visceral (P_trend =.001), subcutaneous (P_trend <.001), and intermuscular AT (P <.001).

Higher aspartame intake also correlated with greater volumes of visceral AT, subcutaneous AT, and intermuscular AT in participants who consumed aspartame in the top quintile. Higher volumes of visceral AT (8.4%), subcutaneous AT (11.6%), and intermuscular AT (10.6%) were also reported in participants who consumed aspartame in the bottom quintile. The researchers noted consuming more aspartame was linked to a higher BMI, weight, and waist circumference, with these metrics increasing during the follow-up period of 25 years.

Participants in the top tertile of saccharin intake had 10.3% higher visceral AT, 14% higher subcutaneous AT, and 10% higher intermuscular AT volumes than those in the bottom tertile. Additionally, saccharin intake was positively correlated with an increase in BMI (P <.001), weight (P_trend <.001), and waist circumference (P_trend <.001). Over the follow up period an increase in overall weight (P_trend =.03), waist circumference (P_trend =.008), but not BMI (P_trend =.06) was also positively correlated to saccharin intake.

As the intake of diet beverages increased, there was significant increase in visceral AT, subcutaneous AT (P_trend ≤.001), and intermuscular AT (P_trend <.001). Participants who consumed more diet beverages, particularly those in the highest quintile, had 10.4% higher visceral AT, 14.1% higher saccharine AT, and 14.8% higher intermuscular AT volumes than those in the lowest quintile. Diet beverage intake was associated with higher BMI, weight, and waist circumference (P_trend <.001 for all) over the period of 25 years.

Sucralose intake increased across quintiles with a corresponding increase in BMI (P_trend =.004), weight (P_trend <.001), and waist circumference (P_trend =.05). However, there were no significant associations observed between sucralose intake and AT volumes or changes in anthropometry over a period of 25 years.

The researchers reported consuming artificial sweeteners, aspartame, sucralose, and diet soda increased risk for obesity (P_trend <.001), especially with greater intake. Those in higher quintiles showed a 78% greater risk for obesity for artificial sweetener, 64% for aspartame, and 57% for diet beverages compared with those in lower quintiles.

Study limitations included self-reporting bias and the risk for adipogenesis influence from an altered microbiome.

“Coupled with evidence from microbiome and experimental studies, our findings suggest that alternatives to the national recommendations to replace added sugar with ArtSw should be considered since both may have health consequences,” the researchers concluded.

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Investigators assessed the prevalence of overweight and obesity and their effects on the risk for COVID-19-related hospitalization among patients aged younger and older than 50 years.

A systematic review and meta-analysis were conducted, including studies with patients who had reverse transcription polymerase chain reaction-confirmed COIVD-19, as well as data on body mass index (BMI), comorbidities such as overweight and obesity, and disease outcomes.

Overweight status was defined as a BMI of 25 to 29 kg/m², while obesity was defined as a BMI of at least 30 kg/m².

A total of 184 studies were included in the analysis (N=2,365,377); 59 studies included patients aged less than 50 years (440,893 hospitalizations), while 34 studies included patients aged greater than 50 years (788,669 hospitalizations). 

The prevalence of overweight and obesity was 26.33% and 36.02% among patients aged less than 50 years hospitalized with COVID-19, respectively. Among those aged greater than 50 years, the prevalence of overweight and obesity was 30.46% and 36.30%, respectively. Among all hospitalized patients with COVID-19, the pooled prevalence of obesity was 36.26%. 

Patients aged less than 50 years with overweight (odds ratio [OR], 2.186; 95% CI, 1.196-3.994; P <.011) or obesity (OR, 3.069; 95% CI, 1.679-5.610; P <.001) who were diagnosed COVID-19 had significantly increased odds for hospitalization, compared against patients with normal weight.

Among patients aged greater than 50 years, only obesity was significantly associated with increased odds for hospitalization (OR, 3.977; 95% CI, 2.757-5.735; P <.001), compared with normal weight. Overweight status was not associated with increased odds for hospitalization (OR, 0.810; 95% CI, 0.451-1.457; P <.482).

This analysis was limited by the inclusion of very few case-control studies with small numbers of participants. Additionally, high levels of heterogeneity were present among included studies in terms of patient ethnicity, nationality, and reported outcomes.

The investigators concluded, “To mitigate the risk of severe COVID-19 disease and mortality, lifestyle modification strategies should be considered, such as regular physical activity, a healthy calorie-controlled diet, and bariatric surgery if needed, particularly for those with obesity.”

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This time, it is Eli Lilly suing certain medical spas, wellness centers, and compounding pharmacies over its medication Mounjaro. The medication contains the active ingredient tirzepatide and is approved by the U.S. Food and Drug Administration to treat type 2 diabetes. The company sells Mounjaro only in prefilled single-dose pens.

The lawsuits, filed Tuesday, are meant to stop the other companies from “the unlawful marketing and sale of non-FDA approved compounded products.” In a statement issued Tuesday, the company said: “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.”

In June, Novo Nordisk sued businesses for making compounded versions of semaglutide, which is used in its type 2 diabetes drugs Ozempic and Rybelsus. The medication is also used to treat obesity under the brand name Wegovy. In its cases, Novo Nordisk has asked the companies to “cease and desist from false advertising, trademark infringement, and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.”

Eli Lilly said these compounded versions can cause “potentially serious health risks,” adding that “products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality or efficacy.”

People have reported adverse events from compounded semaglutide, according to the FDA. The agency has said patients “should not use a compounded drug if an approved drug is available.” However, Mounjaro has been on the agency’s drug shortages list since last year, along with Ozempic and Wegovy. “When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act,” the FDA said.

More Information

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Investigators sought to examine the effect of vegetarian diets on outcomes among people at high risk for CVDs.

They conducted a systematic review and meta-analysis searching MEDLINE, CINAHL, Embase, and CENTRAL databases from inception through July 2021. They included randomized clinical trials (RCTs) investigating vegetarian diets in adults with high risk for CVDs and measuring LDL-C, HbA_1c, or systolic blood pressure (SBP).

The investigators included 20 RCTs (N=1878; range of mean ages, 28-64 years) with a mean intervention duration of 25.4 weeks (range, 2-24 months). Studies were conducted primarily in the US, plus 3 in Asia, 2 in Europe, and 1 in New Zealand. Sample sizes ranged from 13 to 291 participants. Different vegetarian diets were applied across studies, some excluding all animal proteins (except non-fat dairy and egg whites), vegan diets (excluding all animal products and some studies adding vitamin B12), lacto-ovo-vegetarian diets, and lacto-vegetarian diets.

Overall, consuming a vegetarian diet for an average of 6 months was associated with decreased LDL-C (-6.6 mg/dL; 95% CI, -10.1 to -3.1), HbA_1c (-0.24%; 95% CI, -0.40 to

-0.07), and body weight (-3.4 kg; 95% CI, -4.9 to -2.0), in meta-analyses, relative to all comparison diets. The association between a vegetarian diet and SBP was not significant (-0.1 mm Hg; 95% CI, -2.8 to 2.6). The investigators noted a statistically significant among-study heterogeneity in the 19 studies included in the changes in LDL-C meta-analysis. In the 10 studies included in the changes in HbA_1c meta-analysis, heterogeneity was not statistically significant.

Among the various vegetarian diets, the greatest reduction in LDL-C was found in lacto-ovo-vegetarian diets (-14.1 mg/dL) though 80% of these RCTs restricted energy intake. Participants at high risk for CVDs had the most consistent reduction. Compared with usual diet, vegetarian diets significantly lowered LDL-C by 12.9 mg/dL. Compared with active controls, the association of vegetarian diets with LDL-C is not significant.

Participants following a vegan diet had a reduction in HbA_1c compared with the usual and the conventional energy-restricted diabetic diet. Vegetarian diets were associated with improved HbA_1c even in studies with no physical activity prescription.

The investigators noted significant very high among-study heterogeneity in the 16 studies included in changes in body-weight meta-analysis. Greatest weight reduction was noted in participants at high risk for CVD. Diets without energy restriction had greater weight reduction than diets with energy restriction (-4.7 kg vs -1.8 kg).

A moderate level of evidence for LDL-C and HbA_1c reduction was noted with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool.

Limitations of the study include using limited trials with limited participants investigating vegetarian diets in patients with CVDs, and many of the subgroup analyses were conducted with underpowered sample sizes.

“…consuming a vegetarian diet was associated with significant improvements in LDL-C, HbA_1c, and body weight beyond standard therapy in individuals at high risk of CVDs,” the investigators wrote. “Well-designed nutrition clinical trials with comprehensive dietary information are warranted to investigate the full effect of high-quality vegetarian diets in combination with optimal pharmacological therapy in people with CVDs.”

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Investigators explored the association between changes in smoking behavior and risk for CVD incidence and CVD/all-cause mortality among patients with T2DM.

An observational cohort study was conducted using data from the Korean National Health Insurance System, comprised of 349,137 patients with T2DM who smoked. A self-administered questionnaire was used to obtain information on smoking status and changes in smoking behavior.

Patients were categorized into 3 groups based on the number of cigarettes smoked per day: 1) light smokers (<10 cigarettes/day), 2) moderate smokers (10-19 cigarettes/day), and 3) heavy smokers (≥20 cigarettes/day).

Patients were then further categorized according to the difference in the number of cigarettes smoked per day from study enrollment to the end of the follow-up period: quitters (stopped smoking entirely), reducer I (≥50% reduction), reducer II (reduction from ≥20% to <50%), sustainers (reduction or increase <20%), and increasers (≥20% increase).

Newly diagnosed myocardial infarction (MI), ischemic stroke (IS), and mortality were the primary outcomes.

Mean patients age was 51.6 years and 95.2% were men. Median follow-up was 5.1 years.

Overall, 54.3% of participants were considered heavy smokers, 36.4% moderate, and 9.30% light.

The most common comorbidities overall included hypertension (45.2%), dyslipidemia (37.2%), and chronic obstructive pulmonary disease (25.1%).

During follow-up, investigators identified 6514 newly diagnosed cases of MI (1.9%), 7837 cases of IS (2.2%), and 14,932 mortalities (4.3%).

Patients categorized as quitters vs sustainers had a significantly decreased risk for MI (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.75-0.86) and IS (aHR, 0.80; 95% CI, 0.75-0.85). Among patients categorized as reducers vs sustainers, no significant association was found for risk for MI (aHR, 1.03; 95% CI, 0.94-1.13) or IS (aHR, 1.00; 95% CI, 0.92-1.08). 

Lower all-cause mortality (aHR, 0.90; 95% CI, 0.86-0.94), lower MI mortality (aHR_, 0.79; 95% CI, 0.64-0.98) and lower IS mortality (aHR, 0.67; 95% CI, 0.47-0.95) were noted among patients categorized as quitters vs sustainers.

Study limitations included reduced generalizability, the small number of female smokers, potential unreliability of self-reported smoking behavior, and unmeasured confounding.

The study authors concluded, “To reduce CVD risk and all-cause mortality, and CVD mortality, smoking cessation should be achieved rather than smoking reduction.”

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Anna Neyman, M.D., and Tamara S. Hannon, M.D., from the Indiana University School of Medicine in Indianapolis, developed practical recommendations for pediatricians regarding use of low-carbohydrate diets in patients, including those with type 1 diabetes and those with obesity, prediabetes, and type 2 diabetes.

The authors note there are safety concerns to consider for youth with diabetes who are restricting carbohydrates, including growth deceleration, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors. Low-carbohydrate diets (<26 percent energy) and very low-carbohydrate (20 to 50 g) diets are only recommended for children with type 1 diabetes under close supervision of a diabetes care team. For prevention and treatment of prediabetes and type 2 diabetes, reducing nutrient-poor carbohydrate intake by minimizing consumption of processed foods with high amounts of refined grains and added sugars is recommended. In children and adolescents, eliminating sugary beverages and juices significantly improves blood glucose and weight management. Dietary restriction of any kind has physical, metabolic, and psychological consequences, including risk for disordered eating, and poses additional risk for those with diabetes. A reduced-energy diet is most important for achieving weight loss among those for whom weight loss is medically indicated, irrespective of carbohydrate content.

“This statement is not about restrictive diets — it is about providing evidence to clinicians so they can support parents and families in making informed decisions,” Hannon said in a statement.

Abstract/Full Text

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Julianne G. Clina, from the University of Alabama at Birmingham, and colleagues compared a high-protein diet (four or more weekly servings of lean beef) and a normal-protein diet without red meat for weight loss, body composition changes, and glucose control in individuals with type 2 diabetes. The analysis included 106 adults (80 women) participating in a 52-week weight loss intervention.

The researchers found that weight loss did not differ between the groups (high protein: −10.2 kg; normal protein: −12.7 kg). Additionally, reduced fat mass and higher fat-free mass percent were seen in both groups. There were no significant differences between the groups for hemoglobin A1c, glucose, insulin, insulin resistance, blood pressure, and triglycerides improvement.

“Avoiding red meat, including beef, does not provide additional benefit for weight loss or improvements in glucose control during a weight loss intervention,” the authors write.

The study was funded by the National Cattlemen’s Beef Association.

Abstract/Full Text

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Using data from 2831 obese adults in the Chronic Renal Insufficiency Cohort Study (CRIC), investigators identified 6 weight loss phenotypes with distinct trajectories of body mass index (BMI), serum albumin, and systolic blood pressure. Class 6 had the highest 5-year all-cause mortality rate of 6.8%. It was characterized by steep and early BMI loss of more than 20%, initially stable then rising systolic blood pressure, and early decline in serum albumin followed by increasing levels. The class 6 group, accounting for 7% of the cohort, had a 1.9-fold increased risk for death compared with healthy weight individuals, Meera Nair Harhay, MD, MSCE, of Drexel University College of Medicine in Philadelphia, Pennsylvania, and colleagues reported in Kidney International Reports.

Class 3, accounting for 37% of patients, was the most common. It was characterized by a less than 5% decline in BMI, small increase in systolic blood pressure, and small increase in albumin level. The class 3 group had the lowest 5-year mortality rate at 1.5%.

The class 6 vs class 3 group were younger (60 vs 61 years), majority female (56% vs 47%), and had higher baseline BMI (37.2 vs 35.5 kg/m²), serum albumin (3.9 vs 3.8 g/dL), and systolic blood pressure (127 vs 125 mm Hg). Class 6 patients also had a lower mean estimated glomerular filtration rate (eGFR): 39.3 vs 48.9 mL/min/1.73m² and greater CKD burden, reflected by low exercise participation and intensity. The groups had similar daily caloric intake, protein intake, and lipid profiles.

Adults who rapidly lost more than 10% of BMI generally had higher death risks than those with more modest BMI loss.

In a secondary analysis examining percentage change in fat-free mass, patients with BMI loss coupled with transient or sustained loss in fat-free mass, a proxy for muscle mass, had higher death risk. Greater muscle losses are found among patients with unintentional weight loss, a domain of the physical frailty phenotype, the investigators noted.

“Our study suggests that whether weight loss is required or desired by adults with CKD and obesity, they should also be monitored with respect to concurrent changes in hemodynamics, nutrition, and body composition.”

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Researchers included data from 9 randomized controlled trials that evaluated the effects of a vegetarian diet on metabolic, anthropometric, or blood pressure outcomes vs an omnivorous diet in individuals with overweight (25-30 kg/m²) or obesity (>30 kg/m²) during a mean 7.6-month period. Among the included studies, 4 assessed lacto-ovo-vegetarian diets and 5 examined vegan diets. Primary outcomes were weight, BMI, waist and hip circumference, and body fat percentage, while secondary outcomes included fasting serum glucose, Hb1Ac, and insulin levels, and blood pressure.   

The study determined that vegetarian diets decreased weight (mean difference [MD], −3.60 kg; 95% CI, −4.75 to −2.46) and glucose (MD, −10.64 mg/dL; 95% CI, −15.77 to −5.51), compared with an omnivorous diet. However, it did not significantly decrease BMI (MD, −0.87 kg/m²; 95% CI, −1.80 to 0.06), waist circumference (MD, −3.00 cm; 95% CI, −6.20 to 0.20), hip circumference (MD, −0.86 cm; 95% CI, −3.46 to 1.74), HbA1c levels (MD, −0.40%; 95% CI, −0.89 to 0.10) or insulin levels (MD, −3.83 mU/L; 95% CI, −8.06 to 0.40) compared with an omnivorous diet. 

Vegetarian diet also did not significantly affect systolic or diastolic blood pressure compared with omnivorous diets (MD, −0.25 mm Hg; 95% CI −2.58 to 2.07 and MD, −1.57 mm Hg; 95% CI −3.93 to 0.78, respectively).

“In comparison to an omnivorous diet, [vegetarian diets] may reduce weight and glucose but the evidence is very uncertain,” according to the study authors.

Study limitations include a low quality of evidence, difference in control diets between studies, and a short follow-up duration.

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Researchers aimed to determine the likelihood of achieving weight loss by 5% or more, weight loss by 10% or more, and BMI reduction to a healthy weight in patients who were overweight or had obesity.  

The researchers extracted data from the IQVIA AEMR database on patients aged 17 years or older who had BMI data for at least 3 years ranging from January 2009 to February 2022. Exclusion criteria consisted of individuals with BMI lower than 12 or higher than 110, aged older than 70 years, and who were pregnant.

The primary outcomes were weight loss of greater than 5% and reduction of body weight to a healthy BMI (18.5-24.9). Additional outcomes included weight reduction of greater than 10% and BMI reduction to a lower category.

Data on 18,461,623 individuals were included in the final analysis (56.7% women; 43.3% men). At initial visit, 72.5% of the cohort were in the overweight or obesity category.

Five percent weight loss was achieved by 33.4% of those who were initially overweight and 41.8% of those with obesity. Additionally, reduction to a healthy BMI category  was achieved in 23.2% of persons with overweight and 2.0% of persons with obesity. Median time to achievement of 5% or greater weight loss and to the healthy weight category was 2.4 (1.4-4.0) and 2.6 (1.5-4.4) years, respectively.

The annual probability of 5% or greater reduction in weight loss was found to be 1 in 10. Notably, a higher initial BMI was associated with a higher likelihood of achieving an annual 5% weight reduction (1 in 12 in overweight vs 1 in 6 in BMI ≥45).

Conversely, the probability of achieving a healthy BMI category was more likely in those at a lower initial BMI; 1 in 19 individuals classified as overweight and 1 in 1667 with an initial BMI of 45 or higher were able to obtain a healthy BMI classification.

Supplemental analysis on annual probability of 10% or greater weight loss was found to be 1 in 24 individuals, with achievement found in 1 in 32 individuals with initial overweight, and 1 in 11 individuals with a BMI of 45 or higher. The annual probability of achieving BMI to a lower-than-initial category was found to be 1 in 13 individuals, which ranged from 1 in 19 individuals with overweight and 1 in 8 individuals with initial BMI 45 or higher.

Notably, 76.5% of those who achieved 5% or greater weight loss had stable weight loss and higher initial BMIs increased the percentage. However, a sizable amount of those who reduced BMI to a healthy weight or moved to a lower BMI category gained back the weight lost (42.8% and 43.0%, respectively).

As this was study conducted in a clinical setting, the lack of generalizability was cited as a potential limitation as it did not account for the population of US adults that are not seeking healthcare related weight loss.

 “…5% or greater weight loss was more likely than BMI reduction to the healthy weight category, especially for individuals with the highest initial BMI,” the study authors wrote. “Clinicians and public health efforts can focus on messaging and referrals to interventions that are aimed at clinically meaningful weight loss (5% or greater) for those at any level of excess weight.”.

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The Real-world Retinopathy Screening Project for Diabetic Population (RRSPD) study, guided by the National Clinical Research Center for Ophthalmic Diseases of China between December 2018 and November 2021, evaluated how lowering blood pressure levels affects DR, PDR, and DME in patients with diabetes mellitus.

A total of 152,844 participants with a diabetes duration of 4.71±5.07 years aged 64.02±10.43 years from 90 cities in 19 provincial regions of mainland China were included in the final analysis. Of these, 16,685 had DR, 2841 had PDR, and 1566 had DME. 

A total of 46.28% of patients had hypertension. Among them, only 5.32% of patients without hypertension and 0.88% with hypertension had a blood pressure lower than 120/80 mm Hg. Logistic regression analysis indicated that a history of hypertension increased the adjusted odds ratios for DR (adjusted OR=1.081; 95% CI, 1.045–1.117), PDR (adjusted OR=1.381; 95% CI, 1.280–1.491), and DME (adjusted OR=1.235; 95% CI, 1.115–1.367). 

Additionally, the prevalence of DR increased by 11.4% in normal high systolic blood pressure [SBP] ≥120 mmHg or diastolic blood pressure [DBP] ≥80 mmHg), 16.3% in hypertension-moderate (120 mmHg ≤ SBP <140 mmHg and 80 mmHg ≤ DBP <90 mmHg), and 20.3% in hypertension-high (SBP ≥140 mmHg or DBP ≥90 mmHg) blood pressure groups. An increased prevalence of PDR or DME was found in the hypertension-moderate group, but not the hypertension-intensive group. 

“This nationwide study confirmed the association between hypertension and DR, PDR, and DME in the diabetic population. We found that patients with and without hypertension benefited from a blood pressure <120/80 mmHg for reducing DR,” the researchers report. “For the sake of cardiovascular risks, the reduction is usually 10–20 mmHg, corresponding to a blood pressure target of 120–130/80–90 mmHg in diabetes. However, an appropriate blood pressure target to reduce DR in diabetes is still lacking.”

Study limitations include the possible underestimation of DR caused by using non-mydriatic one-field fundus images; unmeasured genetic, environmental, or behavioral factors; and the study’s cross-sectional nature.

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Although DM can increase the risk for many chronic diseases, its impact on breast cancer risk is not well-established. However, experts have hypothesized that due to metabolic dysfunction, DM can be related to breast cancer risk. Therefore, the authors sought to assess the association between diabetes mellitus (DM) and breast cancer risk.

Following PRISMA guidelines, they searched PubMed, Embase, and Web of Science databases for English-language cohort and case-control studies from inception until December 10, 2021 that evaluated possible associations between DM and breast cancer. Initially, 8396 studies were identified.

Excluded from the analysis were studies in which DM was diagnosed at the same time as breast cancer, or afterwards; studies of patients who developed gestational DM; cohort or case-control studies including fewer than 10 participants with breast cancer or diabetes, respectively; and studies that did not distinguish between benign and malignant tumors.

A total of 70 independent studies met the authors’ criteria for inclusion in the final meta-analysis. The study population included women aged 18 years or older who had been diagnosed with DM before their breast cancer was detected.

The primary outcome was the incidence of malignant breast cancer among patients with DM. Across all 70 studies, there was a 20% increased risk for breast cancer among patients with DM (risk ratio [RR], 1.20; 95% CI, 1.11-1.29).

There was substantial heterogeneity among studies (I², 97.9%; P-heterogeneity <.001). Regarding research findings based on study type, 24 case-control studies demonstrated a stronger association between DM and breast cancer (RR, 1.26; 95% CI, 1.13-1.40) compared with the 46 cohort studies evaluated (RR, 1.15; 95% CI, 1.05-1.27).

Studies that reported on breast cancer risk with DM based on menopausal status showed a higher risk for breast cancer among menopausal women (RR, 1.12; 95% CI, 1.07-1.17). No association was found between DM and breast cancer in premenopausal women (RR, 0.95; 95% CI, 0.85-1.05).

The authors also noted an association between DM and significantly increased risk of certain breast cancer subtypes, including the following:

• Estrogen receptor (ER) positive breast cancer (RR, 1.09; 95% CI, 1.00-1.20)
• ER negative breast cancer (RR, 1.16; 95% CI, 1.04-1.30)
• Triple-negative breast cancer (RR, 1.41; 95% CI, 1.01-1.96)

Limitations of this review include selection bias (related mainly to studies restricting inclusion to older women, thereby maximizing the number of DM and/or breast cancer cases), the inability to differentiate between type 1 and type 2 diabetes, and a lack of information regarding specific diabetes treatments, which could potentially affect the relationship between DM and breast cancer risk.

“In conclusion,” the authors wrote, “this updated systematic review and meta-analysis confirms prior findings of an increased risk of BCa [breast cancer] in women with DM. In addition, our results suggest that women with DM may have a higher risk of diagnosis with an aggressive molecular subtype of BCa compared with women without DM.” They cautioned, “Further high‐quality evidence is needed to verify the relationship between DM and BCa receptor expression, understand the underlying mechanisms of breast carcinogenesis in women with DM, and eventually provide evidence-based recommendations for BCa prevention and treatment.”

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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Teresa Janevic, Ph.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues estimated racial-ethnic disparities in T2DM following GDM in a retrospective cohort of 22,338 individuals with GDM.

The researchers found that the eight-year T2DM incidence was 11.7 percent overall and was 18.5, 16.8, 14.6, 5.5, and 5.4 percent in Black, South/Southeast Asian, Hispanic, East/Central Asian, and White individuals, respectively, with corresponding adjusted hazard ratios (95 percent confidence intervals) of 4.0 (2.4 to 3.9), 3.3 (2.7 to 4.2), 2.9 (2.4 to 3.3), and 1.0 (0.9 to 1.4) for each group compared with Whites. For Black, Hispanic, and South/Southeast Asian versus White disparities, clinical and social-structural pregnancy characteristics explained 9.3 and 23.8 percent, 31.2 and 24.7 percent, and 7.6 and 16.3 percent, respectively. Compared with Black, Hispanic, and South/Southeast Asian individuals, associations between education, Medicaid, WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) participation, and body mass index with T2DM were more pronounced among White individuals.

“While racial and ethnic inequities are substantial in type 2 diabetes after GDM, the weak associations we see of common social or structural measures and body mass index in Black, Hispanic, and South and Southeast Asian individuals demonstrate the need for greater understanding of how structural racism influences postpartum cardiometabolic risk in these groups,” Janevic said in a statement.

Abstract/Full Text

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Individuals with T2DM are at an increased risk of adverse CV events, accounting for more than 50% of mortality. Recent studies have indicated the utility of coagulation FX1 as a prognostic factor in atherosclerotic vascular disease and thrombosis. As studies on their utility in diabetic patients is lacking, researchers investigated the relationship of FX1 levels and thromboembolic events in T2DM patients.

Individuals with T2DM were enrolled in a long-term (median 72 months) observational study to assess plasma clotting factors in relation to adverse CV events. Venous blood samples were collected and analyzed for clotting proteins (plasminogen, a2-antiplasmin, tissue plasminogen activator, circulating plasminogen activator inhibitor antigen, thrombin-activatable fibrinolysis inhibitor antigen, FXI). Those with acute infection, chronic inflammatory disease, recent thromboembolic events, active malignancy, or chronic kidney disease were excluded from the study.

The primary endpoint of the study was a composite of myocardial infarction (MI), ischemic stroke, and CV death.

The analysis included 133 patients aged 66±8.0 years. Baseline median time since T2DM diagnosis was 5 (2-10) years, and mean glycated hemoglobin was 6.5% (6.1–7.1%).

In 18.8% of patients, plasma FX1 was above 120% of the upper limit, however no differences in clinical and laboratory characteristics were found when compared to those with normal FX1 levels, except for total and LDL cholesterol (R, 0.40; P <.001; and R, 0.35; P <.001; respectively).

The composite endpoint was observed in 15.8% of patients, including 1 fatal MI, 16 CV deaths, and 4 nonfatal strokes. Patients who met the composite endpoint had a higher mean FX1 level, when compared to those who did not (16.8% vs. 10.7%, P <.001).

Patients who died of CV causes had a higher mean FX1 (17.4%vs. 11.9%, P =.002), and FX1 was elevated in a higher proportion in CV death cases (46.7% vs. 15.3%, P =.003). Univariable analysis found FX1 to increase the risk of CV death (HR, 7.11; 95 CI%, 2.61–19.31; P <.001).

Subgroup analysis found that patients with concomitant coronary artery disease (CAD) who met the composite endpoint had a higher baseline FX1 (13.8% vs. 10.8% , P < .001) than those who did not meet any endpoint.

Limitations of the study include lack of recommended T2DM therapy in the cohort, which may have influenced the risk of long-term adverse CV events. As baseline, screening for CAD in asymptomatic patients was not completed and there may have been some undiagnosed cases.

“This is the first study to show that in long-term follow-up elevated FXI is a strong, independent predictor of arterial thromboembolic events, including CV death, in patients with T2DM, regardless of concomitant CAD,” the study authors wrote.

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Because oxygen consumption in the resting state is 1.5 times higher in individuals with obesity, it is especially challenging for clinicians to optimize post-extubation oxygen therapy to improve outcomes and reduce the risk for reintubation in patients with obesity. Investigators therefore aimed to compare how HFNC vs NIV affected reintubation in patients with obesity. The primary endpoint was reintubation within 96 hours following extubation.

This retrospective observational study used data from the Medical Information Mart for Intensive Care (MIMIC-IV) database, a single-center critical care database of patients hospitalized in the intensive care units (ICUs) of Beth Israel Deaconess Medical Center in Boston between 2008 and 2019.

Investigators identified 757 patients with obesity (body mass index [BMI] ≥30kg/m²) who were at least 18 years of age (median 65 years of age; 34% female; median BMI, 36.8kg/m²) and underwent either HFNC (n=282) or NIV (n=475) within 6 hours following extubation. Patients with ICU stays of less than 24 hours or those in whom treatment had been abandoned were excluded. Overall, 97 patients were reintubated (n=52 HFNC; n=45 NIV).

Investigators found no significant between-group difference in the risk for reintubation within 96 hours following extubation (odds ratio [OR], 1.50; 95% CI, 0.88-2.55; P =.127). They noted a significantly lower risk for reintubation within 96 hours after extubation among patients with severe obesity (BMI≥40kg/m²) (OR, 0.06; 95% CI, 0.0-0.39; P =.016).

No significant between-group differences were found for HFNC vs NIV in reintubation rates within 72 hours (16.9% vs 13.0%; P =.424), or within 48 hours (15.6% vs 11.0%; P =.314), respectively. Additionally, there were no significant between-group differences in in HFNC vs NIV in ICU mortality (1.3% vs 5.2%; P =.108), or in-hospital mortality (3.2% vs 5.2%; P =.571).

Investigators noted that the HFNC group vs the NIV group had significantly longer hospital stays (14 days vs 9 days; P =.005) and ICU stays (7 days vs 5 days; P =.001).

Study limitations include use of electronic health records with missing or omitted data, and the single-center retrospective design.

“This study suggests that HFNC therapy is not inferior to NIV in preventing reintubation in obese patients and appears to be advantageous in severely obese patients,” the study authors concluded.

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Researchers conducted a systematic review and meta-analysis to evaluate the efficacy and safety of revisional techniques after RYGB for weight regain or inadequate weight loss.

A literature search was performed in PubMed and Embase from inception to June 2, 2023. Prospective and retrospective studies that addressed a revisional therapeutic technique for weight regain or inadequate weight loss after RYGB and included patients aged 18 years and older, reported weight loss efficacy after intervention, and had a minimum of 20 patients at the time of revision were eligible.

A total of 39 studies were included, of which 4 studies reported on argon plasma coagulation (APC), 4 on transoral outlet reduction (TORe), 9 on TORe + APC, 4 on pouch/ gastro-jejunal anastomosis (GJA) revision, 5 on laparoscopic gastric banding (LGB), 2 on LGB + pouch resizing, 10 on distalization of RYGB (D-RYGB), and 1 on duodenal switch (DS).

For APC in 828 patients, pooled analyses revealed a body mass index (BMI) at revision of 37.0 kg/m² (95% CI, 32.5-41.4), and percentage of total weight loss (%TWL) was 6.2 (95% CI, 1.1-11.2), 11.0 (95% CI, 3.9-18.1), and 5.0 (95% CI, 4.3- 14.3) after 12, 24, and 36 months, respectively, with complications in 6.3% of cases.

Regarding TORe in 269 patients, the pooled BMI at revision was 37.9 kg/m² (95% CI, 34.7-41.1), and %TWL was 5.0 (95% CI, 2.7-7.2) after 12 months and 1.8 (95% CI, –1.8 to 5.4) after 48 months, with complications in 1.9% of cases.

For TORe + APC in 1226 patients, the pooled BMI at revision was 40.0 kg/m² (95% CI, 38.9-41.1), and %TWL decrease was 8.4 (95% CI, 6.7-10.1), 6.8 (95% CI, 3.7-9.9), 6.7 (95% CI, 3.4-10.1), and 7.3 (95% CI, –22.7 to 37.3) after 12, 24, 36, and 60 months, respectively, with complications in 4.7% of patients.

Among 116 patients with pouch/GJA revision, the pooled BMI at revision was 37.8 kg/m² (95% CI, 32.5-43.1), and %TWL was 17.2 (95% CI, 3.8-30.6), 13.6 (95% CI, 4.9-22.4), 18.0 (95% CI, 4.3-31.8), and 15.6 (95% CI, 0.4-30.7) after 12, 24, 36, and 60 months, respectively, with complications in 18.1% of patients.

For LGB in 270 patients, pooled BMI at revision was 39.7 kg/m² (95% CI, 35.1-44.2), and %TWL was 13.6 (95% CI, 4.5-22.8), 18.4 (95% CI, 14.1-22.6), 18.6 (95% CI, 7.2-29.9), 20.8 (95% CI, 6.3-35.4), and 23.1 (95% CI, 4.6-41.6) after 12, 24, 36, 48, and 60 months, respectively, with 1 death reported.

For LGB + pouch resizing in 75 patients, pooled BMI was 39.0 kg/m² at revision (95% CI, 23.8-54.1), and %TWL was 21.2 (95% CI, –1.0 to 43.4), 14.7 (95% CI, 7.2-36.4), and 17.0 (95% CI, 3.3-30.6) after 12, 24, and 36 months, respectively.

For D-RYGB in 434 patients, the pooled BMI at revision was 41.4 kg/m² (95% CI, 39.5-43.4), and %TWL was 19.7 (95% CI, 16.3-23.2), 23.6 (95% CI, 20.5-26.6), 22.9 (95% CI, 18.6-27.2), 24.2 (95% CI, 19.0-29.7), and 21.5 (95% CI, 8.5-34.5) after 12, 24, 36, 48, and 60 months, respectively. Complications occurred in 51.8% of patients.

For DS in a study of 23 patients, BMI at revision was 45.6 kg/m² (95% CI, 41.2-50.0), and %TWL was 20.4 (95% CI, 3.2-37.6) after 12 months and 34.4 (95% CI, 13.6-55.3) after 24 months, and 26.1% of patients had complications.

Among several limitations, the definitions of inadequate weight loss or weight regain were not reported or specified in most studies, the conclusions were based mostly on retrospective studies with incomplete information, and long-term follow-up data were lacking.

“Endoscopic revisional procedures show a subtle short-term effect with low complication rates,” study authors wrote. “Surgical techniques are effective on short- and mid-term but are associated with high complication rates.”

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Sophia Zoungas, Ph.D., from Monash University in Melbourne, Australia, and colleagues investigated the treatment effect of low-dose aspirin on incident diabetes and fasting plasma glucose (FPG) levels among adults aged 65 years. and older. The participants (16,209 adults) were randomly assigned (1:1) to 100 mg daily enteric-coated aspirin or placebo.

The researchers found that during a median follow-up of 4.7 years, incident diabetes cases were identified in 459 participants in the aspirin group and 536 in the placebo group. The aspirin group had a lower risk for incident diabetes (hazard ratio, 0.85; P = 0.01) and a slower rate of increase in FPG (difference in annual FPG change, −0.006 mmol/L; P = 0.004).

“Given the increasing prevalence of type 2 diabetes among older adults, the potential for anti-inflammatory agents like aspirin to prevent type 2 diabetes or improve glucose levels needs further study,” the authors write.

Abstract

More Information

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In an observational study of 5931 patients (mean age, 66 years), initiation of SGLT2i was significantly associated with a 19% lower risk for a first recurrent gout flare and a 21% lower risk for recurrent gout flares overall compared with initiation of glucagonlike peptide-1 receptor agonists (GLP-1 RA) or dipeptidyl peptidase-4 inhibitors (DPP-4i). Compared with GLP-1 RA alone, SGLT2 inhibitors were significantly associated with a 35% lower risk for recurrent flares, Guanghua Lei, MD, PhD, and Chao Zeng, MD, PhD, of Xiangya Hospital, Central South University in Changsha, Hunan, China, and colleagues reported in JAMA Network Open. Use of SGLT2i vs active comparators was associated with 8.1 and 8.8 fewer first and overall recurrent flares, respectively, per 1000 person-years.

SGLT2 inhibitor initiation also was significantly associated with a 29% lower risk for all-cause mortality compared with initiation of GLP-1 RA and DPP-4i, the investigators reported. The SGLT2i group had 6.1 fewer deaths per 1000 person-years than the active comparator group. In subgroup analysis, the lower risk for all-cause mortality among initiators of SGLT21 remained significant only compared with DPP-4i, not GLP-1 RA.

Of the cohort, 11.2% had chronic kidney disease and 7.9% had heart failure. Myocardial infarction and stroke previously occurred in 9.1% and 3.7%, respectively.

In terms of mechanisms, the investigators suggested SGLT2i might increase kidney urate elimination. It may enhance the sirtuin-1 enzyme that inhibits xanthine oxidase,  suppress pyrin domain-containing 3 inflammasome activation, and curb interleukin 1β secretion. SGLT2i use might also improve kidney function and heart failure and reduce the use of loop or thiazides diuretics, and thus indirectly lower the risk for recurrent gout flares.

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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Congenital hyperinsulinism (CHI) is a rare genetic disease that affects newborns and children resulting in persistent hypoglycemia due to the overproduction of insulin. Dasiglucagon is a glucagon analog formulated in a ready-to-use aqueous solution.

The Agency will conduct its regulatory review in 2 parts under the same NDA. Part 1 relates to dosing of up to 3 weeks, whereas Part 2 relates to the use beyond 3 weeks. The application is supported by data from 2 pivotal phase 3 trials (ClinicalTrials.gov Identifier: NCT04172441 [Trial 1]; NCT03777176 [Trial 2]) and an ongoing long-term extension trial (ClinicalTrials.gov Identifier: NCT03941236).

Trial 1 evaluated the efficacy and safety of dasiglucagon for subcutaneous (SC) infusion in a hospital setting in 12 children aged 7 days to 12 months with persistent CHI. Baseline intravenous (IV) glucose infusion rate (IV GIR) was reported to be 15.7mg/kg/min. Results showed that dasiglucagon met the primary endpoint reducing the need for IV glucose by 55% vs placebo. Moreover, 10 of the 12 children were able to wean off IV glucose for at least 12 hours, and 7 of the 12 children remained weaned off IV glucose at the end of the trial without concomitant pancreatic surgery.

Trial 2 evaluated dasiglucagon for SC infusion in a homecare setting in 32 children aged 3 months to 12 years with CHI. Results showed that dasiglucagon missed the primary endpoint of reducing hypoglycemia events per week vs standard of care alone. However, dasiglucagon in addition to standard of care using continuous glucose monitoring reduced the time in hypoglycemia (defined as glucose <70 mg/dL) by approximately 50% and reduced the number of hypoglycemic events by approximately 40% vs standard of care treatment alone.

The safety profile of dasiglucagon was well tolerated. The most common adverse events were skin reactions and gastrointestinal disturbances. 

A Prescription Drug User Fee Act target date of December 30, 2023 has been set for this application.

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Leqvio is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA. The phase 3 ORION-8 trial is an open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3. A total of 3274 patients with ASCVD, increased risk of ASCVD, HeFH and elevated LDL-C, took part in the ORION-8 trial. Patients from the 4 previous trials received inclisiran every 6 months for up to an additional 3 years.

Results showed that 78.4% (95% CI: 76.8, 80.0) reached their pre-specified LDL-C targets; less than 70mg/dL for patients with ASCVD, or less than 100mg/dL for patients with increased risk of ASCVD. The average LDL-C level reduction was 49.4% (95% CI: 48.3, 50.4). Safety data was consistent with previous findings for inclisiran.

David Soergel, MD, Novartis’ Global Head of Cardiovascular, Renal and Metabolic Drug Development said, “The trial is part of a growing body of evidence for Leqvio being generated through our ongoing VictORION program that is examining the use of Leqvio in broad and varied patient populations affected by ASCVD.”

Earlier in 2023, the indication for Leqvio was expanded to include treatment of adults with primary hyperlipidemia to reduce LDL-C, as an adjunct to diet and statin therapy.

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Kurt Hager, Ph.D., from Tufts University in Boston, and colleagues used individual-level data from 22 produce prescription locations in 12 U.S. states from 2014 to 2020 to assess the impact on cardiometabolic health and food security outcomes.

The researchers found that after a median participation of 6.0 months, fruit and vegetable intake increased by 0.85 cups per day among adults and by 0.26 cups per day among children. Receipt of fruits and vegetables was associated with lower odds of being food-insecure (odds ratio [OR], 0.63) and higher odds of improving one level in self-reported health status for adults (OR, 1.62) and children (OR, 2.37). Glycated hemoglobin declined by −0.29 percentage points among adults with glycated hemoglobin ≥6.5 percent, while systolic and diastolic blood pressures declined by −8.38 mm Hg and −4.94 mm Hg, respectively, among adults with hypertension. Among adults with overweight or obesity, body mass index (BMI) declined by −0.36 kg/m² (−0.64 to −0.09), but child BMI z-score did not change −0.01 (−0.06 to 0.04).

“We know that food insecurity impacts health through several important pathways, including overall dietary quality, but also through stress and anxiety, mental health and tradeoffs between paying for food and other basic needs such as housing costs, utilities and medications,” Hager said in a statement. “These results indicate produce prescriptions may lay an important foundation for improved health and well-being.”

One author disclosed ties to the pharmaceutical industry.

Abstract/Full Text

Editorial

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Tirzepatide is the first dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) indicated for treating type 2 diabetes. This medication has been shown to reduce weight and other metabolic parameters among patients with diabetes. Researchers conducted a study to determine the safety and efficacy of weight reduction in patients taking tirzepatide. 

Data was collected from PubMed, Embase, and Cochrane databases and researchers searched for randomized control trials of tirzepatide and a placebo regimen. Interventions were required to last at least 12 weeks. Some exclusion criteria were nonrandomized studies, studies with an overlapping cohort, and the use of another weight-loss medication. 

The primary endpoints were the average body weight change from baseline and the average percent body weight change. 

There were 397 studies identified using the search strategy and, after exclusion, 6 studies were included in the final analysis. Of the 4036 patients included, 922 (22.8%) were assigned 5 mg of tirzepatide, 927 (23%) received 10 mg, 1025 (25.4%) received 15 mg, and 983 (24,4%) received the placebo regimen.

The average change in body weight from baseline revealed the following mean differences compared to placebo:

• 5 mg dose of tirzepatide: -7.7 kg (95% CI, -11.0 to -4.4; P <.001; I², 94%) 
• 10 mg dose of tirzepatide: -11.6 kg (95% CI, -18.8 to -4.3; P =.002; I², 99%) 
• 15 mg dose of tirzepatide: -11.8 kg (95% CI, -17.4 to -6.2; P <.001; I², 98%)

The average percentage change in weight in patients taking tirzepatide compared to the placebo group had the following mean differences:

• 5 mg dose of tirzepatide: -8.1% (95% CI, -11.0 to -5.2; P <.001; I², 92%)
• 10 mg dose of tirzepatide: -11.9% (95% CI, -18.1 to -5.6; P <.001; I², 98%)
• 15 mg dose of tirzepatide: -12.4% (95% CI, -17.2 to -7.5; P <.001; I², 97%)

Results also show that tirzepatide reduced body mass index (BMI) and waist circumference. Compared with placebo, tirzepatide had an increased risk of developing some common adverse effects, including nausea (odds ratio [OR], 4.2; 95% CI, 2.4-7.5; P <.001), vomiting (OR, 7.0; 95% CI, 4.3-11.4; P <.001), and diarrhea (15 mg dose; OR, 2.8; 95% CI, 1.6-4.9; P <.001).

Study limitations are a high heterogeneity in studies, variations in treatment durations, and differences in baseline weight and BMI between studies. 

“The drug’s risk-to-benefit with each dose should be evaluated in an individualized manner in clinical practice,” study authors stated. “Whether the substantial effects on weight loss and adiposity will lead to a significant cardiovascular risk reduction remains to be determined.”

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The observational study used data from the Korean Health Insurance Review and Assessment Service. Patients with type 2 diabetes aged 18 years or older were identified in the database, and those who received PCI for AMI from January 2014 to August 2018 were enrolled. Patients who received SGLT2 inhibitors for more than 7 consecutive days within 14 days after PCI for AMI were defined as the SGLT2 inhibitor group.

The primary endpoint was a composite of all-cause death and hospitalizations for HF. Secondary analysis of the ischemic endpoint was a composite of all-cause death, nonfatal MI, and nonfatal ischemic stroke.

After 1:2 propensity score matching for the participants with and without SGLT2 inhibitor use, 2814 patients were included (SGLT2 inhibitor group, 938 patients; no-use of SGLT2 inhibitors group, 1876 patients). Their mean age was 57.2 years, 80.0% were men, and the median follow-up was 2.1 years (IQR, 1.4-2.9).

At 2 years, early use of SGLT2 inhibitors was associated with a reduced risk for the primary endpoint compared with no use of SGLT2 inhibitors (9.8% vs 13.9%; adjusted hazard ratio [aHR], 0.68; 95% CI, 0.54-0.87; P =.002).

The SGLT2 inhibitor group had a significantly decreased incidence of all-cause death compared with the no-use of SGLT2 inhibitors group (3.7% vs 6.6%; aHR, 0.55; 95% CI, 0.37-0.80; P =.002). Participants who received SGLT2 inhibitors had a significantly decreased cumulative hospitalization rate for HF (7.4% vs 9.8%; aHR, 0.74; 95% CI, 0.56-0.98; P =.03).

Patients who received SGLT2 inhibitors had a significantly decreased rate of secondary endpoints compared with the no-use of SGLT2 inhibitors group (9.1% vs 11.6%; adjusted HR, 0.77; 95% CI, 0.60-0.99; P =.04), which was mostly attributable to the reduced incidence of all-cause death in the SGLT2 inhibitor group.

In the inverse probability of treatment weighting analysis, the SGLT2 inhibitor group had a decreased risk for the primary endpoint (12.5% vs 19.4%; aHR, 0.62; 95% CI, 0.54-0.78; P <.001).

The overall lower rate of the composite of all-cause death and HF hospitalizations for the SGLT2 inhibitor group were consistent in subgroups based on age, sex, medication, cardiovascular risk factors, and Charlson comorbidity index scores.

Limitations of the study include the retrospective nature and observational design, and prescription rates of SGLT2 inhibitors were low among the participants. Also, the average follow-up was limited, and the propensity-matched population is relatively young. Furthermore, the study does not have adequate data on the causes of death or total mortality.

“Taken together with the proven cardioprotective effects of sodium-glucose cotransporter 2 inhibitors, our results suggest that the use of sodium-glucose cotransporter 2 inhibitors could expand to the acute phase of acute myocardial infarction survivors with diabetes to reduce mortality and the subsequent development of congestive heart failure,” the study authors concluded.

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Maureen Sanderson, Ph.D., from Meharry Medical College in Nashville, Tennessee, and colleagues used data from 25,251 lower-income participants in the Southern Community Cohort Study (2002 to 2009 and 2012 to 2015) to explore the relationship between lifetime interpersonal violence or abuse and diabetes.

The researchers found that adult interpersonal violence or abuse was associated with an increased risk for diabetes (adjusted hazard ratio [aHR], 1.23; 95 percent confidence interval [CI], 1.16 to 1.30). Diabetes risk was also higher for childhood abuse and neglect. The combination of adult interpersonal violence or abuse and childhood abuse or neglect further elevated the risk for diabetes (aHR, 1.35; 95 percent CI, 1.26 to 1.45) versus experiencing no violence, abuse, or neglect. These associations were consistent for Black and White participants and for women and men.

“Our finding that lifetime interpersonal violence was associated with a significantly increased risk of developing diabetes across race and gender before the additional social stress of the COVID-19 pandemic strongly suggests the need for helping professionals across disciplines to implement effective violence prevention and intervention strategies to reduce the short- and long-term social and health consequences of partner violence and child abuse,” Sanderson said in a statement.

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To determine whether DR was superior to IR in people with diabetes and tissue loss for wound healing or preventing minor and major amputation and adverse events, researchers performed a systematic review of title and abstract searches conducted from 1980 to November 30, 2022. The study also aimed to determine whether endovascular revascularization was superior to open revascularization for wound healing or preventing minor and major amputation and adverse events. A total of 26 studies with 5190 participants compared DR and IR, while 11 studies with 28,182 participants who received an endovascular procedure and 9515 participants who received an open procedure were included in the review.

When comparing DR and IR, all studies reported a greater proportion of participants healed with a DR (66.9%-96.4%) than IR (54.6%-85.7%). For minor and major amputations, DR seemed to reduce the number of participants requiring amputations. For example, 3 of 4 studies reported fewer major amputations in those receiving DR (2.9%-13.4%) compared with those who received IR (9.2% to 27.2%).

However, IR with collaterals may reduce major adverse limb events similar to DR. IR with collaterals may also improve amputation-free survival at higher rates than IR and DR. Of the 4 studies that reported the outcome of mortality, 2 studies reported lower mortality in those receiving DR. The 2 other studies reported a nonsignificant difference between DR and IR in lowering mortality rates. The certainty of evidence was rated as very low in people with diabetes, PAD, and a foot ulcer on whether DR is superior to IR in healing, preventing amputations, preventing mortality, or increasing survival.

The certainty of evidence was moderate for open revascularization surgery being more effective than endovascular revascularization in preventing major adverse limb events or death. However, evidence is low to support whether endovascular revascularization is more effective to open or hybrid revascularization to heal a foot ulcer or prevent minor or major amputations in people with diabetes, PAD, and tissue loss.

Study limitations include the evidence not being captured during the search, the researchers not being contacted for unpublished studies, and the data lacking suitability for meta-analysis, which limits the interpretation of the study.

“The findings of this review highlight the limited evidence comparing outcomes for DR and IR and endovascular and open revascularisation for diabetes‐related foot disease, including healing and amputation,” the researchers wrote.

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James L. Januzzi, M.D., from Massachusetts General Hospital in Boston, and colleagues measured concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T, growth differentiation factor-15, and insulin-like growth factor binding protein 7 (IGFBP7) in 2,627 participants in the Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation trial. The effect of canagliflozin was assessed on biomarker concentrations. The prognostic potential of each of the biomarkers was examined on the primary outcome (composite of end-stage renal disease, doubling of serum creatinine level, or renal death or cardiovascular death).

The researchers found that the biomarkers increased by 6 to 29 percent in the placebo arm and by 3 to 10 percent in the canagliflozin arm at one year. Cardiac and renal outcomes were strongly predicted by baseline concentrations of each biomarker. When the biomarkers were analyzed together in a multimarker panel, individuals with high- and moderate-risk scores had a higher risk for the primary outcome compared with those with low-risk scores (hazard ratios, 4.01 and 2.39, respectively). A 50 percent increase in NT-proBNP, high-sensitivity cardiac troponin T, growth differentiation factor-15, and IGFBP7 at one year were associated with risk for the primary outcome (hazard ratios, 1.11, 1.86, 1.45, and 3.76, respectively).

“It was reassuring to discover that canagliflozin helped reduce risks the most in people with the highest chances for complications,” Januzzi said in a statement.

Several authors disclosed ties to the pharmaceutical and medical device industries, including Janssen Research & Development, LLC, which funded the trial and analysis, and Roche Diagnostics, which provided reagents.

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Researchers conducted a longitudinal cohort study between 2013 and 2022 using data captured from adult patients with HIV infection and no history of excessive alcohol consumption or hepatitis coinfection. The researchers aimed to evaluate the connection between NAFLD (with or without NASH) and the risk for new-onset type 2 diabetes. They also assessed whether progression to NAFLD increases the risk for type 2 diabetes and whether tenofovir alafenamide (TAF) and integrase strand transfer inhibitor (INSTI) use is associated with increased risk for NAFLD or NASH. The primary outcome was new-onset type 2 diabetes; secondary outcomes included incident NASH and incident NAFLD.

A total of 847 patients were included in the study, of whom the median age was 45 (IQR, 38-51) years at baseline, and 43% were women. At enrollment, the median CD4⁺ count was 584 (IQR, 440-753) cells/mm³, the median BMI was 22.6 (IQR, 20.7-25.1) kg/m2, 28% of patients had NAFLD, 15% had NASH, and 6% were receiving TAF-based antiretroviral therapy (ART).

During a follow-up period of 2552 person-years, the overall incidence of type 2 diabetes was 10.9 (95% CI, 7.5-15.9) per 1000 person-years. The incidence of type 2 diabetes per 1000 person-years was higher among patients with (incidence rate [IR], 22.0; 95% CI, 13.6-36.3) vs without (IR, 6.5; 95% CI, 3.7-1.1) NAFLD at baseline (log-rank P <.001).

The researchers performed a multivariable Cox regression analysis, adjusting for age, sex, BMI, smoking status, duration of ART use, dyslipidemia, hypertension, and family history of diabetes, among other variables. Results showed that the risk for type 2 diabetes was increased among patients with NAFLD with or without NASH compared with those without NAFLD at baseline (adjusted hazard ratio [aHR], 2.83; 95% CI, 1.26-6.36).

Further analysis showed that baseline NAFLD plus NASH with significant disease activity and liver fibrosis were significantly associated with new-onset type 2 diabetes (aHR, 3.12; 95% CI, 1.05-9.26). Although not significant, the risk for type 2 diabetes was also increased among patients with NASH alone.

Predictors of incident NASH included obesity, (aHR, 4.50; 95% CI, 1.95-10.36), receipt of ART for at least 10 years (aHR, 2.31; 95% CI, 1.12-5.11), and TAF use (aHR, 2.31; 95% CI, 1.12-5.11). Predictors of incident NAFLD included obesity, dyslipidemia, liver stiffness measurements of 7.5 kilopascals and above, and TAF use (aHR, 2.01; 95% CI, 1.02-4.02).

Study limitations include potential selection bias and the inability to control for unmeasured confounders such as genetic variants, lifestyle, and diet. These results may not be generalizable to other populations as all study patients were of Thai or Asian ancestry.

Based on these findings, “The presence of severe liver disease (NASH) amplifies the risk of new-onset DM [diabetes mellitus] for PWH [people with HIV] with NAFLD,” the researchers concluded.

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

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Investigators sought to develop a globally applicable healthy diet score associated with health outcomes. The primary outcomes were all-cause mortality and major cardiovascular events (cardiovascular disease [CVD]).

They conducted an observational study and meta-analysis using a healthy diet score developed from almost 147,642 people in the general population in 21 countries (the PURE study) with the aim of replicating the results in 3 independent studies (n=43,834 in 50 countries) and in 2 case-control studies of myocardial infarction (n=26,191 in 52 countries) and stroke (n=26,930 in 33 countries). Overall, these 6 studies included patients (N=244,597) from 80 countries.

The PURE study developed a healthy diet score (range, 0-6) based on the following 6 foods:

• Fish
• Nuts
• Vegetables
• Fruits
• Legumes
• Dairy (primarily whole-fat)

In the PURE study, the median follow-up was 9.3 years (IQR, 7.5-10.8) and a diet score of at least 5 was associated with lower risk for CVD (hazard ratio [HR], 0.82; 95% CI, 0.75-0.91), mortality (HR, 0.70; 95% CI, 0.63-0.77), stroke (HR, 0.81; 95% CI, 0.71-0.93), and myocardial infarction (HR, 0.86; 95% CI, 0.75-0.99).

The mean PURE Healthy Diet Score was 2.95 (SD, 1.50), with the highest median diet scores by region found in Europe, North America, South America, and Middle East. South and Southeast Asia, Africa, and China had lower scores and lower intake of the 6 component foods (higher per capita gross national income associated with higher healthy diet scores [P_trend <.0001]).

In the PURE study, the least healthy diet (scores ≤1) had lower amounts of each of the 6 healthy foods compared with the healthiest diet scores (≥5). The least healthy diet vs the healthiest diet corresponds to high carbohydrates, lower fat, lower protein, lower red meat, and lower poultry.

Among patients with vascular disease in 3 independent studies, the investigators found similar results, with higher diet scores associated with statistically significant lower CVD (HR, 0.79; 95% CI, 0.72-0.87), mortality (HR, 0.73; 95% CI, 0.66-0.81), and myocardial infarction (HR, 0.85; 95% CI, 0.71-0.99). There was also a nonstatistically significant lower risk for stroke (HR, 0.87; 95% CI, 0.73-1.03).

Among patients in 2 case-control studies, higher diet scores were associated with lower risk for stroke (odds ratio [OR], 0.57; 95% CI, 0.50-0.65) and first myocardial infarction (OR, 0.72; 95% CI, 0.65-0.80).

In regions with lower gross national incomes, a higher diet score was associated with significantly lower risk of CVD or death (P_{heterogeneity} <.0001). Slightly stronger associations with CVD or death were reported with the PURE score vs several other common diet scores (P <.001 for each comparison).

Study limitations include the observational design, self-reported diet data, and unexamined role of individual fruits and vegetables.

“Lower consumption of healthy foods including fruits, vegetables, nuts, legumes, fish, and dairy (i.e. a lower PURE diet score), contributes to an increase in cardiovascular risk globally, especially in countries with lower income,” the investigators wrote. “This was consistent in individuals with or without vascular disease, and in all world regions, especially in countries with lower income.”

Disclosure: This research was supported by major contributions from AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, and GlaxoSmithKline, and additional contributions from Novartis and King Pharma.

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