Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers

Background Dyslipidemia and type 2 diabetes are two of the most significant risk factors for the development of cardiovascular disease. Measurement of lipoprotein subclasses provides important information about derangements in lipid metabolism and helps refine cardiovascular risk assessment. Exenatide, a glucagon-like peptide 1 receptor agonist, improved glycemic control, obesity, hypertension, and dyslipidemia in patients with type 2 diabetes in clinical trials. Methods In the DURATION-1 trial, patients with type 2 diabetes were treated with exenatide once weekly or twice daily for 30 weeks. This post hoc analysis evaluated the impact of exenatide on lipoprotein subclasses in 211 DURATION-1 patients using vertical auto profile methodology and the Statistical Package for the Social Sciences general linear model adjusted for glycosylated hemoglobin (HbA1c) and weight. Results Baseline lipids and high sensitivity C-reactive protein were normal overall based on the standard lipid panel. Once-weekly exenatide reduced apolipoprotein B and the apolipoprotein B to apolipoprotein A1 ratio (P \u3c 0.05), independent of glycemic improvement and weight loss. A significant shift in lipoprotein pattern away from small, dense low-density lipoprotein-4 cholesterol was also observed (P \u3c 0.05). Exenatide once weekly increased high-density lipoprotein-2 cholesterol, even after adjustment for changes in HbA1c and weight (P \u3c 0.05). Triglycerides, very low-density lipoprotein cholesterol, and high sensitivity C-reactive protein were reduced with both the once-weekly and twice-daily exenatide regimens (P \u3c 0.05). Conclusion In this post hoc analysis, exenatide significantly improved a number of cardiovascular risk markers. Continuous exenatide exposure with exenatide once weekly elicited a greater response than did immediate-release exenatide twice daily, generally independent of glycemic improvement and weight loss. Thus, in addition to improving glycemic control, exenatide induced favorable changes in lipid and lipoprotein metabolism and decreased systemic inflammation

Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study

BackgroundDespite the increasing prevalence of obesity, the use of pharmacotherapy treatment remains low. Telehealth platforms have the potential to facilitate access to pharmacotherapy interventions, but little is known about telehealth patients. ObjectiveThis study describes a large patient population taking Plenity, an oral superabsorbent hydrogel (OSH) used in the treatment of excess weight or obesity (BMI 25-40 kg/m2). The analysis compared differences in weight loss practices and in-person access to obesity care among telehealth patients with preobesity and obesity. MethodsThis was a cross-sectional assessment of a random sample of 20,000 telehealth patients who completed a structured, web-based visit and received at least one prescription of OSH. Patients were eligible to receive care via telehealth if they were adults, were not pregnant, and had a BMI ≥25 kg/m2. During the visit, patients provided baseline health information including comorbidities, diet, and exercise habits. Their zip code of residence was used to determine their proximity to an obesity medicine provider. Descriptive statistical analysis and tests of differences (chi-square and 2-tailed t tests) were used to compare patients with preobesity (BMI 25-29.9 kg/m2) and obesity (BMI 30-40 kg/m2). ResultsMost (15,576/20,000, 77.88%) of the cohort were female, with a mean age of 44 (SD 11) years and a mean BMI of 32.4 (SD 4.1) kg/m2. Among the cohort, 32.13% (6426/20,000) had preobesity, and 40.18% (8036/20,000) of all patients had ≥1 weight-related comorbidity. Almost all (19,732/20,000, 98.66%) patients attempted 1 weight loss method before OSH and half (10,067/20,000, 50.34%) tried ≥4 different methods. Exercise and low-calorie diets were the most attempted weight loss methods, and 28.76% (5752/20,000) of patients reported a prior prescription of weight loss medication. Patients with obesity were more likely than patients with preobesity to have previously tried commercial weight loss plans (7294/13,574, 53.74% vs 2791/6426, 43.43%; P90% of both sexes reporting the belief that excess weight negatively affected their health (14,247/15,576, 91.47% female participants, 4116/4424, 93.04% male participants). Moreover, 29.25% (5850/20,000) of patients lived in the same zip code and 85.15% (17,030/20,000) lived in the same county as an obesity medicine provider. ConclusionsData from this large patient cohort supports the potential for telehealth to provide prescriptive weight management treatment to a population seeking care. Patients with preobesity are an undertreated population who actively seek new weight management options. Female participants sought weight management treatment earlier in the disease continuum than males, despite reporting fewer comorbidities

A randomized, double-blind, placebo-controlled study of gelesis100: A novel nonsystemic oral hydrogel for weight loss

Objective: This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity. Methods: The Gelesis Loss Of Weight (GLOW) study was a 24-week, multicenter, randomized, double-blind, placebo-controlled study in patients with BMI ≥ 27 and ≤ 40 kg/m2 and fasting plasma glucose ≥ 90 and ≤ 145 mg/dL. The co-primary end points were placebo-adjusted weight loss (superiority and 3% margin super-superiority) and at least 35% of patients in the Gelesis100 group achieving ≥ 5% weight loss. Results: Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super-superiority. Importantly, 59% of Gelesis100-treated patients achieved weight loss of ≥ 5%, and 27% achieved ≥ 10% versus 42% and 15% in the placebo group, respectively. Gelesis100-treated patients had twice the odds of achieving ≥ 5% and ≥ 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug-naive type 2 diabetes had six times the odds of achieving ≥ 10% weight loss. Gelesis100 treatment had no apparent increased safety risks. Conclusions: Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile