ABSTRACT
Background: Management guidelines for obesity suggest maintaining a minimum of 5% body weight reduction to help prevent or lower the risk of developing conditions such as hypertension and type 2 diabetes. However, achieving long-term weight control is difficult with lifestyle modification alone, making it essential to combine pharmacotherapy with diet and exercise in individual cases. Semaglutide 2.4 mg has demonstrated significant reductions in body weight and cardiometabolic risk factors in clinical trials, but information on outcomes in a real-world setting is limited. Objective: To assess changes in body weight and other clinical outcomes at 6-month follow-up among adults on semaglutide 2.4 mg in a real-world setting in the United States (US). Methods: Observational and retrospective cohort study of patients initiating treatment between 15 June 2021, and 31 March 2022, using a large US claims-linked electronic health record database. Results: Mean (±SD) body mass index (BMI) of the 343 patients included in the analysis was 37.9 ± 5.5 kg/m2. After 6 months, mean body weight change was -10.5 ± 6.8 kg (95% CI: -11.2; -9.8, p < 0.001) and mean percentage body weight change was -10.0% ± 6.6% (95% CI: -10.7; -9.3, p < 0.001). Most (79.0%) patients had ≥5% body weight reduction, 48.1% had ≥10% body weight reduction, and 19.0% had ≥15% body weight reduction. Among patients with available data, the mean change in HbA1c (n = 30) was -0.6% ± 1.2% (95% CI: -1.0; -0.1, p = 0.016) and nearly two-thirds of patients with prediabetes or diabetes at baseline reverted to normoglycemia. Mean reductions of -4.4 ± 12.3 mmHg (95% CI: -5.7; -3.0, p < 0.001) and -1.7 ± 8.4 mmHg (95% CI: -2.6; -0.7, p < 0.001) were observed in systolic and diastolic blood pressure, respectively (n = 307). Statistically significant reductions in mean total cholesterol (-12.2 ± 38.8 mg/dl [95% CI: -24.3 to -0.06, p < 0.049]) and triglycerides (-18.3 ± 43.6 mg/dl [95% CI: -4.7; -31.9, p < 0.009]) were also observed (n = 42). Conclusions: This study demonstrated the effectiveness of semaglutide 2.4 mg in reducing body weight and improving cardiometabolic parameters in adults with overweight or obesity in a real-world clinical practice setting, showing a significant mean body weight reduction and improvements in biomarkers like blood pressure and HbA1c over a 6-month period. These findings, aligning with previous clinical trials at comparable time points, highlight the clinical relevance of semaglutide as an effective therapeutic option for obesity.
ABSTRACT
Purpose: To demonstrate a need for improved health insurance coverage for anti-obesity medications (AOMs) by comparing clinical and economic benefits of obesity treatments to covered medications for selected therapeutic areas. Methods: Using a grey literature search, we identified and prioritized therapeutic areas and treatment analogues for comparison to obesity. A targeted literature review identified clinical and economic outcomes research across the therapeutic area analogues. Associated comorbidities, clinical evidence, indirect costs (ie, absenteeism and productivity loss), and direct medical costs were evaluated to determine the relative value of treating obesity. Results: Four therapeutic areas/treatment analogues were selected for comparison to obesity: smoking cessation (varenicline), daytime sleepiness (modafinil), migraines (erenumab), and fibromyalgia (pregabalin). Obesity was associated with 17 comorbidities, more than migraine (9), smoking (8), daytime sleepiness (5), and fibromyalgia (2). Economic burden was greatest for obesity, followed by smoking, with yearly indirect and direct medical costs totaling $676 and $345 billion, respectively. AOMs resulted in cost savings of $2586 in direct medical costs per patient per year (PPPY), greater than that for varenicline at $930 PPPY, modafinil at $1045 PPPY, and erenumab at $468 PPPY; pregabalin utilization increased costs by $924 PPPY. AOMs were covered by 10-16% of United States health insurance plans, compared to 45-59% for the four comparators. Conclusion: Compared to four therapeutic analogues, obesity represented the highest economic burden and was associated with more comorbidities. AOMs provide greater cost savings compared to selected analogues. However, AOMs have limited formulary coverage. Improved coverage of AOMs may increase access to these treatments and may help address the clinical and economic burden associated with obesity and its comorbidities.
ABSTRACT
INTRODUCTION: Academic detailing (AD) is an effective, evidence-based education outreach method of promoting clinician behavior change. Detailer feedback is important for program evaluation but is rarely systematically collected. The study's objective was to develop a measure capturing the detailer's perception of the effectiveness of an AD program. METHODS: A six-item measure with a five-level scale was initially developed from the literature review and expert panel consultation. Item constructs were usefulness, acceptability, feasibility, relevance, effectiveness of communication, and readiness to change. The measure was piloted, refined, and tested during an opioid-focused AD program that included two visits. The instrument structure was evaluated using exploratory factor analysis, measure reliability was assessed using item-item correlation (rho), corrected item-total correlation, Cronbach alpha (α), and item response theory. RESULTS: The initial six-item instrument demonstrated unidimensionality. The Cronbach α for the measure was 0.74 (visit 1) and 0.79 (visit 2); one item (relevance) was redundant (α = 0.73 and 0.79 when deleted) and therefore dropped. Items related to usefulness, acceptability, and readiness to change displayed high item-item correlation (rho ≥ 0.50) and contributed the most information and seemed to operate as a single scale (ie, "likelihood to change") based on item response theory analysis. Items related to feasibility and communication were slightly different constructs and should be reported separately. DISCUSSION: The five-item detailer assessment of visit effectiveness (the "DAVE") instrument provides a standardized approach to assess AD. Further study of its validity and broader use in other programs and educational outreach activities is encouraged.
