Year of Exenatide Treatment Improves Baseline A1c Levels in Diabetic Patients

Minneapolis—In a single-arm, multicenter, observational study of patients in the United States with type 2 diabetes (T2D), twice-daily administration of exenatide was associated with significantly lower glycosylated hemoglobin (A1c) test results and reductions in weight and body mass index (BMI) 12 months after enrollment. Findings were reported at a poster presentation at the AMCP meeting in a poster titled Exenatide BID Observational Study: Results for Primary and Secondary End Points at 12 Months. The authors said data on the effectiveness of exenatide in this real-world study were consistent with outcomes data from previously reported clinical trials and retrospective reviews. A total of 452 patients treated at 74 facilities across the nation took part in the year-long study. Most participants (60%) were women, and the mean patient age was 55 years. At baseline, a significant proportion of patients had ≥1 comorbidity. Of the comorbidities prevalent in >10% of study participants, hypertension (61.5%) was the most common, followed by hyperlipidemia (47.1%) and neuropathy (12.2%). The primary objective of this study was to increase the proportion of patients with an A1c ≤7.0 or with an absolute drop in A1c ≥0.5% from baseline at 12 months. The goal for patients who had an A1c ≤7.0 at enrollment was to maintain this level, which is associated with good glucose control in most individuals with T2D. Reductions in waist circumference, blood pressure, BMI, and lipid levels were a few of the secondary end points. Median A1c at baseline was 7.96%. This was reassessed at 3, 6, and 12 months, along with various lipid levels, blood pressure, and measures used to assess obesity. Patients completed questionnaires on quality of life (QOL) and eating habits at baseline, and these were repeated at 6 and 12 months. Following 3 months of exenatide therapy, median A1c showed a drop of 0.71% from baseline in a subset of 179 patients for whom data were available. It was down by 0.64% in the 186 patients with 6-month follow-up data and by 0.80% in the 118 patients retested at 12 months. As of 3 months, 74.3% of the 179 patients evaluated had attained the study’s A1c goal; at baseline, only 33.0% of this cohort had an A1c ≤7.0. The proportion of patients who met the A1c goal at 6 months dropped slightly compared with the 3-month assessment, to 71.0%, but the size of the cohort increased to 186 patients. At the study’s conclusion, 12-month evaluations for a subset of 118 patients demonstrated that 76.3% had achieved the study’s primary end point. Only 46.0% of the original 452 patients remained on exenatide at 12 months. The leading reasons for therapy discontinuation were “lost to follow-up” and “patient decision” (15.9% and 10.6%, respectively). Looking at 12-month outcomes data for cohorts that ranged from 92 to 114 patients per item assessed revealed improvements on every clinical measure and all QOL criteria. In addition, the eating questionnaire showed perceptions about eating were better across the board and satiety after meals had risen. The authors note that diabetes and its related complications already impose a serious burden on healthcare costs in the United States, accounting for 10% of all medical expenditures. Rates of diabetes are climbing, a trend expected to continue, making the availability of clinically effective treatments paramount. This study was sponsored by Amylin Pharmaceuticals, Inc and Eli Lilly and Co.