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Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA® Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia®
Date:11/17/2010

Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "Our EXSCEL cardiovascular outcomes study will further explore this area and the role of exenatide."

EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is designed to determine if there are favorable cardiovascular effects of exenatide treatment, using the investigational product BYDUREON™ (exenatide extended-release for injectable suspension), compared to standard of care with traditional diabetes medications. The study is underway and will include approximately 9,500 patients, with results expected as early as 2016.

Study Design and Findings

The study presented today was designed to assess the relative incidence rate of first CVD-related events in a real-world setting among adult patients with type 2 diabetes. Analyses included patients initiating a new prescription for a diabetes therapy between June 1, 2005, and March 31, 2009, without a prescription for the same agent in the prior nine months. Patients were followed until one of the following occurred: CVD event (acute myocardial infarction, stroke or coronary revascularization procedure), insurance disenrollment or study end. An intention-to-treat analysis of CVD events was adjusted for more than 300 potential differences in clinical and demographic characteristics using propensity-score-weighted methods.

Based on the hazard ratio (HR) and 95 percent confidence interval (CI), BYETTA-treated patients were less likely to have had a CVD event than patients treated with insulin (HR=0.72; CI, 0.66-0.79; P less than 0.0001), TZDs (HR=0.92; CI, 0.85-1.00; P less than 0.05) or sulfonylureas (HR=0.91; CI, 0.83-0.99; P less than 0.05); they were equally likely to have had a CV event compared to patients treated with Januvia (HR=1.00; CI, 0.9-1.12; P greater than 0.05) or metformin (HR=1.01; CI, 0.93-1.09; P greater than 0.05). BYETTA-treated patients had a significantly lower inciden
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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