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Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009
Date:6/8/2009

g with diabetes have two- to four-times greater risk of cardiovascular disease compared to people who don't have diabetes, we are comforted to have data that showed patients treated with BYETTA had no increased risk of cardiovascular events and that BYETTA may offer a potential cardiovascular benefit."

Study Design and Findings

In this integrated analysis, 2,316 BYETTA subjects and 1,629 pooled comparator subjects were treated for a total of 1,072 and 780 patient-years of exposure, respectively. The unadjusted incidence of experiencing at least one CV event was 2.0 percent for BYETTA and 2.6 percent for pooled comparator; the relative risk between BYETTA and pooled comparator was 0.69 (95 percent confidence interval: 0.46-1.03). The Exposure Adjusted Incidence Rate (expressed as per 1,000 patient years) was 43.4 for BYETTA and 54.4 for pooled comparator with a relative risk 0.80 (95 percent confidence interval: 0.53-1.21). CV events included stroke, myocardial ischemia, myocardial infarction, cardiac mortality, arrhythmia, revascularization procedures and congestive heart failure.

About Diabetes

Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and results in approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve an
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SOURCE Amylin Pharmaceuticals, Inc.
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