Cardiovascular Safety and Potential Benefits of Exenatide to be Prospectively Assessed in Large Outcomes Trial
NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a meta-analysis of cardiovascular (CV) events that showed no increased risk of CV events associated with BYETTA(R) (exenatide) injection use compared to a pooled comparator group treated with either placebo or insulin. This analysis applied the principles that were described in the U.S. Food and Drug Administration's (FDA's) guidance for evaluating CV risk in type 2 diabetes agents. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.
In the meta-analysis of 12 completed, randomized, controlled clinical trials of 12-52 weeks, the unadjusted rate at which patients experienced at least one CV event was 2.0 percent for BYETTA and 2.6 percent for the comparator group; the relative risk between BYETTA and the comparator group was 0.69 with a 95 percent confidence interval of 0.46-1.03.
'The data from this analysis are reassuring and consistent with clinical trial data that show favorable effects of exenatide on cardiovascular risk factors,' said Byron Hoogwerf, M.D., clinical research physician for Eli Lilly and Company. 'Amylin and Lilly intend to initiate a large cardiovascular outcomes trial to further evaluate safety and to determine if there are cardiovascular benefits of exenatide treatment.'
'Patient safety is of utmost concern at Amylin and Lilly,' said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. 'Given that people living 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.
