Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented a...( Cardiovascular Safety and Potential B...),Health

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 livin
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