ORLANDO, Fla., June 26, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular (CV) events associated with SYMLIN® (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.
The meta-analysis included five completed, randomized, controlled clinical trials of 16 to 52 weeks' duration, and was based on the U.S. Food and Drug Administration's (FDA's) recent guidance for evaluating CV risk in new type 2 diabetes agents. The primary endpoint for this analysis was occurrence of primary major adverse CV events (MACE). The 95 percent confidence interval for the estimated risk ratio for the primary endpoint was 0.55 to 1.34. With the upper limit below the FDA-specified threshold of 1.8, this suggests that there is no increase in CV risk associated with SYMLIN use.
"People with diabetes are two to four times more likely to develop cardiovascular disease because of increased risk factors such as high blood pressure, lipid disorders and obesity," said Orville G. Kolterman, M.D., senior vice president, chief medical officer at Amylin. "SYMLIN is an important tool for many patients who struggle to achieve their glucose control targets, despite their best efforts with insulin. These safety analyses confirm our findings from individual clinical studies and provide additional insight into the CV safety prof
|SOURCE Amylin Pharmaceuticals, Inc.|
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