Amylin Pharmaceuticals, Inc. announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular (CV) events associated with SYMLIN(R) (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 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 recent guidance for evaluating CV risk in new type 2 diabetes agents.
The findings from this meta-analysis are further supported by an analysis of post-marketing reports, which have not revealed evidence of a signal for CV risk in an estimated cumulative exposure of 67,540 patient-years since the launch of SYMLIN in 2005.
