The primary endpoint was occurrence of primary major adverse CV events (MACE), including CV mortality, myocardial infarction, stroke, acute coronary syndrome hospitalization, and urgent revascularization procedures. The relative risk between the SYMLIN and pooled comparator groups was 0.86 (95 percent confidence interval: 0.55 “1.34). The hazard ratios for primary MACE ranged from 0.88 to 0.93, depending on the analysis method (95 percent confidence interval: 0.56 “1.38). Additional analyses of narrower and broader MACE definitions resulted in similar findings with the upper limit of the 95 percent confidence interval below 1.8 for most CV endpoints and analysis methods. These data suggest that SYMLIN treatment in patients with type 2 diabetes is not associated with an increased risk of CV adverse events.

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.

SOURCE Amylin Pharmaceuticals, Inc.