Furiex Confirms Alogliptin Cardiovascular Safety Outcomes Trial (EXAMINE) Met Primary Endpoint
MORRISVILLE, N.C.--(BUSINESS WIRE)--Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited (Takeda) announced top line results of the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial showing the primary endpoint of non-inferiority compared to placebo in addition to standard of care was met with no increase in CV risk in a Type 2 diabetes patient population at high-risk for cardiovascular events. These data, published in the New England Journal of Medicine (NEJM) and also presented at the ESC 2013 Congress, demonstrate that alogliptin does not increase CV risk in Type 2 diabetes patients at high risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS). The trial’s primary objective was to evaluate non-inferiority with respect to CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin and placebo groups (11.3% vs. 11.8% during a median follow-up period of 18 months; hazard ratio, 0.96; one sided repeated confidence interval bound, 1.16).