Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited (Takeda) announced top line results of the EXAMINE ( EXamination of C Ardiovascular Outco Mes: Aloglipt IN vs. Standard of Car E 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).
“The EXAMINE trial is an important evaluation as it assesses cardiovascular safety in patients known to be at high risk for cardiovascular disease,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “Cardiovascular disease is very common in patients with Type 2 diabetes and the results of this study provide clinicians with assurance that alogliptin is effective and well-tolerated in these patients, and does not adversely affect cardiovascular health outcomes.”
EXAMINE was a large, randomized, double-blind, placebo-controlled global clinical trial, designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care alone, in patients with type 2 diabetes and a recent ACS. During the trial, patients were randomly assigned to receive alogliptin or placebo in addition to standard of care medications for diabetes and CVD. A total of 5,380 patients were randomly assigned and followed for a median of 18 months and up to 40 months. The rate of premature discontinuation of the study drug was similar in the alogliptin and placebo groups. Patients also received high levels of standard of care for treatment of Type 2 diabetes and CV risk factors.