Takeda EXAMINE Cardiovascular Safety Outcomes Trial of Alogliptin Met Primary Endpoint of Non-Inferiority Compared to Placebo in Addition to Standard of Care Showing No Increase in Cardiovascular Risk in Type 2 Diabetes Patients at High-Risk for Cardiovascular Events

02.09.2013

Clinical Data Published in the New England Journal of Medicine and Presented at the ESC Congress 2013

Amsterdam, The Netherlands and Osaka, Japan, September 2, 2013 – Takeda Pharmaceutical Company Limited (Takeda) today announced 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 CV events. These data, published in the New England Journal of Medicine (NEJM) and also presented at the ESC Congress 2013, 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 of 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 (in 11.3% of patients vs. 11.8% of patients during a median follow-up period of 18 months; hazard ratio, 0.96; one-sided repeated confidence interval [CI] bound, 1.16). Alogliptin is a dipeptidyl peptidase-4 inhibitor (DPP-4i) for the treatment of Type 2 diabetes in adults to improve glycemic control as an adjunct to diet and exercise.

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