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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 Car
Date:9/1/2013

AMSTERDAM, The Netherlands and OSAKA, Japan, Sept. 2, 2013 /PRNewswire/ -- 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.

"There is a need for safer glucose lowering therapies in patients with diabetes who are at an elevated risk for cardiovascular disease," stated William B. White, MD, FASH, FAHA, FACP, principal investigator of the EXAMINE trial. "Given the EXAMINE study design and high-risk patient population evaluated, these results provide key insights to clinicians treating diabetes patients with coronary disease."

The global EXAMINE trial is an im
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SOURCE Takeda Pharmaceutical Company Limited
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