EXAMINE Finds No Increased Risk of CV Events with Alogliptin for Diabetes Patients
The double-blind, non-inferiority Examination of Cardiovascular Outcomes with Alogliptin Versus Standard of Care (EXAMINE) trial randomized 5,380 patients from 49 countries to receive alogliptin or placebo along with standard-of-care treatment for type 2 diabetes and cardiovascular risk factors. The drug was given in daily doses of 25 mg, 12.5 mg or 6.25 mg, depending on each patient's kidney function.
Outcomes also were similar in both groups for the secondary endpoint: a composite of cardiovascular death, nonfatal MI, nonfatal stroke and urgent revascularization due to unstable angina. The incidence of hypoglycemia, pancreatitis, malignancy and dialysis was similar in both groups as well.
"The findings could guide clinicians to choose among the many anti-diabetic agents available when treating patients with type 2 diabetes and very high cardiovascular risk," said William B. White, MD, chair of EXAMINE's steering committee and professor of medicine at the University of Connecticut School of Medicine, Farmington.
"However, EXAMINE does not rule out longer-term benefits or risks of alogliptin with respect to cardiovascular endpoints, as the median duration of the trial was approximately 18 months," he adds.
The study was undertaken to satisfy U.S. Food and Drug Administration requirements that new diabetes drugs undergo clinical trials to rule out cardiovascular risks.
Keywords: Stroke, Uracil, Acute Coronary Syndrome, Follow-Up Studies, Pancreatitis, Diabetes Mellitus, Type 2, Risk Factors, Hypoglycemia, Glycated Hemoglobin A, Renal Dialysis, Incidence, Piperidines, United States Food and Drug Administration, Cardiovascular Diseases, Hypoglycemic Agents
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