New Diabetes Drug Seems Safe For Heart, Study Finds

Cardiovascular Outcome Studies in Diabetes Drugs Finally Arrive

Raz added that the diabetes drug also prevented the progression of microalbuminuria, a condition that occurs when a type of protein called albumin is spilling into the urine due to kidney damage. Two diabetes experts unconnected to the study said the findings should help ease the minds of patients and physicians. “The treatment of patients with diabetes has been challenging in recent years,” said Dr. Sripal Bangalore, director of research in the cardiac catheterization laboratory at NYU Langone Medical Center, New York City. “It is reassuring to see a mega trial . .
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Both trials turned up no evidence for the adverse cardiovascular events that some had feared. The bad news is that neither drug appeared to improve cardiovascular outcomes, though cardiovascular disease is the cause of death in most people with diabetes. SAVOR-TIMI 53 A total of 16,492 people with type 2 diabetes at high risk for a cardiovascular event were studied in SAVOR-TIMI 53 . Participants wererandomized to the DPP-4 inhibitor saxagliptin (Onglyza, Bristol-Myers Squibb Bristol-Myers Squibb and AstraZeneca AstraZeneca ) or placebo.
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Furiex Confirms Alogliptin Cardiovascular Safety Outcomes Trial (EXAMINE) Met Primary Endpoint

The trials 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.
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