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FDA Investigating Heart Failure Risk Linked to Saxagliptin — Physician’s First Watch

Medical News |
February 12, 2014

FDA Investigating Heart Failure Risk Linked to Saxagliptin

By Larry Husten

The FDA is investigating a possible increased risk for heart failure associated with the diabetes drug saxagliptin, the agency announced on Tuesday. The dipeptidyl peptidase-4 inhibitor is marketed as Onglyza and Kombiglyze XR.

The investigation stems from findings from the SAVOR-TIMI 53 trial, in which over 16,000 patients with type 2 diabetes were randomized to saxagliptin or placebo. The trial found no significant difference between the groups in the composite endpoint of cardiovascular death, myocardial infarction, or ischemic stroke. However, there was a significant excess in hospitalizations for heart failure with saxagliptin (3.5% vs. 2.8%).

The FDA said that it has requested trial data from the manufacturer and that it considers current information from the trial to be preliminary. The agency advised that patients should not stop taking the drug but should discuss concerns with their healthcare professionals. The investigation of saxagliptin is part of a broader investigation into the cardiovascular risk of all drugs for type 2 diabetes.

Adapted from CardioExchange

Reader Comments (1)

Uzma Majid Physician, Endocrinology

But the persons with established heart disease should not take saxa till proven.

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