February 11th, 2014

FDA Investigating Heart Failure Risk Linked to Saxagliptin

The FDA said today that it is conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin, a dipeptidyl peptidase 4 inhibitor, is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, Bristol Myers-Squibb.)

The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53, in which more than 16,000 patients with type 2 diabetes were randomized to saxagliptin or placebo. The trial, presented last year at the European Society of Cardiology and published in the New England Journal of Medicine, found no significant difference in the composite endpoint of cardiovascular death, MI, or ischemic stroke. However, there was a significant excess in hospitalizations for heart failure in the saxagliptin group (3.5% vs. 2.8%, p=0.007).

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 and should discuss their 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.


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