Diabetes Medication Tied to Heart Failure Risk

The FDA announced it was investigating a possible link between heart failure and saxagliptin, a relatively new medication used to treat type 2 diabetes.

An investigation was prompted following the results of the SAVOR-TIMI 53 clinical trial in which investigators assessed the cardiovascular safety and efficacy of the antihyperglycemic agent saxagliptin. The multicenter, double-blind trial randomly assigned more than 16,000 older adult patients with type 2 diabetes to receive either saxagliptin or placebo, followed them for a median of 2.1 years, and monitored for cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke.

Although saxagliptin did not increase or decrease the rate of ischemic events in these patients, the investigators observed a higher rate of hospitalization for heart failure in the saxagliptin group than in the placebo group (3.5% vs 2.8%; hazard ratio, 1.27; 95% confidence interval, 1.07-1.51; P=.007). Mean glycosylated hemoglobin (HbA1c) was 0.2% lower in the saxagliptin group than in the placebo group, and hypoglycemia was more common with saxagliptin (15.3% vs 13.4%; P<0.001).

During this follow-up time, physicians were permitted to control patients’ diabetes with other medications, including other antihyperglycemic agents.

In a drug safety alert, the FDA said that it considers the results of the study to be “preliminary,” and that the inquiry is part of a “broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.” The manufacturer is required to submit trial data to the FDA by early March for analysis. Findings will be publicly reported.

The complete results of the trial are published in the New England Journal of Medicine. The SAVOR-TIMI 53 trial was funded by AstraZeneca and Bristol-Myers Squibb.

- Allison Musante, ELS

References

Scirica BM, Bhatt DL, Braunwald E, et al; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317-1326.

Saxagliptin (marketed as Onglyza and Kombiglyze XR). Drug safety communication: FDA to review heart failure risk. http://www.fda.gov. Published February 11, 2014. Accessed February 14, 2014.