The U.S. Food and Drug Administration (FDA) requested clinical trial data from AstraZeneca Plc’s widely used diabetes drug, saxagliptin, to investigate a possible association between the use of the type-2 diabetes drug and heart failure.
The request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. This data was published by NEJM in September and was supported by AstraZeneca and Bristol-Myers Squibb Co., with whom AstraZeneca co-developed the drug before buying all rights in a deal completed earlier this month.
The study did not find increased rate of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin.
The FDA said it asked for the trial data to be submitted by early March 2014, after which the FDA will analyze and publicly report the findings.
At this time, the FDA considers information from the NEJM study to be preliminary. Analysis of the saxagliptin clinical trial data is part of a broad evaluation of, all type 2 diabetes drug therapies and cardiovascular risk.
Type-2 diabetes is a disease in which there is a high level of blood sugar in the blood as the body does not make or properly use the insulin hormone.
Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type-2 diabetes. It works by increasing the amount of insulin produced by the body after meals, when blood sugar is high.
Heart-related problems, such as ones seen with GlaxoSmithKline’s Avandia drug, are a concern with diabetes medications, especially as diabetics also have an increased risk of heart issues.
Although all drugs carry side effects, sometimes the benefits do not outweigh the risks. If you or a loved one suffered cardiac problems from diabetic medications, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).