A study concludes that patients taking the drug marketed under the brand name Onglyza (saxagliptin) were more likely to experience hospitalization for heart failure.

Hospitalization for heart failure may be in order when the cardiac muscle becomes so weakened that it can’t adequately meet the oxygenated blood supply needs of the body.

Heart failure can be brought on by other cardiovascular conditions such as hardening of the arteries or gradual internal plaque build-up within the arterial blood delivery system or high blood pressure. Type-2 diabetes itself presents challenges to heart health as a matter of course and is a primary concern when a new medication for the condition is commercially released.

The 2013 study which revealed the increase in rates of hospitalization for heart failure in Onglyza takers is known as SAVOR-TIMI-53. The hospitalization for heart failure rate elevated by a large margin but it did attract the attention of researchers.

The participants in the SAVOR clinical trial already were in a high-risk category for developing cardiovascular issues or they had had a history of cardiac events. The study’s data indicated that there was a 27 percent increase in the rate of hospitalization for heart failure. It also presented a picture of a probable overall increased chance of expiring from any cause.

A 2013 companion study known as EXAMINE was also published in the New England Journal of Medicine. The drug under investigation with this study was alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor drug with a similar mechanism of action as DPP-4 saxagliptin, the active ingredient in Onglyza.

The EXAMINE study followed 5,380 patients and it discovered a very small hazard increase of .6 percent in hospitalization for heart failure. Studying heart issues as it related to alogliptin was not the aim of the study, but the information helped to underscore and support the data from SAVOR.

An advisory committee within the U.S. Food and Drug Administration (FDA) was–after conducting a safety review of both studies–more concerned with saxagliptin products and indicated that they would hope for a label change with appropriate warning back in April of 2015.

A big question that remains is whether the risks of hospitalization for heart failure generate to the entire class of DPP-4 drugs or whether they are fairly concentrated with Onglyza. A third drug in this group that has been on the market the longest—sitagliptin—also had a trial whose results were presented for the first time in 2015. There was no data from the TECOS trial that revealed an increased risk for heart failure.

Have you or a loved one taken Onglyza or Kombiglyze XR and been hospitalized for heart failure or other cardiac event or condition? You may have a legal claim.