Studies examine cardiac safety of two new diabetes drugs

Two studies published in the New England Journal of Medicine yesterday offered hope for doctors, patients and pharmaceutical firms concerned about the potential negative cardiovascular effects of new drugs designed to combat Type 2 diabetes.

A new class of drugs known as DPP-4 inhibitors did not appear to raise a patient’s risk of heart attack, stroke or cardiovascular death.

“This large cardiovascular outcome trial sets a new standard for examination of the safety of diabetes drugs,” Deepak L. Bhatt of Brigham and Women’s Hospital, one of the study’s authors, said in a statement.

One study followed more than 5,300 patients for 18 months as a part of the randomized study of the drug alogliptin. The other trial studied the effect of saxagliptin on more than 16,000 randomized patients who had a history of or were at risk for cardiovascular events and monitored them for two years.

The cardiac safety of glucose-lowering drugs has been the subject of keen interest in the pharmaceutical industry since December 2008, when the Food and Drug Administration issued new guidelines with specific requirements for heart-safe drugs before and after the approval of new antidiabetic drugs.

The saxagliptin study found more patients were hospitalized for heart failure compared with the placebo group, an unexpected issue that “deserves further study,” said study chairman Eugene Braunwald of Brigham and Women’s Hospital.