FDA Board Suggests Warning for Gliptins

The drugs, used to stimulate insulin production, could cause problems for those at risk of heart disease.



A U.S. Food and Drug Administration advisory board recommended updated warning labels for heart patients taking the diabetes oral medications Saxagliptin and Alogliptin, according to a Medscape Medical News report. The decision is based upon studies presented in the New England Journal of Medicine which presented data suggesting that it was difficult to rule out increased risk of heart failure with these drugs. The drugs in question are commonly called gliptin DPP-4 inhibitors, or gliptins for short.

Gliptins can be combined with metformin or taken separately, and are generally regarded as safe. Metformin works by increasing insulin sensitivity and decreasing the release of glucose from the liver, thereby controlling blood glucose concentrations. Gliptins are one of several classes of drugs that work by stimulating the pancreas to produce more insulin.

People with diabetes are at greater risk of heart and vascular disease than the general population. In 2008, the FDA and the European Medicines Agency simultaneously revised their approval processes for all new glucose-lowering therapies to require a demonstration of cardiovascular safety. While metformin and glyburide have been subjected over a number of years to patient studies to assess risk to the heart and blood vessels, the newer gliptin medications have not been vetted to the same extent. This, along with ongoing development of new gliptin formulations, appear as the rationale underlying the FDA’s note of caution.

There’s nothing to suggest that gliptins are not a useful and reliable tool for Type 2 glucose control, but few drugs are appropriate for all patients. Those who have heart disease or who may be at heightened risk of heart disease should discuss the possibly heightened risks of side effects with their medical providers. Scientists hope more data studying gliptins and heart health in the coming years will provide a clearer picture of the drugs’ cardiovascular safety.

Saxagliptin is produced by Bristol-Meyers Squibb / AstraZeneca under the brand name “Onglyza” and Alogliptin is produced by Takeda Pharmaceutical Ltd. under the brand name “Nesina.”

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Jim Cahill is a senior writer for Insulin Nation and Type 2 Nation. Before turning to writing, he was a lawyer in government and private practice who focused on consumer protection and regulatory law. He can be contacted at jcahill@epscomm.com.