For Bristol-Myers Drug, Condition Is Critical

Pargluva is designed to treat Type 2 diabetes, the most common form of the disease, in which the body doesn't make enough insulin to turn sugar into fuel for the body's cells. If this happens, too much sugar remains in the blood. The drug is a member of a drug class known as dual peroxisome proliferators-activator receptor agonists, or PPAR. So far, none of these experimental drugs has come to market.

An FDA advisory committee in September approved Pargluva by an 8-1 vote as a stand-alone treatment for Type 2 diabetes. The panel also recommended that Pargluva could be used with metformin, sold as Glucophage by Bristol-Myers.

Metformin helps control blood sugar by decreasing the amount of glucose absorbed from food and the amount of glucose made by the liver. The panel acted despite some concerns among physicians and analysts about potential cardiovascular risks.

Earlier this month, researchers from the Cleveland Clinic said the drug shouldn't be approved without extensive, additional testing because of its heart risks.

Compared with patients taking a placebo or another diabetes drug, Pargluva patients had an "excess incidence" of death, heart attack, stroke and congestive heart failure, the researchers wrote in an article in the Journal of the American Medical Association.

Their research was based on reviewing five clinical trials. "This agent should not be approved ... until safety is documented in a dedicated cardiovascular events trial," they concluded.