Is Pargluva On the Ropes?

Clinical Trials Turn Up Unfavorable Data Despite Recommendation to Approve

| Jan 1, 2006

It was the belle of the ball at last summer’s ADA Scientific Sessions in San Diego. Now it appears that muraglitazar (Pargluva) is clinging to life after a scathing report recently published by the Journal of the American Medical Association.

On September 9, 2005, a U.S. Food and Drug Administration advisory committee, by a vote of 8 to 1, recommended approval of Pargluva for use in controlling blood glucose levels in people with type 2 diabetes. The drug is a new kind of type 2 oral medication known as a PPAR alpha/gamma agonist, designed to improve both insulin resistance and diabetic lipid disorders. Bristol-Myers Squibb and Merck collaborated in the development of the drug.

Poses Heart Risk

According to phase 2 and 3 clinical trials data, however, researchers found disheartening results in diabetic patients treated with Pargluva. The data, released under public disclosure laws for the FDA advisory committee, found that the incidence of death, myocardial infarction (MI), and stroke was higher in type 2s taking Pargluva when compared to patients taking placebo.

A total of 3,725 patients were randomized to receive differing doses of Pargluva, Actos, or placebo as stand-alone therapy or in combination with metformin or glyburide. The trials ranged from 24 to 104 weeks.

The researchers found that death, MI and stroke occurred in 35 of 2,374 (1.47 percent) patients taking Pargluva compared with nine of 1,351 (0.67 percent) patients in the combined placebo and Actos treatment groups.

Safety Needs to Be Documented

“For the more comprehensive outcome measure that included transient ischemic attack and congestive heart failure, the incidence was 50 of 2,374 (2.11 percent) for [Pargluva] compared with 11 of 1,351 (0.81 percent) for controls,” write the researchers.

The researchers conclude that Pargluva “should not be approved to treat diabetes based on laboratory end points until safety is documented in a dedicated cardiovascular events trial.”

Partnership May Terminate

According to an October 27, 2005, press release from Bristol-Myers Squibb, “We and our partner, Merck & Co., Inc., have determined that to receive regulatory approval and to achieve commercial success, additional studies may be required, because the ongoing trials were not designed to answer questions raised by the FDA. The additional studies could take approximately five years to complete.”

The press release goes on to state that Bristol-Myers Squibb has also agreed to begin discussions with Merck to terminate the collaborative agreement.

“Bristol-Myers Squibb will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of [Pargluva].”

Journal of the American Medical Association, published online October 20, 2005
—Bristol-Myers Squibb, October 27, 2005

In data presented at the June 2005 ADA Scientific Sessions in San Diego, California, Pargluva, taken in 5 milligram doses, reduced triglycerides by 12.3 percent and increased HDL (good) cholesterol by 17.7 percent.

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