A newer generation of diabetes drugs targeting the genetic machinery inside cells has undergone phase 2 and 3 clinical trials in preparation for release to the general public. A similar class of drugs (PPAR-a agonists) has been around for years, but a newer subclass featuring the new drug, muraglitazar, has been voted to be approved by the FDA for treatment of type 2 diabetes. This new class of drugs is referred to as PPAR-y agonists.
An article appearing in the Journal of the American Medical Association (2005;294:2581-2586) reviews the results of the 5 clinical trials sponsored by the drug maker which are now required by the FDA to be publicly disclosed. Disturbingly though, is the fact that diabetic patients treated with muraglitazar experienced an excess incidence of adverse cardiovascular events like heart attacks, stroke, congestive heart failure, and ultimately death when compared with a placebo or a similar diabetes medication.
The authors state, "patients who are enrolled in clinical trials often constitute the lowest-risk strata of patients, and the real world exposure would likely substantially amplify the risk. Taken as a whole, these data demonstrate that it is likely that muraglitazar, if approved by the FDA, would constitute an unacceptable patient hazard." They conclude that this new diabetic drug treatment should not be approved until a dedicated study assessing cardiovascular outcomes is conducted and shows that the drug is safe. The goal of treating diabetic patients is to lower their risk of complications like heart attack, stroke and death. Why the FDA committee would vote 8:1 to approve such a drug is puzzling and furthermore places our society at undue risk.
Posted by Kristopher Foster on May 14, 2006 07:22 PM
