Glaxo's Diabetes Drug Avandia May Cause Significant Heart Attack Risk

Avandia Might Have Prevented Diabetes In Some Patients, But Is This Benefit Offset By The Risk Of Heart Problems?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 21, 2007 the Los Angeles Times published an Associated Press (AP) article entitled "Diabetes drug linked to heart attack risk" which broke the story about a new analysis of Avandia data that was published online earlier this same day by the New England Journal of Medicine (NEJM).  The new Avandia article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death", by Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., will appear in the June 14, 2007 print edition of the NEJM.

Avandia (rosiglitazone) is used to treat Type 2 diabetes; more than six million people worldwide have taken Avandia, which comes from GlaxoSmithKline, since it was approved by the FDA in 1999.  It now appears that while Avandia might have prevented diabetes in some patients, this benefit came at the increased risk of heart problems including heart attacks and death.

"Glaxo's Drug Disaster", a May 21, 2007 online piece by Forbe's Matthew Herper", has more in-depth reporting on this developing Avandia - heart attack story:

Steven Nissen, chairman of cardiology at the Cleveland Clinic, performed the analysis by combing through 42 already completed studies of Avandia. Nissen has become one of the most prominent drug safety advocates in the U.S. since he warned in 2001 that Merck's painkiller Vioxx caused heart problems. Vioxx was pulled from the market three years later.

Nissen began to worry about Avandia last September when he saw the results of a 5,000-patient clinical trial, called DREAM, that showed Avandia prevented diabetes. Despite this benefit, patients on Avandia were 37% more likely to have heart problems, although the result was not statistically significant.

The DREAM results were "very troubling," Nissen told Forbes.com at the time (see: "Glaxo's Faustian Pill"). In a December letter to The Lancet, the medical journal that published DREAM, he went further, saying the result raised "serious questions about the safety of this agent." Also in December, he became more troubled when another study, meant to show that Avandia worked better than either of two cheaper generic diabetes drugs, also pointed to increased heart problems.

In the same edition of the New England Journal of Medicine, drug-safety experts Bruce Psaty, of the University of Washington, and Curt Furberg, of Wake Forest University, wrote an editorial to the effect that there is no clear reason to prescribe Avandia at all, now, in light of the associated heart attack risk uncovered by Dr. Steven Nissen.

According to the May 21 AP article, GlaxoSmithKline had scheduled a news conference for later in the day to discuss the NEJM report about Avandia being linked to heart attack risks, and the FDA had no immediate comment on the NEJM Avandia article.