Avandia study raises more questions than it answers — MedCity Morning Read, June 8, 2008

A large clinical study of whether GlaxoSmithKline‘s Avandia diabetes drug is harmful to the heart has raised more questions than it answered, causing some doctors to call the study flawed, according to the Wall Street Journal (subscription required).

The latest clinical study — sponsored by Glaxo — showed that heart attack risk did not increase for Avandia takers, according to Reuters news service. However the study did confirm that Avandia doubles the risk of heart failure and even adds to the risk of bone fractures, Reuters said.

Safety concerns have dogged Avandia since 2007 when an analysis of the drug suggested that patients taking it could have heart attacks at a higher rate than patients taking other diabetes drugs, the Journal said.

That was when the Cleveland Clinic’s Dr. Steve Nissen did a pooled analysis of past clinical research, concluding that patients on Avandia had a 43 percent higher risk of having heart attacks, Reuters said.

Results from the current clinical trial will enable Glaxo to rebuff its critics on the heart attack front, Reuters said. The British drug company will submit results of the study to the U.S. Food and Drug Administration.

Keep an eye on Glaxo’s U.S. blog for its own take on the study.

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