Diabetes Drug Avandia: Heart Risk?
Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed
Avandia Benefit, Avandia Risk continued...
But none of the trials on which Avandia was approved showed that the drug actually prevented the greatest threats to people with diabetes: microvascular problems, heart disease, or heart death.
In a strongly worded editorial accompanying the study, University of Washington researcher Bruce M. Psaty, MD, PhD, says the Nissen study means there's no good reason for most patients to take Avandia.
"There is little evidence for using this drug," Psaty tells WebMD. "The purpose of reducing blood sugar is to prevent cardiovascular events. Now the possibility of cardiovascular benefit associated with Avandia appears remote -- indeed, it appears linked to harm. So the rationale for prescribing it at this time is just not clear."
Psaty warns patients taking Avandia not to just stop using it. They should continue taking the drug until they can discuss the matter with their doctor.
"This is not an immediate risk. It is the absence of an expected benefit and the possibility of harm over the years," he says. "Patients should talk with their doctors and see if they are getting the benefit they expected. Doctors can look at the data and say whether there is a compelling reason for them to prescribe this drug. I don't think there is."
Avandia Safe, GlaxoSmithKline Says
GlaxoSmithKline has done its own analysis of Avandia's heart safety data. Using techniques similar to those used in the Nissen study, the GSK study showed about a 30% increase in heart risk to patients taking Avandia.
But a study of 33,000 patients in a managed-care database showed no increased heart risk in patients taking Avandia. Both this study and the GSK analysis were given to the FDA in August 2006.
Ongoing, long-term studies also support Avandia safety, says GSK chief medical officer Ronald Krall, MD.
"I want to be very clear that we are confident in the benefit/risk profile for Avandia. We believe that if it is used according to the directions incorporated into U.S. and European labels, it is an important treatment for patients with type 2 diabetes," Krall says in a news release. "We believe that important evidence coming from long-term studies supports the safety of Avandia."