Diabetes Drug Avandia: Heart Risk?
Study Shows 43% More Heart Attacks With Avandia; Drugmaker Says Study Is Flawed
WebMD News Archive
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
"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."