UPDATE 1-Actos protects heart; Avandia risks persist-studies
(Adds Glaxo comments)
CHICAGO, Sept 11 (Reuters) - The diabetes drug Actos cuts the risk of heart attack, stroke and death, but raises the risk of heart failure, according to one study published on Tuesday, while a second confirmed disputed findings that rival Avandia raises heart risks.
Actos, made by Takeda Pharmaceutical Co Ltd, lowered the risk of heart attack, stroke and overall death by 18 percent, researchers reported in the Journal of the American Medical Association.
But GlaxoSmithKline's Avandia increased the risk of heart attack by 42 percent and more than doubled the risk of heart failure in patients who took the drug for at least a year, the second study in the same journal found.
Both drugs already carry U.S. Food and Drug Administration "black box" warnings saying they may cause or worsen congestive heart failure, a chronic condition in which the heart fails to pump blood efficiently to the body's organs.
Dr. Michael Lincoff of the Cleveland Clinic in Ohio said the study showed that, while the drugs act in a similar way to help control diabetes, they do not have the same side effects.
Lincoff and colleagues analyzed pooled data on Actos from 16,390 patients enrolled in 19 clinical trials.
"What we can say about pioglitazone (Actos) is not only does it not have the detrimental effect that has been seen with rosiglitazone (Avandia), but it actually has a protective effect," Lincoff said in a telephone interview.
SAME CLASS
Both Actos and Avandia are in a class called thiazolidinediones, or glitazones, which help the body use insulin more effectively. They are among several classes of drugs that treat type-2 diabetes, which affects 194 million people worldwide.
Dr. Bob Spanheimer of Takeda Pharmaceuticals said the Cleveland Clinic analysis of Actos confirms the results of its own clinical trials.
"It gives physicians and patients confidence that they can use Actos for treating high blood sugar and insulin resistance," he said.
But Alastair Benbow, GlaxoSmithKline's European medical director, strongly objected to any conclusions based on the two studies.
"We believe that the totality of the evidence suggests that the two products have a comparable safety profile," Benbow said in a telephone interview.
The Avandia analysis, done by researchers at Wake Forest University, confirmed other findings that Avandia increased the risk of heart failure. But the study did not find Avandia worsened the risk of death. Continued...
