New research shows that in head-to-head trials, GlaxoSmithKline’s embattled diabetes drug Avandia is just as safe the competition—Takeda’s Actos. A trial of 36,000 patients by WellPoint proved that the risk of adverse reactions, such as heart attack and failure were about 4 percent in patients taking both treatments.
The study tracked patients for four years, examining adverse reactions during and after treatment.
"Within the commercially insured population that we assessed, we did not see a difference between the two agents," Mark Cziraky, a vice president at HealthCore who contributed to the study, told Fox News.
An FDA advisory committee, last month, recommended more restrictions on the drug due to increased risk of heart problems. GSK argued from the beginning that Avandia was being singled out and certain negative trials were being cherry picked and displayed to prove that the drug is a detriment to patients, while more positive trial data was ignored.
Takeda has stayed clear of this controversy reaping the rewards of the negative publicity surrounding Avandia—until now. The new data might put Actos at risk of the same fate looming over GSK’s blockbuster treatment. Obviously, Takeda disagrees.
“Actos offers an established safety profile regarding the risk of cardiovascular events in living with Type 2 diabetes,” Takeda spokesperson Hisashi Tokinoya told Bloomberg on Wednesday. “Actos studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that Actos was associated with an increased risk of heart attack, stroke or death.”
Additionally, the WellPoint study, contradicted an earlier study, released in January, which stated that patients taking Avandia have a higher risk of death, heart failure, and stroke than those taking Actos.