Glaxo diabetes drug raises heart risk in study
Another study has found evidence that certain diabetes drugs, especially GlaxoSmithKline’s GSK.L GSK.N Avandia, can cause heart attacks and death, but the company said the findings did not make scientific sense.
The Canadian researchers said older patients treated with the drugs, known as thiazolidinediones, TZDs or glitazones, had a significantly higher rate of death, heart attack and congestive heart failure and death.
The drugs, which include Glaxo’s Avandia and rival drug Actos, made by Takeda Pharmaceutical Co Ltd 4502.T, are well known to raise the risk of heart failure. And the U.S. Food and Drug Administration has said Avandia should carry a “black box” warning that it may cause chest pain or heart attacks.
Dr. Lorraine Lipscombe of the Institute for Clinical Evaluative Sciences in Toronto and colleagues evaluated the risks of congestive heart failure, heart attack and all-cause death associated with the use of Avandia, known generically as rosiglitazone, and Actos compared to other, older diabetes drugs.
They analyzed the medical records of 159,026 people aged 66 and older who were treated with diabetes pills for a median of 3.8 years, through March 2006. They found a 60 percent increased risk of congestive heart failure, a 40 percent higher risk of heart attack and a 29 percent higher risk of overall death among the patients who were taking Avandia alone. They did not see a higher risk for any of these for Actos.
Glaxo said the study had “significant limitations and generates misleading conclusions.”
It said other studies had looked at heart attacks and death as well in Avandia users. “The majority of these studies show that rosiglitazone is not associated with an increased risk of myocardial infarction (heart attack) compared to other anti-diabetic agents,” Glaxo said in a statement.
“As the authors state, patients on TZDs in their analysis may represent an older, select group of patients with advanced diabetes and therefore higher baseline risk for cardiovascular disease,” the company added.
It said that in Canada, Avandia is only prescribed for those patients who are not helped by older diabetes drugs known as metformin and sulfonylurea. “The rosiglitazone patients are therefore ones with higher baseline risk for cardiovascular disease,” the company said.
“This new study we have just seen today does not change FDA’s recommendations,” the U.S. Food and Drug Administration said in a statement, adding that the studies published so far are inconclusive and that doctors should take the potential risks into account.
source: www.reuters.com
