Avandia Heart Disease Debate Continues
Study Shows Heart Failure Risk but 'Inconclusive' Data on Diabetes Drug Avandia and Heart Attacks
July 5, 2007 -- Data on the type 2 diabetes drug Avandia's overall heart risks are "inconclusive," researchers reported today in The New England Journal of Medicine.
The researchers note that they can't tell yet if there is an association between Avandia and heart attacks or Avandia and heart disease in general.
However, the researchers report an association between Avandia and heart failure, with more than twice as many heart failure cases in patients taking Avandia vs. other types of diabetes drugs.
In June, the FDA announced that Avandia and another diabetes drug, Actos, will soon carry a "black box" warning about heart failure risk
An editorial published with the study urges patients not to stop taking Avandia on their own, but to talk with their doctor about Avandia's risks and benefits.
The Avandia-heart risk debate hit the headlines in May, when other researchers suggested that Avandia might increase the risk of heart attack and death due to heart disease. Avandia' maker, GlaxoSmithKline, has called those findings flawed.
Avandia and Heart Problems Studied
Today's journal report comes from the interim results of a six-year Avandia study sponsored by GlaxoSmithKline.
The interim results cover the study's first 3.75 years.
The data include 4,447 patients with type 2 diabetes in Europe and Australia who couldn't adequately control their blood sugar with the diabetes drugs metformin or sulfonylurea.
Half of the patients took Avandia and a combination of metformin and sulfonylurea. For comparison, the other patients took the metformin-sulfonylurea drug combination without Avandia.
The patients were 58 years old, on average. Apart from their diabetes, they were generally in good health.
The researchers included Philip Home, DM, DPhil, of England's Newcastle Diabetes Centre and Newcastle University. They tracked the patients' hospitalization or death from any cardiovascular problems.