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News Articles >> New Study Praising Avandia Called Insign..
New Study Praising Avandia Called Insignificant
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| April 10, 2008. By Gordon Gibb |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Los Angeles, CA: When a drug is vilified as much as diabetes drug Avandia has for the risk of heart attack, one could understand the zeal with which a manufacturer approaches any piece of seemingly good news. This most recent carrot came in the form of a small study, which appears to suggest that Avandia can slow the progression of atherosclerosis in diabetic patients who have undergone cardiac bypass surgery.
However, Dr. Steven Nissen, noted cardiologist and chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, says not so fast. "This was an intravascular ultrasound study, not a morbidity-mortality study," he said in a statement.
Dr. Nissen was the first to report the risk of heart attack associated with the controversial Avandia, risk that sent shockwaves through the diabetic community and reverberated in the media throughout the world. It was almost a year ago, in May of 2007, that
Dr. Nissen authored a report published in the New England Journal of Medicine that fingered Avandia for significant risk to the heart and kidney, not to mention fluid retention and weight gain.
Nissen wasn't alone. When a review panel convened July 30th of last year to debate the merits of Avandia (rosiglitazone) and whether it was prudent to keep the drug on the market Dr. David Graham, a drug safety reviewer with the US Food and Drug Administration (FDA) testified, "it's well established that rosiglitazone increases congestive heart failure."
A German study, the results of which were published just prior to the Avandia review panel last year, revealed, "Avandia could worsen the complications of cardiovascular disease, and that Avandia use does little to improve quality of life, or length of life."
Dr. Bernd Richter of Heinrich-Heine University in Duesseldorf noted that his study found evidence that Avandia produced similar reductions in blood sugar levels as that of other oral antidiabetes drugs. However, patients on an Avandia regimen gained up to 11 pounds on average and were twice as likely to suffer from edema, or swelling.
This latest study on Avandia, which is a drug used to treat Type 2 diabetes and is manufactured by GlaxoSmithKline, involved 193 patients with Type 2 diabetes who had undergone cardiac bypass surgery. Participants in the study, dubbed VICTORY (Vein Coronary Atherosclerosis and Rosiglitazone After Bypass Surgery) were randomly assigned Avandia, or a placebo.
Researchers concluded that after a time frame of one year, participants taking Avandia presented with better blood sugar control compared with those on placebo, and also demonstrated improved cholesterol levels, together with fewer signs of inflamed blood vessels and lower blood pressure. There was no significant difference in cardiovascular events between the two groups, according to researchers.
"The enrollment of high-risk cardiovascular patients with Type 2 diabetes in a placebo-controlled trial with rosiglitazone was found to have an acceptable safety profile."
But hold on just a minute. According to Dr. Nissen of the Cleveland Clinic, the results were insignificant and didn't conclusively show that Avandia was safe for patients.
"How exactly can they establish the safety of rosiglitazone in a short-term study with (fewer) than 100 patients receiving the drug," Dr. Nissen asks. Of the 193 trial participants fewer than 100 received Avandia. Echoing Dr. Nissen's comments was Dr. Gregg C. Fonarow, professor of cardiology at the University of California in Los Angeles. He agreed that the study was too small to make any valid claims about the safety of Avandia.
GlaxoSmithKline, which brought Avandia to market in 1999 and has been required to update product labeling several times throughout the years, stands behind the study.
Glaxo paid for it, too.
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