(UPDATES with Glaxo comment in 10th paragraph)
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The diabetes drug Avandia failed to meet a study goal that looked at whether the drug could slow the progression of coronary atherosclerosis or plaque buildup in artery walls.
The study involving GlaxoSmithKline PLC's (GSK) Avandia and an older diabetes drug is scheduled to be presented Wednesday at the American Heart Association's annual meeting in New Orleans as part of a late-breaking clinical trial session.
Another study released earlier this year showed a similar drug Actos, by Takeda Pharmaceutical Co. (4502.TO), did stop the progression of plaque buildup in heart arteries among patients with type 2 diabetes, and doctors had been waiting for the similar study involving Avandia.
However, last month, new treatment recommendations from the American Diabetes Association and the European Association for the Study of Diabetes suggested doctors not use Avandia amid concerns the product might increase the risks for heart attacks.
Type 2 diabetes is characterized by high blood-glucose levels that result from the body's inability to use insulin. People with diabetes face higher risks of developing other health problems including heart disease. Researchers have been looking at whether certain diabetes drugs could slow the development of heart problems.
The Avandia study, known as APPROACH, involved 672 diabetic patients who were treated with Avandia or glipizide, an older diabetes drug that falls into a class of medications known as sulfonylureas. Avandia and Actos are designed to make the body more sensitive to insulin in order to help lower blood sugar while sulfonylureas work to stimulate the pancreas to release insulin.
All patients entering the study underwent an intravascular ultrasound to measure the amount of plaque volume on the arterial wall at study entry. Patients were randomized to either glipizide or Avandia, at varying doses, for 18 months. After 18 months, a second ultrasound was performed to determine the amount of change in coronary plaque volume.
While the study showed patients receiving Avandia had a small reduction in plaque build up and patients on glipizide had an increase in the amount of plaque in their arteries, the difference did not reach statistical significance meaning it could have been due to chance. The study did show that Avandia met a secondary study goal that used a different measure that compared patient arteries.
The study was led by Richard W. Nesto, the chairman of the division of internal medicine at Brigham and Women's Hospital in Boston. GlaxoSmithKline paid for the study.
In a statement, GlaxoSmithKline said it was "encouraged" by the study findings, because they suggest treatment with Avandia "may stall the progression of coronary atherosclerosis."
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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(END) Dow Jones Newswires
November 12, 2008 12:03 ET (17:03 GMT)

Publié le 12 novembre 2008 Copyright © 2008 Dowjones