Avandia, Actos Raise Heart Risks For Older Diabetes Patients

-Wall Street Journal

12/11/2007 - Older patients treated with diabetes drug Avandia, sold by GlaxoSmithKline PLC, and Actos, made by Takeda Pharmaceutical Co. Ltd., have a significantly increased risk of heart attack, congestive heart failure and death compared to the other diabetes treatments, according to an article published Tuesday in the Journal of the American Medical Association.These findings provide further evidence that this type of drug may cause more harm than good, the authors suggested.Both Avandia and Actos belong to a class of medications called thiazolidinediones, or TZDs, which were introduced in the late 1990s as an adjunctive treatment for type-2 diabetes.Earlier this year, they attracted scrutiny from health regulators and caused concerns among physicians and patients after some researchers indicated that both drugs may increase the risk of heart failure.Avandia, which last year was GlaxoSmithKline's second-best-selling product with sales of $3.3 billion, has also been linked with an increased risk of heart attack and death. The product has been allowed to remain on the market with strong warnings from regulators in Europe and the U.S., but its sales have plummeted. Researchers at the Institute for Clinical Evaluative Sciences in Toronto studied the risk of heart failure, heart attack and death among diabetic patients aged 66 or older.They analyzed data from healthcare databases in Ontario that included 159,026 diabetics who were followed for around 3.8 years until March 2006.Compared with patients taking other diabetes treatments, people treated with TZDs had a 60% increased risk of congestive heart failure, a 40% increased risk of heart attack and a 29% increased risk of death, the researchers found. These increased risks appeared limited to Avandia, because there were twice as many patients taking the drug compared with Actos, lead researcher Lorraine Lipscombe said."These findings provide evidence from a real-world setting and support data from clinical trials that the harms of TZDs may outweigh their benefits, even in patients without obvious baseline cardiovascular disease," the researchers wrote.

They concluded that further studies are needed to evaluate whether the risks linked to these drugs are specific to Avandia.