Avandia heart risks seen at the population level

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Dr. Lorraine L. Lipscombe, from the Institute for Clinical Evaluative Sciences in Toronto, and colleagues analyzed data for 159,026 older adults who were treated with at least one oral diabetes drug between 2002 and 2005 and were entered in an Ontario healthcare database. The subjects were followed through March 2006.

NEW YORK (Reuters Health) - The findings of clinical trials have linked the use of thiazolidinediones, a class of diabetes drugs, with congestive heart failure and possibly heart attacks. Now, new research indicates that these associations, at least with Avandia, also apply to individuals in the community, and not just clinical trials.

Dr. Lorraine L. Lipscombe, from the Institute for Clinical Evaluative Sciences in Toronto, and colleagues analyzed data for 159,026 older adults who were treated with at least one oral diabetes drug between 2002 and 2005 and were entered in an Ontario healthcare database. The subjects were followed through March 2006.

During an average follow-up period of 3.8 years, 7.9 percent of the patients were hospitalized for congestive heart failure, 7.9 percent were hospitalized for a heart attack, and 19 percent died, according to the researchers' report in Journal of the American Medical Association.

Current thiazolidinediones use increased the risks of heart failure, heart attack and death by 60 percent, 40 percent, and 29 percent, respectively, compared with the use of other types of oral diabetes drugs.

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Further analysis revealed that the risks were largely confined to patients who were using Avandia, known generically as rosiglitazone.

"These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits, even in patients without obvious...cardiovascular disease," the authors write.

More studies are needed to better define the risk-benefit ratio and the trade-offs associated with thiazolidinedione therapy and to explore if the treatment risks are confined specifically to rosiglitazone.

SOURCE: Journal of the American Medical Association, December 12, 2007.