According to a systematic review of data by German researchers,little evidence supports using rosiglitazone (Avandia) to improve the quality or length of life among adults with diabetes .
Furthermore, data suggest that the drug might worsen complications of the disease such as weight gain, swelling, bone fractures and heart disease. The new review supports findings from an analysis of studies, published in May, which reported an increased risk of death from cardiovascular causes in patients taking the medication.
On May 21, the Food and Drug Administration issued a safety alert saying, Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information.
The benefit-risk ratio of rosiglitazone therapy in type 2 diabetes mellitus needs urgent clarification, say the authors of the latest review, led by Bernd Richter, M.D., of Heinrich-Heine University.
New safety data should lead to a very cautious approach to rosiglitazone use. If possible, other antidiabetic medications should be employed.
The findings are particularly alarming because heart disease accounts for nearly 70 percent of deaths among people with diabetes. Type 2 diabetes affects about 18 million to 20 million Americans, according to the American Diabetes Association.
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research.
Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The authors pooled data from 18 randomized controlled trials including more than 8,000 participants. About half of the patients took rosiglitazone and the others received eithe
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