Researchers Fault Recent Meta-Analysis on Rosiglitazone
Re-analysis of data shows no increased or decreased risk of heart attack or death
TUESDAY, Aug. 7 (HealthDay News) -- Diabetic patients who take rosiglitazone (Avandia) have neither an increased nor decreased risk of myocardial infarction and cardiovascular death, according to an article published online Aug. 7 in the Annals of Internal Medicine.
George A. Diamond, M.D., of the University of California Los Angeles, and colleagues reviewed a recent, widely publicized meta-analysis of 42 clinical trials involving 27,847 patients that found that rosiglitazone was associated with a 43 percent increased risk of myocardial infarction and a 64 percent increased risk of death from cardiovascular disease.
Diamond and colleagues fault the original study's authors for not assessing the sensitivity of their conclusions to several methodological choices and for not including all studies showing evidence of rosiglitazone's cardiovascular effects. Using alternate meta-analytic approaches, they found lower odds ratios for myocardial infarction and cardiovascular death that were not statistically significant.
"In the end, we believe that only prospective clinical trials designed for the specific purpose of establishing the cardiovascular benefit or risk of rosiglitazone will resolve the controversy about its safety," the authors conclude. "In our opinion, available evidence does not justify what the authors of the original meta-analysis (as well as the media, the U.S. Congress, and worried patient groups) decried as an 'urgent need for comprehensive evaluations.'"