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Wednesday, May 23, 2007A widely prescribed drug to treat Type 2 diabetes substantially increases the risk of heart attacks and death from cardiovascular disease, according to a study released Monday that critics say questions the government's ability to monitor drug safety. Patients who took Avandia to reduce their blood sugar levels were 43 percent more likely to have a heart attack than patients who were given other medications or a placebo. Researchers also found the drug boosted the chances of dying of heart disease by 64 percent, according to the report in the New England Journal of Medicine. The actual numbers of patients taking the drug who had heart attacks, however, are not so impressive. A difference of 1-2 events between people taking the drug and those not taking it hardly warrants a significant difference. And despite the trumpeting of their results, the authors acknowledge the limitations of their analysis: Our study has important limitations. We pooled the results of a group of trials that were not originally intended to explore cardiovascular outcomes. Most trials did not centrally adjudicate cardiovascular outcomes, and the definitions of myocardial infarction were not available. Many of these trials were small and short-term, resulting in few adverse cardiovascular events or deaths. Accordingly, the confidence intervals for the odds ratios for myocardial infarction and death from cardiovascular causes are wide, resulting in considerable uncertainty about the magnitude of the observed hazard. Furthermore, we did not have access to original source data for any of these trials. Thus, we based the analysis on available data from publicly disclosed summaries of events. The lack of availability of source data did not allow the use of more statistically powerful time-to-event analysis. A meta-analysis is always considered less convincing than a large prospective trial designed to assess the outcome of interest. Although such a dedicated trial has not been completed for rosiglitazone, the ongoing Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial may provide useful insights. Perhaps it would be best to wait for the results of the RECORD trial before accusing the FDA of malfeasance in this case. Also, these findings aren't as new as they're being spun. Avandia has been known to increase the risk of heart failure for a couple of years. Which is one reason why this doctor avoids it. posted by Sydney on 5/23/2007 08:38:00 AM 2 comments 2 Comments:
Remember Pargluva....
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and what about pioglitazone?
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