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Sunday, April 28, 2002"A review of clinical trials originally conducted by SmithKline Beecham Pharmaceuticals--the maker of Avandia--was undertaken by Dr. Harold E. Lebovitz of State University of New York in Brooklyn. Lebovitz, who is a major stock shareholder in SmithKline Beecham, also sits on the company's advisory board. For the review, Lebovitz and his team re-examined the data from 13 studies that originally aimed to examine the efficacy and safety of Avandia. "No evidence of (liver toxic) effects was observed in studies that involved 5,006 patients taking rosiglitazone," Lebovitz and colleagues write.” (Admitttedly, he might be a little biased.) Yet, the New York Times says Avandia and a related drug, Actos, are risky: “GlaxoSmithKline and Eli Lilly & Company have added warnings about heart and liver risks to the labels of their diabetes drugs, which are similar to a medication that was withdrawn from the market in 2000 because of links to fatal liver damage. The Food and Drug Administration posted information today about heart and liver risks in Glaxo's drug, Avandia, and in Actos from Lilly, although warnings were added to the labels earlier.” Actually, the New York Times story is wrong. The FDA did issue a warning about both Actos and Avandia, but it wasn’t about liver damage, it was about the risk of congestive heart failure. Even then, the FDA is being very conservative in issuing the warning. They based the decision on studies that compared people who take insulin alone to people who take both insulin and one of the drugs. The studies involved small numbers of patients, making it difficult to generalize the results. Only four of 566 patients in the Actos study developed heart failure. No numbers are given for the Avandia study. It’s not clear that these are clinically significant differences, especially when you consider that people with diabetes are already at risk for heart failure. That risk is higher for those whose diabetes is poorly controlled. Since both Avandia and Actos work by increasing the body’s sensitivity to insulin, they are used in patients who are not responding well to insulin alone. It could just be that the patients on both insulin and the drugs were in poorer health to begin with and had a higher risk of heart problems than those on insulin alone. posted by Sydney on 4/28/2002 05:37:00 AM 0 comments 0 Comments: |
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