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Tuesday, June 29, 2010

Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems

ABC World News (6/28, story 7, 2:20, Sawyer) reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems."

        The CBS Evening News (6/28, story 10, 0:30, Smith) reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market."

        NBC Nightly News (6/28, story 8, 0:20, Williams) reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe."

        The Washington Post (6/29, Stein) reports that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death."

        The Los Angeles Times (6/29, Roan) reports that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine."

        USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death."

        The New York Times (6/29, Harris) reports that "the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." The Boston Globe (6/29, Rowland), Bloomberg News (6/29, Cortez), the AP (6/29, Tanner), the Wall Street Journal (6/29, Mundy, Dooren, subscription required), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner),MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story.

        Lawmakers Call For Avandia To Be Pulled From Market. The Hill (6/28, Pecquet) "Healthwatch" blog reported that "Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies." In a joint statement, Sen. Grassley said, "The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July."

        Bloomberg News (6/29, Peterson, Cortez) reports that "Grassley and Senator Max Baucus, a Montana Democrat, in February released a report that said Glaxo knew Avandia may cause heart damage several years before" a "study documented the risk."

        Rosiglitazone May Reduce Major Cardiovascular Event Risk In Patients With Type 2 Diabetes And Heart Disease.MedPage Today (6/28, Phend) reported that "rosiglitazone (Avandia) reduced major cardiovascular event risk in patients with co-existing type 2 diabetes and heart disease, according to a post-hoc analysis of the BARI 2D trial." This "trial -- sponsored by the National Institutes of Health, GlaxoSmithKline, maker of rosiglitazone, and other drug companies -- found a 29% reduced composite relative risk of death, MI, and stroke with the use of rosiglitazone versus no drug in the thiazolidinedione class (3.79 versus 5.81 per 100 patient-years, P=0.002)." These "findings reported at the American Diabetes Association meeting presented a dramatically different picture than that which emerged from a 56-trial meta-analysis in the Archives of Internal Medicine and a FDA analysis of Medicare patients in the Journal of the American Medical Association released earlier in the day."

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