Glaxo-Funded Avandia Study Adds to ControversyJun 8, 2009 | Parker Waichman LLP
A newly published Avandia study has found that the controversial diabetes drug "significantly" raises the risk of heart failure and fractures. But unlike previous research, this study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. However, according to a report on WebMD, the study - known as RECORD- is causing some controversy because it was funded by GlaxoSmithKline, the maker of Avandia.
Avandia’s cardiovascular side effects have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.
Concerns over Avandia's safety had prompted the American Diabetes Association to advise against prescribing Avandia in favor of Actos, another drug in the same class, WebMD said. But now, the Association may reconsider that stance in light of the RECORD study.
According to an article on usnews.com, the Website of U.S. News and World Report, the RECORD study involved 4,447 patients with type 2 diabetes, randomly selected to take Avandia plus metformin and sulfonylurea or just metformin and sulfonylurea. The study was not blinded, meaning that study investigators and patients knew which treatment they were getting, WebMD said.
At a news conference announcing the RECORD results, Dr. Philip D. Home, chairman of the study steering committee and a professor of diabetes medicine at Newcastle University in Britain said Avandia "clearly has a role, alongside other drugs [in the treatment of diabetes], provided you obey the contraindications, which are not to use it in people with heart failure and to think twice for people at high risk for fractures."
But not everyone is so sure. Dr. Stephen Nissen, who conducted the 2007 study that first found an increase risk of heart attacks among Avandia users, is among them. According to usnews.com, Nissen called the RECORD study "seriously flawed" because more patients in the Avandia group were taking cholesterol-lowering statins and that group had what looked to be a high drop-out rate. "Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it," Nissen said.
In the same report, Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York City, said that determining which patients might safely use Avandia might prove difficult, as type2 diabetes already puts people at a higher risk of heart disease.