A popular prescription drug for type 2, or adult-onset, diabetes increases a person’s risk of heart attack, an analysis of 42 clinical trials suggests.
The drug, called rosiglitazone or Avandia, is taken to lower blood sugar. The Food and Drug Administration approved the drug in 1999, and more than 11 million prescriptions were filled for it last year in the United States.
In the new analysis, researchers tabulated heart attacks among 15,560 people with diabetes who got rosiglitazone in various trials and 12,283 people who also had diabetes but didn’t receive the drug.
There were 86 heart attacks in the rosiglitazone group and 72 in the control group. After statistical adjustment, that yields a 43 percent higher risk of heart attack among rosiglitazone users, says study coauthor Steven E. Nissen, a cardiologist at the Cleveland Clinic. He and his colleague Kathy Wolski report their findings online in the June 14 New England Journal of Medicine.
Philadelphia-based GlaxoSmithKline makes rosiglitazone. The company’s chief medical officer, Ronald L. Krall, responded online and in the June 16 Lancet that the data show only rare heart attacks in the large patient populations analyzed. He argues that a close analysis of past and ongoing trials of rosiglitazone will acquit the drug.
The FDA has assigned a panel to reconsider the drug’s approval.