Meta-analysis confirms rosiglitazone's poor safety record

doi:10.1136/bmj.335.7620.586-b

BMJ 2007;335:586 (22 September), doi:10.1136/bmj.335.7620.586-b

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Meta-analysis confirms rosiglitazone's poor safety record

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Rosiglitazone is still approved by the US Food and Drugs Administration(FDA) for the treatment of type 2 diabetes, despite evidencefrom meta-analyses that it is associated with an increased riskof heart attack and heart failure

A third meta-analysis, this time confined to four trials lastingmore than a year, confirms these earlier findings. Patientstaking rosiglitazone were 42% more likely to have a heart attackthan controls taking other oral hypoglycaemic agents or placebo(94/6421 v 83/7870; relative risk, 1.42, 95% CI 1.06 to 1.91).They were also twice as likely to develop heart failure (2.09,1.52 to 2.88), a well known side effect of drugs in this class.Rosiglitazone was not associated with any excess deaths. Theauthors and a linked editorial (p 1216) agree that regulatoryagencies will need to look again at this agent. In the meantimedoctors should think carefully before prescribing it.