Prescribing Advice for GPs

Rosiglitazone increases CV events

May 22, 2007 at 1:20 pm | In Prescribing Extra - Drugs | Print | 4 Comments

The New England Journal of Medicine has published the results of a meta-analysis examining the cardiovascular safety of rosiglitazone as an online first article. There is currently free access to full text and PDF versions of the paper.

The study included analysis of 42 papers including data for almost 28,000 patients. Data were collected for outcomes of myocardial infarction and death from cardiovascular causes.

Due to limitations in the published data it was not possible to calculate hazard ratios, however there was a statistically increased risk of myocardial infarction (Odds ratio 1.43, 95% confidence interval [CI], 1.03 to 1.98; P=0.03) and a non significant increase in the risk of cardiovascular death (Odds ratio 1.64, 95% CI, 0.98 to 2.74; P=0.06).

Despite the limitations imposed by a lack of access to original source data the authors of this analysis conclude that clinicians "should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone".

Pioglitazone was not studied in this analysis. The PROactive study did contain a secondary endpoint showing some cardiovascular benefit. However, since the primary endpoint in that study did not reach statistical significance the validity of this benefit has been questioned.

Action: Metformin remains the first line hypoglycaemic in all patients with type 2 diabetes. Once the symptoms of diabetes are relieved treatment should focus upon lowering blood pressure and cardiovascular risk, not on lowering blood glucose. Pioglitazone or a sulphonylurea may be suitable choices if additional hypoglycaemic agents are deemed necessary.