Rosiglitazone on Trial31 May 2007

The risk of cardiovascular events with rosiglitazone.

The business pages of the newspapers were full of the news that 10% had been lopped off the share price of GlaxoSmithKline following a report in the New England Journal of Medicine on the risk of cardiovascular events with rosiglitazone.

The report was a so-called "meta-analysis" of other research projects. Meta-aanalysis combines the results of many trials to see if meaningful results can be obtained from the larger numbers of patients involved.

Trials in diabetes which look at complications normally have to be large and run for many years to achieve valid results - DCCT ran for 13 years and UKPDS for 20 years. The majority of the trials in the recently published report were of short duration. Although the total number of patients was impressive - nearly 28,000 - the actual number of events recorded was small - 158 myocardial infarctions and 94 cardiovascular deaths. Bearing in mind that some patients may appear in these figures twice (if the myocardial infarction caused the cardiovascular death), fewer than 0.1% of patients suffered a myocardial event despite the mean age of the patients being 56.

Nevertheless, the group treated with rosiglitazone suffered more events although it would have required a very small shift in numbers to give a different result.

So what should we do?

I think that "wait and see" is what most experts will do. The results of the first large long-term outcome trials on whether glitazones reduce cardio-vascular disease in diabetes are expected towards the end of 2008. This is the testing time.

If any therapy whether biguanide, sulphonylurea or glitazone prescribed in diabetes does not reduce the risk of complications then its use can be called into question.

If the report had not appeared in so prestigious a journal as the New England Journal of Medicine, it would probably not have caused to many waves.

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Reference: Nissen, S & Wolski, K, 2007, Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes, NEJM; 356, 1-15