Rosiglitazone Increases Risk of Heart Failure, Death Compared With Pioglitazone
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Rosiglitazone Increases Risk of Heart Failure, Death Compared With Pioglitazone

LONDON -- August 20, 2009 -- Rosiglitazone is associated with an increased risk of heart failure and death among older patients compared with pioglitazone, according to a study published on bmj.com.

As such, the researchers say it is difficult to advocate continued use of rosiglitazone for most patients.

It is unclear whether there are clinically important differences in the cardiac safety of these 2 drugs, therefore researchers in Canada compared the risk of myocardial infarction (MI), heart failure, and death in patients treated with rosiglitazone and pioglitazone.

Using prescription records, they identified nearly 40,000 patients aged 66 years and older who started treatment with either rosiglitazone or pioglitazone between April 2002 and March 2008.

Data on hospital admission for either a MI or heart failure during the 6-year study period were recorded and deaths were identified from a national database.

Detailed analysis showed that patients treated with pioglitazone had a significantly lower risk of heart failure and death compared with patients treated with rosiglitazone, but there was no significant difference in the risk of MI.

The researchers estimated that, for every 93 patients treated with rosiglitazone rather than pioglitazone, 1 additional cardiovascular event or death would be predicted to occur annually.

“Our findings suggest clinically important differences in the cardiovascular safety profiles of rosiglitazone and pioglitazone in clinical practice,” the authors wrote.

“Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, it is reasonable to question whether ongoing use of rosiglitazone is justified.”

This study reinforces the message that thiazolidinediones should be avoided in heart failure patients. However, the claim that pioglitazone is safer than rosiglitazone is not fully supported by the data, according to two experts in an accompanying editorial. Although it may be tempting to move away from prescribing thiazolidinedione altogether, they wrote, long term follow-up data for newer products are not yet available.

Given that randomised trials are unlikely ever to provide the full picture, they suggest that enhancements to healthcare databases coupled with well designed studies like this one are essential for determining the full risk-benefit profile of medicines.

SOURCE: BMJ

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