May 4th, 2012

Reanalyzed Chantix Data Yield Smaller CV Risk, New Controversy

A new meta-analysis criticizes earlier work warning that the smoking-cessation drug varenicline (Chantix) poses increased cardiovascular risks.

The analysis appears in BMJ. It was performed by researchers with no current ties to the drug maker, but one of whom had received a Pfizer investigator-initiated research award.

The new analysis examined the risk of treatment-emergent serious cardiovascular events during 22 randomized placebo-controlled trials comprising over 9200 participants. Events were those defined as occurring within 30 days of stopping treatment (the earlier analysis included events up to 1 year later). Contrary to the earlier findings, the new analysis found a cardiovascular event rate of 0.63% with varenicline and 0.47% with placebo.

Calling the risk estimate of the earlier analysis “inflated,” the authors say that, on the contrary, the risk associated with varenicline use “is statistically and clinically insignificant.” Sonal Singh, author of the earlier meta-analysis, says he stands by his results and that “people need to look at the data and make up their own minds.”

[Editor’s note: Although the paper has passed its embargo time, it is not yet available on BMJ‘s site. BMJ‘s press office has assured us that it will be there shortly. Here is a link to BMJ‘s “Just Published” page.]

This post is reprinted from Physician’s First Watch, a part of the Journal Watch family. PFW is a free daily alert on current news that affects your practice — from medical journals, government agencies, scientific conferences, and major media reports.

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