Coming on the heels of revelations that Pfizer dragged its feet in reporting suicides associated with its stop-smoking drug, Chantix, is an FDA advisory linking the drug with an increase in heart attacks in patients with stable cardiovascular disease.
The rate of heart attacks for patients taking Chantix was more than double that for those given a placebo. In fairness, I should point out that the absolute increase in heart attacks was small – on the order of one percent – but the benefits of Chantix also are small. The studies which formed the basis for FDA approval of Chantix found that subject who received varenicline (the active ingredient in Chantix) for twelve weeks had a one-year successful quit rate on the order of 22%. That doesn’t sound too bad, but the rate for subjects who got the placebo was about 14%. In plain English, approximately 8% of the experimental subjects, or one out of twelve, did better with varenicline that they would have with a placebo. And this was after the designers of the study did everything they could to maximize the quit rate, by rejecting one-third of prospective study subjects because of any of a vast variety of medical conditions, as well as providing study subjects with stop-smoking support beyond the wildest dreams of the average quitter.
Common sense would seem to indicate that in the real world, in the absence of such support, the quit rate would be much smaller. Can anyone think of a reason why there should be a concomitant decrease in the rate of heart attacks?
Photo via Wikimedia Commons
UPDATE: A meta-analysis published in the Canadian Medical Association Journal found that in smokers without a history of cardiovascular disease, varenicline was associated with a 72% increase in the relative risk of serious cardiovascular events (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death) as compared to a placebo. I repeat, why is this stuff allowed to remain on the market?
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Richard Rider
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Lucinda Bliss
LEV JANASHVILI
TimingLogic
Patrick Frank
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