Monday, July 4, 2011

FDA Places Smokers Between Proverbial Rock and Hard Place Part 2

Just over 2 weeks ago, I wrote about a new FDA announcement warning about an increase risk for heart disease and peripheral vascular disease in those patients w/cardiovascular disease who used varenicline (Chantix) to stop smoking.  Well, in a meta-analysis just released today by our neighbors to the North, the authors noted a small but significant increase in absolute risk for serious cardiovascular events in those users of varenicline (1.06%) who had no baseline history of cardiovascular disease compared to those randomized to placebo (0.82%).  

Are the numbers strong?  How about 14 randomized, placebo-controlled trials including 8,216 individuals over 7 to 52 weeks.  Less than 2 months of varenicline and risk of an ischemic or arrhythmic adverse cardiovascular event is increased in someone who previously had no history of cardiovascular events.

Is varenicline worth it?  In a commentary, one of the authors stated that this would not change his prescribing habits.  But it should also be noted that this author disclosed a relationship to Pfizer, the manufacturer of varenicline. Hmmmm . . . Seems to me there are safer options to help quit smoking, eg nicotine, bupropion, and even texting!  Or better yet, don't start!

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