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Vareniciline, bupropion may not increase risk of cardiovascular events
Clinical Question
Do smoking cessation aids increase the risk of cardiovascular events?
Bottom line
Over one year, major cardiovascular events were not more likely in smokers treated with varenicline (Chantix) or bupropion as compared with those treated with placebo. However, these were young patients (younger than 50 years) and most had few cardiovascular risk factors other than smoking. At least 2 previous studies showed an increased cardiovascular risk with the use of varenicline, so this short and underpowered study is not completely reassuring. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (any)
Synopsis
This study is a double-blind study conducted at 140 sites across the world to evaluate the effect of varenicline, bupropion, or nicotine replacement therapy on cardiovascular outcomes. The study specifically enrolled patients with psychiatric diagnoses; an earlier report (http://dx.doi.org/10.1016/S0140-6736(16)30272-0) evaluated the effect of treatment on neuropsychiatric adverse events. The 8058 patients in this study were an average 47 years old. Though most (69%) were at low cardiovascular risk, patients at high cardiovascular risk—greater than 20% over 10 years—were also enrolled (8.5% of the total). Initially, patients were randomly assigned (using allocation concealment) to one of the smoking cessation treatments or placebo for 12 weeks, followed by 36 weeks of follow-up. This follow-up comprised only patients who took at least one dose of treatment; the average duration of this follow-up was 10.5 weeks. The likelihood of major adverse cardiovascular events—cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke—was, not surprisingly, low in this young cohort (less than 0.5%) and was not increased with treatment as compared with placebo. However, this study is likely too small and too short to provide any real reassurance. A previous meta-analysis (POEM 131203) and a recent observational study (doi: 10.1164/rccm.201706-1204OC) have linked varenicline use to an increase in cardiovascular events.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Comments
D’un côté rassurant que chez des patients plus jeunes les traitements n’ont pas causé plus d’évènements cardiovasculaires mais il reste à voir chez nos patients plus vieux si cela restera vrai
This indicates that it is most imperative that smokers be helped to quit before they reach the age where risks, if they exist, may start having an impact on their health. That may prevent at least, some of the consequences of several decades of smoking.
I agree that the study should be repeated and powered better.
good poem
IMHO the risk of CV and lung disease due to smoking outweighs any small risks of these drugs .... Period