WHAT’S NEW: Evidence of CV risk is cause for concern
This meta-analysis provides evidence that varenicline is associated with a small but significant harmful effect on CV outcomes. The methods Singh et al used for review and article selection appear to be sound, and analysis of the included studies reveals little likelihood of publication bias.
CAVEATS: For many, benefits of quitting outweigh the risks
The absolute risk of a CV event found in this meta-analysis was small—just 0.24%. What’s more, the primary outcome was a composite of a diverse group of outcomes, some more serious than others. And, when compared with the highly positive effects of smoking cessation, the benefit-harm analysis still appears to favor varenicline for most patients. The estimated number needed to treat to get one person to stop smoking for ≥24 weeks is about 10 (95% CI, 8-13).8
CHALLENGES TO IMPLEMENTATION: Finding time to educate patients
The additional time needed to discuss the CV and neuropsychiatric risks of varenicline will be a challenge to physicians working in busy outpatient settings. Proper documentation of this discussion is prudent, however, given the increase in risk with this medication.
Acknowledgement
The Purls Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.