Varenicline go ahead in heart patients

Medicine 110 Comments

In June 2011, the US FDA said that varenicline may increase the risk of adverse cardiovascular events in patients with known cardiovascular disease [1].

This was based on a randomized trial that found a non-statistically significant increase in cardiovascular events in 714 smokers with stable CVD treated with varenicline [2].

Though the rate of cardiovascular mortality was lower and smoking cessation rates were higher in the varenicline group.

A subsequent meta-analysis of 14 randomized placebo-controlled trials of varenicline in 8216 smokers with no or stable CVD found a statistically significant increase in the risk of myocardial ischemia, arrhythmia, heart failure, sudden death, or cardiovascular-related death for the varenicline group [3]. Twenty-eight patients with stable CVD would need to be treated with varenicline for one year to cause one additional serious cardiovascular event while 10 patients would need to be treated for one additional patient to quit smoking.

Over long term benefits of smoking cessation will likely outweigh potential short-term harms of varenicline in CVD patients


  1. (Accessed on June 16, 2011).
  2. Rigotti NA, Pipe AL, Benowitz NL, et al. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation 2010;121:221.
  3. Singh S, Loke YK, Spangler JG, Furberg CD. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. CMAJ 2011;183:1359.