Smoking cessation medication varenicline does not appear to be associated with an increased risk of cardiovascular or neuropsychiatric hospitalization compared with nicotine replacement therapy.
The smoking cessation medication varenicline (Chantix, Pfizer) does not appear to be associated with an increased risk of cardiovascular (CV) or neuropsychiatric hospitalization compared with nicotine replacement therapy (NRT), according to a study published in Addiction.
Researchers also found that bupropion (Wellbutrin) is associated with a lower cardiovascular hospitalization and a higher risk of neuropsychiatric hospitalization compared with NRT.
The real world study included 618,497 participants with no previous diagnosis or treatment for depression in the prior 12 months. Researchers used propensity score adjusted log-binomial regression models. The primary outcome was a composite of hospitalized CV events, whereas secondary outcomes included a composite of hospitalized neuropsychiatric events and individual components of the primary outcome.
Compared with NRT, varenicline and bupropion were associated with a 20% and 25% lower 1-year risk of CV hospitalization, respectively. Additionally, varenicline and bupropion were associated with a 35% lower and 21% higher 1-year risk of neuropsychiatric hospitalization, respectively.
Varenicline is among the most effective smoking cessation medications currently available. A 2013 Cochrane Review found that it was more effective for smoking cessation than bupropion and single-form NRT, although evidence on the efficacy of long-term smoking abstinence is limited.
In 2009, the FDA imposed a black box warning for psychiatric adverse effects and included additional warnings in prescribing information concerning CV events in 2012 and serious neuropsychiatric symptoms and suicidality in 2013. The black box warning was removed in 2016, according to the press release.
“While we support the FDA’s efforts to monitor the safety or its approved products, the warnings for varenicline and bupropion have become increasingly inconsistent with evidence from subsequent clinical trials and observational research. We hope that our study’s findings will promote a better understanding of these medications for quitting smoking,” said Greg Carney, MD, lead author in the press release.