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Comparative Safety of Smoking Cessation Pharmacotherapies During a Government-Sponsored Reimbursement Program.

INTRODUCTION
The British Columbia Ministry of Health launched a Smoking Cessation Program on September 30th 2011, providing financial coverage for smoking cessation pharmacotherapies. Although pharmacotherapies have been shown to have a moderate short-term benefit as a quitting aid, substantial cardiovascular and neuropsychiatric safety concerns have been identified in adverse reporting databases, leading to prescription label warnings by Health Canada and the U.S. FDA. However, recent studies indicate these warnings may be without merit. This study examined the comparative safety of medications commonly used to aid smoking cessation.


METHODS
Population-based retrospective cohort study using B.C. administrative data to assess the relative safety between varenicline, bupropion, and nicotine replacement therapies (NRTs). The primary outcome was a composite of cardiovascular hospitalizations. Secondary outcomes included: mortality, a composite of neuropsychiatric hospitalizations, and individual components of the primary outcome. Statistical analysis used propensity score adjusted log-binomial regression models. A sensitivity analysis excluded patients with a history of cardiovascular disease.


RESULTS
116,442 participants were included. Compared to NRT, varenicline was associated with a 10% one-year relative risk decrease of cardiovascular hospitalization [Adjusted Risk Ratio (RR) = 0.90, 95% Confidence Interval (CI): (0.82-1.00)], a 20% one-year relative risk decrease of neuropsychiatric hospitalization [RR: 0.80, CI: (0.7 -0.89)], and a 19% one-year relative risk decrease of mortality [RR: 0.81, CI: (0.71-0.93)]. We found no significant association between NRT and bupropion for cardiovascular hospitalizations, neuropsychiatric hospitalizations, or mortality.


CONCLUSIONS
Compared to NRT, varenicline is associated with less and bupropion the same number of serious adverse events.