Safety of a Course of Varenicline Tartrate and Counseling Over Counseling Alone for Smoking Cessation: A 52-Week Randomized Controlled Trial for Inpatients (STOP Study)

Introduction : Inpatient medical settings offer an opportunistic environment to initiative smoking cessation interventions to patients reflecting on their health. Current evidence suggests superior efficacy of varenicline tartrate (VT) for smoking cessation over that of other tobacco cessation therapies, however, recent evidence has highlighted concerns around safety and tolerability. Given these apprehensions, we aimed to evaluate the safety and effectiveness of VT plus Quitline-counseling compared to Quitline-counseling alone in the inpatient medical setting. Methods: Adult patients (n = 392, 20–75 years) admitted with a smoking-related illnesses to 3 hospitals, were randomized to receive either 12-weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice daily) plus Quitline-counseling (VT+C), (n = 196) or Quitline-counseling alone, (n = 196). Results: VT was well tolerated in the inpatient setting in subjects admitted with acute smoking-related illnesses (mean age 52.8±2.89 and 53.7±2.77 years in the VT+C and counseling alone groups, respectively). The most common self-reported adverse event during the 12-week treatment phase was nausea with 16.3% in the VT+C group compared with 1.5% in the counseling alone group. Thirteen deaths occurred during the study period, n = 6 were in the VT+C arm compared with n = 7 in the counseling alone arm. All of these subjects had known or developed underlying comorbidities. Conclusions: VT appears to be a safe and well tolerated opportunistic treatment for inpatient smokers with related chronic disease. Based on the proven efficacy of varenicline from outpatient studies and our recent inpatient evidence, we suggest it be considered as part of standard care in the hospital setting.

Nicotine & Tobacco Research

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