A perioperative smoking cessation intervention with varenicline: a double-blind, randomized, placebo-controlled trial.
BACKGROUND
The efficacy of perioperative tobacco interventions on long-term abstinence and the safety of smoking cessation less than 4 weeks before surgery is unclear. Our objective was to determine the efficacy and safety of a perioperative smoking cessation intervention with varenicline to reduce smoking in elective surgical patients.


METHODS
In a prospective, multicenter, double-blind, placebo-controlled trial, 286 patients were randomized to receive varenicline or placebo. Both groups received in-hospital and telephone counseling during 12 months. The primary outcome was the 7-day point prevalence abstinence rate 12 months after surgery. Secondary outcomes included abstinence at 3 and 6 months after surgery. Multivariable logistic regression was used to identify independent variables related to abstinence.


RESULTS
The 7-day point prevalence abstinence at 12 months for varenicline versus placebo was 36.4% versus 25.2% (relative risk: 1.45; 95%: CI: 1.01-2.07; P = 0.04). At 3 and 6 months, the 7-day point prevalence abstinence was 43.7% versus 31.9% (relative risk: 1.37; 95% CI: 1.01 to 1.86; P = 0.04), and 35.8% versus 25.9% (relative risk: 1.43; 95%: CI 1.01-2.04; P = 0.04) for varenicline versus placebo, respectively. Treatment with varenicline (odds ratio: 1.76; 95% CI: 1.03-3.01; P = 0.04), and preoperative nicotine dependence (odds ratio: 0.82, 95% CI: 0.68 to 0.98; P = 0.03) predicted abstinence at 12 months. The adverse events profile in both groups was similar except for nausea, which occurred more frequently for varenicline versus placebo (13.3% vs. 3.7%, P = 0.004).


CONCLUSIONS
A perioperative smoking cessation intervention with varenicline increased abstinence from smoking 3, 6, and 12 months after elective noncardiac surgery with no increase in serious adverse events.
Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Jean
J
Wong
Amir
A
Abrishami
Yiliang
Y
Yang
Amna
A
Zaki
Zeev
Z
Friedman
Peter
P
Selby
Kenneth R
KR
Chapman
Frances
F
Chung
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D003367:Cotinine / Q000652:urine; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006293:Health Promotion; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D018401:Sample Size; D012907:Smoking / Q000188:drug therapy; D016540:Smoking Cessation / Q000379:methods*; D013689:Telephone; D014029:Tobacco Use Disorder / Q000188:drug therapy; D016896:Treatment Outcome; D000068580:Varenicline; D055815:Young Adult
D001552:Benzazepines; D011810:Quinoxalines; D003367:Cotinine; D000068580:Varenicline