title: Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.
abstract: BACKGROUND
  Women have lower rates of quitting than men with both bupropion and nicotine replacement. It is unknown whether varenicline demonstrates differential efficacy for men and women. The purpose of this study was to conduct the first comprehensive meta-analysis of clinical trial data examining sex differences in the efficacy of varenicline for smoking cessation.
  
  
  METHODS
  Searching MEDLINE, EMBASE, and PsychINFO, 17 of 43 clinical trials of varenicline for smoking cessation published through December 31, 2014 were low-bias randomized double-blind placebo-controlled trials. Data (n = 6710 smokers, 34% female, n = 16 studies, 96% of available data) was analyzed with Metafor program in R. Outcome endpoints were 7-day point-prevalence (PP) and continuous-abstinence (CA) at week 12 (end of treatment), week 24 (6-month follow-up), and week 52 (12-month follow-up).
  
  
  RESULTS
  Using placebo, women were less likely than men to quit (PP-12, CA-24; P < .05 for sex). Using varenicline, similar rates of abstinence for men and women were demonstrated for all six outcomes (eg, PP-12 abstinence rates were 53% in both women and men). Varenicline versus placebo outcomes demonstrated that varenicline was more effective for women for short and intermediate outcomes (PP-12, CA-12, CA-24; P < .05 sex × medication interaction). For end-of-treatment PP, varenicline was 46% more effective for women. For continuous abstinence, varenicline was 34% (CA-12) and 31% (CA-24) more effective for women.
  
  
  CONCLUSIONS
  Unlike other smoking cessation medications, varenicline demonstrated greater efficacy among women smokers for short and immediate-term outcomes and equal efficacy for 1-year outcomes. Varenicline may be particularly useful for reducing the sex disparity typically seen in rates of smoking cessation.
  
  
  CONCLUSIONS
  Varenicline is currently the most effective FDA-approved smoking cessation medication and this is the first demonstration that women compared with men have a preferred therapeutic response for a smoking cessation medication when considering short-term outcomes. Importantly, this is also the first demonstration that women have similar rates of quitting to men when considering longer-term, 1-year outcomes.
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT; Women's Health Research at Yale, Yale University School of Medicine, New Haven, CT; Cancer Prevention and Control Research Program, Yale Cancer Center, New Haven, CT; sherry.mckee@yale.edu.
authors.forename: Sherry A
authors.initials: SA
authors.lastname: McKee
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT;
authors.forename: Philip H
authors.initials: PH
authors.lastname: Smith
authors.affiliation: Department of Cognitive, Linguistic, and Psychological Sciences, Brown University, Providence, RI;
authors.forename: Mira
authors.initials: M
authors.lastname: Kaufman
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT; Women's Health Research at Yale, Yale University School of Medicine, New Haven, CT;
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Mazure
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT; Women's Health Research at Yale, Yale University School of Medicine, New Haven, CT; Cancer Prevention and Control Research Program, Yale Cancer Center, New Haven, CT; Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY.
authors.forename: Andrea H
authors.initials: AH
authors.lastname: Weinberger
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D000068580:Varenicline / Q000627:therapeutic use*
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline