title: Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Prevalence rates of smoking are rising in developing countries. Previous trials evaluating the efficacy and tolerability of the smoking-cessation medication varenicline have used largely participants of Caucasian origin.
  
  
  OBJECTIVE
  This study was conducted to evaluate the efficacy and tolerability of varenicline in populations of participants from Latin America, Africa, and the Middle East to investigate potential differences in the therapeutic response to varenicline.
  
  
  METHODS
  This multinational, randomized, double-blind, placebo-controlled trial was conducted at 42 centers in 11 countries (Latin America: Brazil, Colombia, Costa Rica, Mexico, and Venezuela; Africa: Egypt and South Africa; Middle East: Jordan, Lebanon, Saudi Arabia, and the United Arab Emirates). Participants were male and female smokers aged 18 to 75 years who were motivated to stop smoking; smoked ≥10 cigarettes/d, with no cumulative period of abstinence >3 months in the previous year; and who had no serious or unstable disease within the previous 6 months. Subjects were randomized in a 2:1 ratio to receive varenicline 1 mg or placebo, BID for 12 weeks, with a 12-week nontreatment follow-up. Brief smoking-cessation counseling was provided. The main outcome measures were carbon monoxide-confirmed continuous abstinence rate (CAR) at weeks 9 to 12 and weeks 9 to 24. Adverse events (AEs) were recorded for tolerability assessment.
  
  
  RESULTS
  Overall, 588 subjects (varenicline, 390; placebo, 198) were randomized and treated. The mean (SD) ages of subjects in the varenicline and placebo groups were 43.1 (10.8) and 43.9 (10.8) years, respectively; 57.7% and 65.7% were male; and the mean (SD) weights were 75.0 (16.0) and 76.7 (16.3) kg (range, 40.0-130.0 and 45.6-126.0 kg). CAR at weeks 9 to 12 was significantly higher with varenicline than with placebo (53.59% vs 18.69%; odds ratio [OR] = 5.76; 95% CI, 3.74-8.88; P < 0.0001), and this rate was maintained during weeks 9 to 24 (39.74% vs 13.13%; OR = 4.78; 95% CI, 2.97-7.68; P < 0.0001). Nausea, headache, and insomnia were the most commonly reported AEs with varenicline and were reported numerically more frequently in the varenicline group compared with the placebo group. Serious AEs (SAEs) were reported in 2.8% of varenicline recipients compared with 1.0% in the placebo group, with 6 subjects reporting psychiatric SAEs compared with none in the placebo group.
  
  
  CONCLUSIONS
  Based on these data, varenicline was apparently efficacious and generally well tolerated as a smoking-cessation aid in smokers from selected sites in Latin America, Africa, and the Middle East. ClinicalTrials.gov identifier: NCT00594204.
authors.affiliation: Respiratory Research Unit, Faculty of Health Sciences, University of Stellenbosch, Cape Town, South Africa. ctb@sun.ac.za
authors.forename: Chris T
authors.initials: CT
authors.lastname: Bolliger
authors.forename: Jaqueline S
authors.initials: JS
authors.lastname: Issa
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Posadas-Valay
authors.forename: Tarek
authors.initials: T
authors.lastname: Safwat
authors.forename: Paula
authors.initials: P
authors.lastname: Abreu
authors.forename: Eurico A
authors.initials: EA
authors.lastname: Correia
authors.forename: Peter W
authors.initials: PW
authors.lastname: Park
authors.forename: Pravin
authors.initials: P
authors.lastname: Chopra
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D000368:Aged; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D008877:Middle East; D018722:Nicotinic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D012907:Smoking / Q000453:epidemiology; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D000068580:Varenicline; D055815:Young Adult
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline