Effect of 0.5 mg versus 1 mg varenicline for smoking cessation: a randomized controlled trial.
Addiction
; 112(9): 1610-1619, 2017 Sep.
Article
in En
| MEDLINE
| ID: mdl-28449281
ABSTRACT
AIMS:
Varenicline is used in smoking cessation. The aims of the trial were to test for differences between standard 1- and 0.5-mg doses (both twice daily during 8 weeks) in (1) abstinence, (2) adherence and (3) side effects.DESIGN:
Open-label randomized parallel-group controlled trial with 1-year follow-up. All those randomized were included in the final sample using an intention-to-treat (ITT) approach.SETTING:
Stop-Smoking Clinic of the Virgen Macarena University Hospital in Seville, Spain.PARTICIPANTS:
The study comprised smokers (n = 484), 59.5% of whom were men with a mean age of 50.67 years and a smoking history of 37.5 pack-years. INTERVENTION AND COMPARATOR Participants were randomized to 1 mg (n = 245) versus 0.5 mg (n = 239) and received behavioural support, which consisted of a baseline visit and six follow-ups during 1 year. MEASUREMENTS The primary outcome was continuous self-reported abstinence during 1 year, with biochemical verification. The secondary outcomes were adherence and side effects. Also measured were baseline demographics, medical history and smoking characteristics.FINDINGS:
Abstinence rates at 1 year were 46.5% with 1 mg versus 46.4% with 0.5 mg [odds ratio (OR) = 0.997; 95% confidence interval (CI) = 0.7-1.43; P = 1.0]; Bayes factor in favour of H0 = 238.507, Bayes factor against H0 = 0.004. Treatment adherence was similar in both regimens (OR = 1.16; 95% CI = 0.8-1.7; P = 0.44). Side effects were reported in 19.3% of cases with 1 mg versus 12.1% with 0.5 mg, although with no significant differences between regimens (OR = 1.73; 95% CI = 0.94-3.18; P = 0.093).CONCLUSIONS:
There appears to be no difference in smoking cessation effectiveness between 1 mg and 0.5 mg varenicline, both administered twice daily for 8 weeks, with similar rates of abstinence (46.5% versus 46.4%), adherence and side effects.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tobacco Use Disorder
/
Smoking Cessation
/
Nicotinic Agonists
/
Varenicline
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Addiction
Journal subject:
TRANSTORNOS RELACIONADOS COM SUBSTANCIAS
Year:
2017
Document type:
Article
Affiliation country: