| Titre : |
The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers : a randomized controlled trial |
| Type de document : |
texte imprimé |
| Auteurs : |
Raymond S. Niaura, Auteur ; J. Taylor Hays, Auteur ; Douglas E. Jorenby, Auteur |
| Editeur : |
Abingdon [Angleterre] : Taylor & Francis Group |
| Année de publication : |
2008 |
| Collection : |
Current medical research and opinion, ISSN 0300-7995 num. Vol 24, n. 7 |
| Importance : |
p. 1931-1941 |
| Présentation : |
graph., tab. |
| Langues : |
Anglais (eng) |
| Catégories : |
[TABAC] étude
[TABAC] sevrage tabagique:méthode de sevrage:méthode individuelle:approche pharmacologique:varénicline
|
| Index. décimale : |
TA 6.2.3.1.4 Autres substituts nicotiniques |
| Résumé : |
Abstract
OBJECTIVE:
To determine whether self-regulated flexible dosing with varenicline tartrate is safe and effective for smoking cessation.
RESEARCH DESIGN AND METHODS:
320 healthy, motivated-to-quit smokers (> or =10 cigarettes/day) aged 18-65 years, entered a multicenter, randomized, double-blind, placebo-controlled study - conducted between December 26, 2001 and June 24, 2003 - with a 12-week treatment phase and 40-week, double-blind, non-treatment follow-up. Treatment consisted of varenicline or placebo in fixed doses (Week 1: titrated from 0.5 to 1.0 mg/day) followed by a self-regulated flexible schedule (Weeks 2-12: 0.5-2.0 mg/day).
MAIN OUTCOME MEASURES:
Primary outcomes included carbon monoxide-confirmed continuous abstinence rate (CAR) from smoking for Weeks 4 through 7, 9 through 12, and 9 through 52. Secondary outcomes included CAR from Weeks 9 through 24, 7-day point prevalence of abstinence, safety assessments, and measures of craving, withdrawal, and smoking reward.
RESULTS:
Superior CARs were observed in varenicline-treated (n = 157) versus placebo participants (n=155) for Weeks 4 through 7 (38.2 vs. 11.6%), 9 through 12 (40.1 vs. 11.6%), 9 through 24 (28.0 vs. 9.0%), and 9 through 52 (22.3 vs. 7.7%) (all p<0.001). Seven-day point prevalence was higher in varenicline-treated than placebo participants at Weeks 12 (46.5 vs. 14.2%; p<0.001), 24 (32.5 vs. 13.5%; p<0.001), and 52 (28.0 vs. 13.5%; p=0.001). Overall, medication compliance was high, although varenicline-treated, but not placebo, participants tended to taper down their dosage over time. Total treatment-emergent AEs were 77.1% (varenicline: 121/157) and 65.8% (placebo: 102/155). Few AEs led to treatment discontinuation (varenicline: 11/157, 7.0% and placebo: 7/155, 4.5%). Participants were primarily healthy Caucasians, so more research is necessary to determine how applicable these findings are to other populations.
CONCLUSIONS:
A self-regulated, flexible dosing regimen of varenicline is well tolerated, with superior effectiveness versus placebo for smoking cessation. |
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