Efficacy of Varenicline for Cigarette Reduction Before Quitting in Japanese Smokers: A Subpopulation Analysis of the Reduce to Quit Trial
| Autor: | Masakazu Nakamura, Peter W. Park, Ching-Ray Yu, Masaaki Abe, Joan Treadow, Masayuki Ohkura |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty media_common.quotation_subject medicine.medical_treatment 030204 cardiovascular system & hematology Placebo 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Asian People Double-Blind Method Internal medicine medicine Odds Ratio Humans Pharmacology (medical) 030212 general & internal medicine Nicotinic Agonists Adverse effect Varenicline Smoking Reduction media_common Pharmacology business.industry Odds ratio Tobacco Use Disorder Abstinence Middle Aged Treatment Outcome chemistry Tolerability Anesthesia Smoking cessation Female Smoking Cessation business |
| Zdroj: | Clinical Therapeutics. |
| ISSN: | 0149-2918 |
| DOI: | 10.1016/j.clinthera.2017.03.007 |
| Popis: | Purpose This prospective analysis of the Japanese subpopulation of the varenicline reduce to quit study was conducted to evaluate whether results for Japanese participants were consistent with the full study population. Methods Patients received varenicline or placebo for a 24-week treatment period (12-week smoking reduction phase then a 12-week smoking abstinence phase) followed by a 28-week nontreatment, follow-up phase. Participants were to reduce the daily number of cigarettes smoked by at least 50% by week 4 and by a further 50% by week 8, with the goal of achieving complete abstinence by week 12. The primary efficacy end point was the carbon monoxide–confirmed continuous abstinence during weeks 15 to 24. Findings Overall, 210 Japanese patients were randomly assigned to 1 of the 2 study groups (varenicline, 107; placebo, 103). Continuous abstinence rates for weeks 15 to 24 were higher for participants in the varenicline group versus the placebo group (46.7% vs 12.6%; odds ratio = 14.68; 95% CI, 5.38–40.05), and the 7-day point prevalence of abstinence rates were higher for varenicline versus placebo at week 12 (odds ratio = 13.76; 95% CI, 5.28–35.86). The number of participants with a ≥50% reduction in the number of daily cigarettes smoked from baseline to week 4 and a ≥75% reduction by week 8 was greater in the varenicline group versus the placebo group (week 4: 59.8% vs 30.1%; week 8: 38.3% vs 12.6%). Serious adverse events were reported in 3.7% of varenicline participants and 1.0% of placebo participants. Implications The efficacy and tolerability results of this analysis are consistent with those of the full varenicline reduce to quit study. Varenicline treatment and cigarette reduction before quitting may provide an alternative approach to smoking cessation in Japanese smokers who are not ready to quit immediately. ClinicalTrials.gov identifier: NCT01370356. |
| Databáze: | OpenAIRE |
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