Nakamura Masakazu, Abe Masaaki, Ohkura Masayuki, Treadow Joan, Yu Ching-Ray, Park Peter W
Health Promotion Research Center, Institute of Committee Medicine, Japan Association for Development of Community Medicine, Tokyo, Japan.
Pfizer Japan Inc, Tokyo, Japan.
Clin Ther. 2017 Apr;39(4):863-872. doi: 10.1016/j.clinthera.2017.03.007. Epub 2017 Mar 30.
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.
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.
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.
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.
本研究对伐尼克兰减量戒烟研究中的日本亚组人群进行前瞻性分析，以评估日本参与者的结果是否与整个研究人群一致。
患者接受伐尼克兰或安慰剂治疗24周（12周的减少吸烟阶段，然后是12周的戒烟阶段），随后是28周的非治疗随访阶段。参与者要在第4周时将每日吸烟量减少至少50%，并在第8周时再减少50%，目标是在第12周实现完全戒烟。主要疗效终点是第15至24周经一氧化碳确认的持续戒烟情况。
总体而言，210名日本患者被随机分配到2个研究组中的1组（伐尼克兰组107人；安慰剂组103人）。伐尼克兰组参与者在第15至24周的持续戒烟率高于安慰剂组（46.7%对12.6%；优势比=14.68；95%置信区间，5.38 - 40.05），且在第12周时，伐尼克兰组的7天戒烟率点患病率高于安慰剂组（优势比=13.76；95%置信区间，5.28 - 35.86）。从基线到第4周每日吸烟量减少≥50%且到第8周减少≥75%的参与者数量，伐尼克兰组多于安慰剂组（第4周：59.8%对30.1%；第8周：38.3%对12.6%）。3.7%的伐尼克兰参与者和1.0%的安慰剂参与者报告了严重不良事件。
该分析的疗效和耐受性结果与整个伐尼克兰减量戒烟研究的结果一致。对于尚未准备好立即戒烟的日本吸烟者，伐尼克兰治疗和戒烟前减少吸烟量可能提供一种替代的戒烟方法。ClinicalTrials.gov标识符：NCT01370356。
