Ebbert Jon O, Hughes John R, West Robert J, Rennard Stephen I, Russ Cristina, McRae Thomas D, Treadow Joan, Yu Ching-Ray, Dutro Michael P, Park Peter W
Mayo Clinic, Rochester, Minnesota.
Department of Psychiatry, University of Vermont, Burlington, Vermont.
JAMA. 2015 Feb 17;313(7):687-94. doi: 10.1001/jama.2015.280.
Some cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.
To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries. The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months. Participants were recruited through advertising.
Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50% or more in number of cigarettes smoked by 4 weeks, 75% or more by 8 weeks, and a quit attempt by 12 weeks.
Primary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24. Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52.
The varenicline group (n = 760) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group (n = 750) (32.1% for the varenicline group vs 6.9% for the placebo group; risk difference (RD), 25.2% [95% CI, 21.4%-29.0%]; relative risk (RR), 4.6 [95% CI, 3.5-6.1]). The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 (37.8% for the varenicline group vs 12.5% for the placebo group; RD, 25.2% [95% CI, 21.1%-29.4%]; RR, 3.0 [95% CI, 2.4-3.7]) and weeks 21 through 52 (27.0% for the varenicline group vs 9.9% for the placebo group; RD, 17.1% [95% CI, 13.3%-20.9%]; RR, 2.7 [95% CI, 2.1-3.5]). Serious adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P = .07).
Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment, and also at 1 year. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation.
clinicaltrials.gov Identifier: NCT01370356.
一些吸烟者可能尚未准备好立即戒烟，但可能愿意减少吸烟量以期最终戒烟。
确定伐尼克兰通过减少吸烟量来提高戒烟率的有效性和安全性。
设计、地点和参与者：随机、双盲、安慰剂对照的多国临床试验，治疗期为24周，随访期为28周，于2011年7月至2013年7月在10个国家的61个中心进行。1510名参与者为吸烟者，他们在下个月内不愿意或无法戒烟，但愿意减少吸烟量，并在接下来的3个月内尝试戒烟。参与者通过广告招募。
24周的伐尼克兰治疗，剂量滴定至每日两次，每次1毫克，或服用安慰剂，目标是在4周内吸烟量减少50%或更多，8周内减少75%或更多，并在12周内尝试戒烟。
主要疗效终点是第15周至24周经一氧化碳确认的自我报告的戒烟情况。次要结局是第21周至24周以及第21周至52周经一氧化碳确认的自我报告的戒烟情况。
伐尼克兰组（n = 760）在第15周至24周的持续戒烟率显著高于安慰剂组（n = 750）（伐尼克兰组为32.1%，安慰剂组为6.9%；风险差异（RD），25.2%[95%置信区间，21.4%-29.0%]；相对风险（RR），4.6[95%置信区间，3.5-6.1]）。伐尼克兰组在第21周至24周（伐尼克兰组为37.8%，安慰剂组为12.5%；RD，25.2%[95%置信区间，21.1%-29.4%]；RR，3.0[95%置信区间，2.4-3.7]）以及第21周至52周（伐尼克兰组为27.0%，安慰剂组为9.9%；RD，17.1%[95%置信区间，13.3%-20.9%]；RR，2.7[95%置信区间，2.1-3.5]）的持续戒烟率也显著高于安慰剂组。严重不良事件在伐尼克兰组中的发生率为3.7%，在安慰剂组中的发生率为2.2%（P = 0.07）。
在那些下个月内不愿意或无法戒烟，但愿意减少吸烟量并在3个月内尝试戒烟的吸烟者中，与安慰剂相比，使用伐尼克兰24周显著提高了治疗结束时以及1年后的戒烟率。对于那些临床指南推荐突然戒烟无法满足其需求的吸烟者，伐尼克兰提供了一种治疗选择。
clinicaltrials.gov标识符：NCT01370356。
