A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates.
A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates.
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DOI：
10.1093/ntr/ntr220
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发表时间：
2012-03
期刊：
影响因子：
--
通讯作者：
Flexible Quit Date Study Group
中科院分区：
文献类型：
--
作者：
Rennard S;Hughes J;Cinciripini PM;Kralikova E;Raupach T;Arteaga C;St Aubin LB;Russ C;Flexible Quit Date Study Group
目前的戒烟指南建议在开始药物治疗之前设定戒烟日期。然而，在戒烟日期上提供灵活性可能更容易被一些吸烟者接受。本研究的目的是比较伐尼克兰1 mg每日两次（b.i.d.）在开始用药后使用灵活戒烟日期范例的受试者中使用安慰剂。在这项双盲、随机、安慰剂对照的国际研究中，年龄18-75岁、吸烟≥10支/天、有戒烟动机的吸烟者随机（3：1）接受伐尼克兰1 mg b.i.d.或安慰剂治疗12周。受试者随访至第24周。指导受试者在开始给药后第8天至第35天之间戒烟。主要终点是第9-12周期间经一氧化碳证实的持续戒烟，关键次要终点是第9-24周期间的持续戒烟。总体而言，493名受试者随机接受伐尼克兰治疗，166名接受安慰剂治疗。在治疗结束时，伐尼克兰组的持续戒断率高于安慰剂组（第9-12周：53.1% vs. 19.3%;比值比[OR] 5.9; 95% CI，3.7-9.4; p < .0001）和24周随访（第9-24周：34.7% vs. 12.7%; OR 4.4; 95% CI，2.6-7.5; p < .0001）。严重不良事件发生在1.2%的伐尼克兰（无精神病）和0.6%的安慰剂受试者中。报告抑郁相关不良事件的伐尼克兰受试者少于安慰剂受试者（分别为2.3%和6.7%）。伐尼克兰1 mg b.i.d.使用灵活的戒烟日期范例与先前的固定戒烟日期研究相比具有相似的功效和安全性。
Current smoking cessation guidelines recommend setting a quit date prior to starting pharmacotherapy. However, providing flexibility in the date of quitting may be more acceptable to some smokers. The objective of this study was to compare varenicline 1 mg twice daily (b.i.d.) with placebo in subjects using a flexible quit date paradigm after starting medication. In this double-blind, randomized, placebo-controlled international study, smokers of ≥10 cigarettes/day, aged 18–75 years, and who were motivated to quit were randomized (3:1) to receive varenicline 1 mg b.i.d. or placebo for 12 weeks. Subjects were followed up through Week 24. Subjects were instructed to quit between Days 8 and 35 after starting medication. The primary endpoint was carbon monoxide–confirmed continuous abstinence during Weeks 9–12, and a key secondary endpoint was continuous abstinence during Weeks 9–24. Overall, 493 subjects were randomized to varenicline and 166 to placebo. Continuous abstinence was higher for varenicline than for placebo subjects at the end of treatment (Weeks 9–12: 53.1% vs. 19.3%; odds ratio [OR] 5.9; 95% CI, 3.7–9.4; p < .0001) and through 24 weeks follow-up (Weeks 9–24: 34.7% vs. 12.7%; OR 4.4; 95% CI, 2.6–7.5; p < .0001). Serious adverse events occurred in 1.2% varenicline (none were psychiatric) and 0.6% placebo subjects. Fewer varenicline than placebo subjects reported depression-related adverse events (2.3% vs. 6.7%, respectively). Varenicline 1 mg b.i.d. using a flexible quit date paradigm had similar efficacy and safety compared with previous fixed quit date studies.
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