Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center, Omaha, NE 68198-5910, USA.
Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
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.
目前的戒烟指南建议在开始药物治疗前设定戒烟日期。然而，为一些吸烟者提供灵活的戒烟日期可能更能被接受。本研究的目的是比较在开始药物治疗后采用灵活戒烟日期方案的情况下，每日吸烟≥10 支的 18-75 岁吸烟者使用伐仑克林 1mg 每日两次（bid）与安慰剂的疗效。
这是一项双盲、随机、安慰剂对照的国际研究，纳入了≥10 支/天的吸烟者，年龄 18-75 岁，有戒烟意愿。将这些吸烟者按照 3:1 的比例随机分为伐仑克林 1mg bid 组或安慰剂组，治疗 12 周。随访至第 24 周。指导受试者在开始药物治疗后第 8-35 天内戒烟。主要终点为治疗第 9-12 周时经过碳 monoxide 确认的持续戒烟率，关键次要终点为治疗第 9-24 周时的持续戒烟率。
共有 493 例受试者被随机分至伐仑克林组，166 例受试者分至安慰剂组。治疗结束时（第 9-12 周），伐仑克林组的持续戒烟率显著高于安慰剂组（53.1%比 19.3%；比值比[OR] 5.9；95%置信区间[CI]，3.7-9.4；p<0.0001），随访至第 24 周时（第 9-24 周）也更高（34.7%比 12.7%；OR 4.4；95% CI，2.6-7.5；p<0.0001）。伐仑克林组和安慰剂组分别有 1.2%（均非精神科相关）和 0.6%的受试者出现严重不良事件。伐仑克林组报告与抑郁相关的不良事件发生率（2.3%）低于安慰剂组（6.7%）。
与之前的固定戒烟日期研究相比，伐仑克林 1mg bid 采用灵活戒烟日期方案的疗效和安全性相当。
