Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial.
Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial.
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DOI：
10.1001/jama.2015.280
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发表时间：
2015-02-17
期刊：
影响因子：
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通讯作者：
Park PW
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文献类型：
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作者：
Ebbert JO;Hughes JR;West RJ;Rennard SI;Russ C;McRae TD;Treadow J;Yu CR;Dutro MP;Park PW
一些吸烟者可能不准备立即戒烟，但可能愿意减少吸烟量以达到戒烟的目的。确定伐尼克兰通过减少吸烟增加戒烟率的有效性和安全性。2011年7月至2013年7月在10个国家的61个中心进行的随机、设盲、安慰剂对照、多国临床试验，治疗期为24周，随访期为28周。通过广告招募了1510名不愿意或不能在未来一个月内戒烟，但愿意在未来3个月内减少吸烟并尝试戒烟的吸烟者。伐尼克兰滴定至1 mg每日两次或安慰剂治疗24周，目标为4周时吸烟数量减少≥ 50%，8周时吸烟数量减少≥ 75%，12周时尝试戒烟。主要疗效终点是第15-24周期间一氧化碳（CO）证实的自我报告戒烟。次要结局是第21-24周和第21-52周经CO确认的自我报告的戒烟率。伐尼克兰组（N = 760）在第15-24周的持续戒烟率显著高于安慰剂组（N = 750）（32.1% vs 6.9%;风险差异（RD）25.2%; 95% CI 21.4%，29.0%;相对风险（RR）= 4.6; 95% CI 3.5，6.1）。在第21-24周，伐尼克兰组的持续戒烟率显著高于安慰剂组（37.8% vs 12.5%; RD 25.2%; 95 CI 21.1%，29.4%; RR 3.0; 95% CI 2.4，3.7）和第21-52周（27.0% vs 9.9%; RD 17.1%; 95% CI 13.3%，20.9%; RR 2.7; 95% CI 2.1，3.5）。伐尼克兰组和安慰剂组的严重不良事件发生率分别为3.7%和2.2%（P = 0.07）。在不愿意或不能在接下来的一个月内戒烟，但愿意减少吸烟量并在接下来的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周显著增加了6个月的戒烟率。伐尼克兰提供了一种治疗选择的吸烟者的需要没有解决的临床指南建议突然戒烟。www.clinicaltrials.gov（NCT01370356）：https://clinicaltrials.gov/ct2/results? term= NCT 01370356 & Search =搜索
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 efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction. Randomized, blinded, 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. 1510 cigarette smokers 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 recruited through advertising. Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with reduction target of ≥ 50% in number of cigarettes smoked by 4 weeks and ≥ 75% by 8 weeks and a quit attempt by 12 weeks. Primary efficacy endpoint was carbon monoxide (CO)-confirmed self-reported abstinence during weeks 15-24. Secondary outcomes were CO-confirmed self-reported abstinence rate for weeks 21-24 and weeks 21-52. The varenicline group (N = 760) had significantly higher continuous abstinence rates during weeks 15-24 versus placebo (N = 750) (32.1% vs 6.9%; 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 versus placebo during weeks 21-24 (37.8% vs 12.5%; RD 25.2%; 95 CI 21.1%, 29.4%; RR 3.0; 95% CI 2.4, 3.7) and weeks 21-52 (27.0% vs 9.9%; 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% and 2.2% of the varenicline and placebo groups, respectively (P = 0.07). Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt in the next 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates through 6 months of follow up. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation. www.clinicaltrials.gov (NCT01370356): https://clinicaltrials.gov/ct2/results?term=NCT01370356&Search=Search