Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation A Randomized Clinical Trial
Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation A Randomized Clinical Trial
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DOI：
10.1001/jama.2021.15333
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发表时间：
2021-10-19
影响因子：
120.7
通讯作者：
Fiore, Michael C.
中科院分区：
文献类型：
--
作者：
Baker, Timothy B.;Piper, Megan E.;Fiore, Michael C.
与仅使用伐尼克兰的标准治疗时间相比，联合使用伐尼克兰与尼古丁贴片或延长戒烟治疗时间是否能提高戒烟效果？在这项随机临床试验中，1251名参与者每天吸烟5支或更多，使用伐尼克兰单药治疗12周，伐尼克兰加尼古丁贴片治疗12周，伐尼克兰单药治疗24周，伐尼克兰加尼古丁贴片治疗24周，在52周时，7天点流行戒断率分别为25.1%,23.6%，24.4%和25.1%。这些比较都没有统计学意义。意思是这些发现不支持使用伐尼克兰加尼古丁贴片联合疗法与伐尼克兰单一疗法或24周与12周治疗戒烟。戒烟药物在医疗保健中是常规使用的。研究表明，将伐尼克兰与尼古丁贴片结合，延长伐尼克兰治疗的持续时间，或两者兼而有之，可能会提高戒烟效果。目的比较伐尼克兰联合尼古丁或安慰剂贴片与联合使用12周（标准持续时间）或24周（延长持续时间）的疗效。设计、设置和参与者：2017年11月11日至2020年7月9日，在威斯康星州麦迪逊市的1家研究诊所和威斯康星州密尔沃基市的1家诊所进行双盲、2 × 2因子随机临床试验。在被要求参加这项研究的5836名成年人中，1251名每天吸烟5支或更多的人被随机分组。所有参与者都接受了戒烟咨询，并被随机分为4个药物组：伐尼克兰单药治疗12周（n = 315），伐尼克兰加尼古丁贴片治疗12周（n = 314），伐尼克兰单药治疗24周（n = 311），或伐尼克兰加尼古丁贴片治疗24周（n = 311）。主要结局和测量主要结局是52周时一氧化碳确诊自我报告的7天点流行戒断。结果1251例随机分组患者（平均[SD]年龄49.1[11.9]岁，女性675例[54.0%]）中，751例（60.0%）完成治疗，881例（70.4%）提供最终随访。对于主要结局，用药类型和用药时间这两个治疗因素之间没有显著的相互作用（优势比[OR]， 1.03 [95% CI, 0.91 ~ 1.17]; P = 0.66）。对于随机分配到24周和12周治疗时间的患者，主要结局分别为24.8%（154/622）和24.3%(153/629)（风险差异为-0.4% [95% CI, -5.2%至4.3%]；OR为1.01 [95% CI， 0.89至1.15]）。对于随机接受伐尼克兰联合治疗和伐尼克兰单药治疗的患者，主要结局分别为24.3%（152/625）和24.8%(155/626)（风险差异为0.4% [95% CI, -4.3%至5.2%]；OR为0.99 [95% CI， 0.87至1.12]）。四组患者恶心发生率从24.0%到30.9%不等，失眠发生率从24.4%到30.5%不等。结论和相关性在每天吸烟5支或以上的成年人中，在52周时，伐尼克兰联合尼古丁贴片治疗与伐尼克兰单药治疗，或治疗24周与12周之间，7天点流行戒烟无显著差异。这些发现不支持使用联合治疗或延长治疗时间。这项随机临床试验比较了伐尼克兰加尼古丁或安慰剂贴片的组合与使用12周（标准持续时间）或24周（延长持续时间）戒烟的成年人，他们每天吸烟5支或更多。
Question Does combining varenicline with the nicotine patch or extending cessation treatment duration increase smoking abstinence compared with the standard length of therapy with varenicline only? Findings In this randomized clinical trial that included 1251 participants smoking 5 cigarettes/d or more, treatment with varenicline monotherapy for 12 weeks, varenicline plus nicotine patch for 12 weeks, varenicline monotherapy for 24 weeks, and varenicline plus nicotine patch for 24 weeks resulted in 7-day point prevalence abstinence rates at 52 weeks of 25.1%, 23.6%, 24.4%, and 25.1%, respectively. None of the comparisons was statistically significant. Meaning These findings do not support the use of combined varenicline plus nicotine patch vs varenicline monotherapy or of 24-week vs 12-week treatment for smoking cessation.Importance Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants Double-blind, 2 x 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.This randomized clinical trial compares combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration) for smoking cessation in adults who smoked 5 cigarettes/d or more.