Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial.
Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial.
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DOI：
10.1001/jama.2013.283185
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发表时间：
2014-01-08
影响因子：
120.7
通讯作者：
Hurt, Richard D.
中科院分区：
文献类型：
--
作者：
Ebbert, Jon O.;Hatsukami, Dorothy K.;Croghan, Ivana T.;Schroeder, Darrell R.;Allen, Sharon S.;Hays, J. Taylor;Hurt, Richard D.
联合药物治疗烟草依赖可能会增加戒烟。在吸烟者中确定与伐尼克兰单药治疗相比，伐尼克兰和缓释安非他酮联合治疗的有效性和安全性。2009年10月至2013年4月在中西部三家临床研究中心进行的随机、设盲、安慰剂对照多中心临床试验，治疗期为12周，随访期为52周。506名成年（≥ 18岁）吸烟者接受随机化，315名（62%）完成研究。12周：（1）伐尼克兰/安非他酮SR（联合治疗）;或（2）伐尼克兰/安慰剂（伐尼克兰单药治疗）。主要结局是第12周的长期（目标戒烟日期后2周不吸烟）和7天点患病率（过去7天不吸烟）戒烟率。次要结局是第26周和第52周的长期戒烟率和点患病率。结果经生化证实。在12周时，联合治疗组中53%的患者实现了长期戒烟，56.2%的患者实现了7天的点患病率戒烟，而伐尼克兰单药治疗组分别为43.2%和48.6（比值比[OR] 1.49，95%置信区间[CI]，1.05-2.12; P = 0.028和OR 1.36，95% CI，0.95-1.93; P = 0.090）。在26周时，联合治疗组中36.6%的患者实现了长期戒烟，38.2%的患者实现了7天的点患病率戒烟，而伐尼克兰单药治疗组分别为27.6%和31.9（OR 1.52，95% CI，1.04-2.22; P = 0.031和OR 1.32，95% CI，0.91-1.91; P = 0.14）。在52周时，联合治疗组中30.9%的患者实现了长期戒烟，36.6%的患者实现了7天的点患病率戒烟，而伐尼克兰单药治疗组分别为24.5%和29.2（分别为OR 1.39，95%CI，0.93-2.07; P = 0.106和OR 1.40，95%CI，0.96-2.05; P = 0.077）。接受联合治疗的参与者报告了更多的焦虑（7.2% vs 3.1%，P = 0.044）和抑郁症状（3.6% vs 0.8%; P = 0.034）。在吸烟者中，与单独使用伐尼克兰相比，联合使用伐尼克兰和安非他酮增加了12周和26周时的长期戒烟率，但未增加7天的点患病率; 52周时两种结局均无显著差异。需要进一步的研究来确定联合治疗在戒烟中的作用。
Combining pharmacotherapies for tobacco dependence treatment may increase smoking abstinence. Determine efficacy and safety of combination therapy with varenicline and sustained-release bupropion compared to varenicline monotherapy in cigarette smokers. Randomized, blinded, placebo-controlled multicenter clinical trial with a 12-week treatment period and 52-week follow-up conducted between October 2009 and April 2013 at three midwestern clinical research sites. Five hundred six adult (≥ 18 years) cigarette smokers were randomized and 315 (62%) completed the study. Twelve weeks of: (1) varenicline/bupropion SR (combination therapy); or (2) varenicline/placebo (varenicline monotherapy). Primary outcome was the prolonged (no smoking from 2 weeks after the target quit date) and 7-day point-prevalence (no smoking past 7 days) abstinence rates at week 12. Secondary outcomes were prolonged and point-prevalence smoking abstinence rates at weeks 26 and 52. Outcomes were biochemically-confirmed. At 12 weeks, 53% of the combination therapy group achieved prolonged and 56.2% achieved 7-day point-prevalence smoking abstinence compared to 43.2% and 48.6% in varenicline monotherapy (odds ratio [OR] 1.49, 95% confidence interval [CI], 1.05–2.12; P = .028 and OR 1.36, 95% CI, 0.95–1.93; P = .090, respectively). At 26 weeks, 36.6% of the combination therapy group achieved prolonged and 38.2% achieved 7-day point-prevalence smoking abstinence compared to 27.6% and 31.9% in varenicline monotherapy (OR 1.52, 95% CI, 1.04–2.22; P = .031 and OR 1.32, 95% CI, 0.91–1.91; P = .14, respectively). At 52 weeks, 30.9% of the combination therapy group achieved prolonged and 36.6% achieved 7-day point-prevalence smoking abstinence compared to 24.5% and 29.2% in varenicline monotherapy (OR 1.39, 95% CI, 0.93–2.07; P = .106 and OR 1.40, 95% CI, 0.96–2.05; P = .077, respectively). Participants receiving combination therapy reported more anxiety (7.2% vs 3.1%, P = .044) and depressive symptoms (3.6% vs 0.8%; P = .034). Among cigarette smokers, combined use of varenicline and bupropion, compared with varenicline alone, increased prolonged abstinence but not 7-day point prevalence at 12 and 26 weeks; neither outcome was significantly different at 52 weeks. Further research is required to determine the role of combination treatment in smoking cessation.
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影响因子：
2.2
作者：
Croghan, Ivana T.;Trautman, Judith A.;Hurt, Richard D.
通讯作者：
Hurt, Richard D.
影响因子：
5.9
作者：
Meyers, AW;Klesges, RC;Eck, LH
通讯作者：
Eck, LH
DOI：
10.1001/archfami.2.4.417
发表时间：
1993-04-01
期刊：
Archives of family medicine
影响因子：
--
作者：
Foulds, J;Stapleton, J;Costello, J
通讯作者：
Costello, J
影响因子：
4.7
作者：
Ebbert, Jon O.;Croghan, Ivana T.;Hurt, Richard D.
通讯作者：
Hurt, Richard D.
影响因子：
3.9
作者：
Obach, RS;Reed-Hagen, AE;Coe, JW
通讯作者：
Coe, JW