An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use.

An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use.
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DOI:
10.1111/add.14250
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发表时间:
2018-04-21
期刊:
Addiction (Abingdon, England)
影响因子:
--
通讯作者:
Karam-Hage M
Karam-Hage M
中科院分区:
其他
文献类型:
--
作者:
Cinciripini PM;Minnix JA;Green CE;Robinson JD;Engelmann JM;Versace F;Wetter DW;Shete S;Karam-Hage M

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Despite the availability of several efficacious smoking cessation treatments, less than 25% of smokers who quit remain abstinent 1 year post treatment. This study aimed to determine if varenicline and bupropion combination treatment would result in higher abstinence rates than varenicline alone. A double-blind, randomized, parallel groups smoking cessation clinical trial in which participants were exposed to 12 weeks of treatment and followed for 12 months. Hospital-based outpatient clinic in Texas, USA specializing in cancer prevention. 385 community smokers (56% male) who smoked 1 pack cigarettes/day (Mean = 19.66 cigs/day, S.D. = 9.45); had an average CO of 26.43 ppm (S.D. =13.74); and were moderately dependent (FTCD = 4.79; S.D. = 2.07). Smokers were randomized in a 3:1 (Active: Placebo) ratio to 12 weeks of treatment as follows: Placebo (n=56), Varenicline (Var; n=166), and Varenicline + Bupropion (Combo; n=163). A priori primary outcome: Prolonged abstinence at 12 months. Secondary outcomes: Seven-day point prevalence abstinence and continuous abstinence; all abstinence measures at end of treatment and 6 month follow-ups. Intent to treat analysis: the Combo group (n=163) failed to demonstrate superiority to the Var group (n=166) for prolonged abstinence at 12 months [odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.50–1.64], supported by Bayes Factor = 0.06. Both the Var [OR = 6.66, 95% CI = 1.61–59.27] and Combo groups [OR = 6.06, 95% CI = 1.45–54.09] demonstrated superiority to Placebo group (n=56; Score = 8.38, p< 0.016). The addition of bupropion to varenicline treatment does not appear to increase smoking abstinence rates above that of varenicline alone. The findings support previous research showing a consistently favorable effect of both varenicline and the combination of varenicline and bupropion on smoking cessation compared with placebo.
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