Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial.
Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial.
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DOI：
10.1161/circulationaha.109.869008
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发表时间：
2010-01-19
期刊：
影响因子：
37.8
通讯作者：
Tonstad S
中科院分区：
文献类型：
--
作者：
Rigotti NA;Pipe AL;Benowitz NL;Arteaga C;Garza D;Tonstad S
戒烟是心血管疾病二级预防的关键组成部分。 Varenicline 是一种部分 α4β2 烟碱乙酰胆碱受体激动剂，对健康吸烟者戒烟有效，但其对患有心血管疾病的吸烟者的有效性和安全性尚不清楚。一项多中心、随机、双盲、安慰剂对照试验比较了伐尼克兰与安慰剂对 714 名患有稳定心血管疾病的吸烟者戒烟的疗效和安全性。参与者接受伐尼克兰（1 毫克，每天两次）或安慰剂，以及戒烟咨询，为期 12 周。随访持续52周。主要终点是确认第 9 周至第 12 周（治疗最后 4 周）的一氧化碳持续戒断率。第 9 至 12 周期间，伐尼克兰的持续戒断率高于安慰剂（47.0% 对比 13.9%；优势比，6.11；95% 置信区间 [CI]，4.18 至 8.93）和第 9 至 52 周（19.2% 对比 7.2%；优势比，3.14；95% CI，1.93 至5.11）。伐尼克兰组和安慰剂组在心血管死亡率（0.3%对0.6%；差异，-0.3%；95% CI，-1.3至0.7）、全因死亡率（0.6%对1.4%；差异，-0.8%；95% CI，-2.3至0.6）、心血管事件（7.1%对5.7%；差异，1.4%）和心血管事件（7.1%对5.7%；差异，1.4%）方面没有显着差异。 95% CI，-2.3 至 5.0），或严重不良事件（6.5% 和 6.0%；差异，0.5%；95% CI，-3.1 至 4.1）。由于不良事件的发生，9.6% 的伐尼克兰和 4.3% 的安慰剂参与者停止了研究药物。伐尼克兰对于患有心血管疾病的吸烟者戒烟有效。它具有良好的耐受性，不会增加心血管事件或死亡率；然而，试验规模和持续时间限制了有关安全性的明确结论。网址：http://www.clinicaltrials.gov/ct2/show/NCT00282984。唯一标识符：NCT00282984
Smoking cessation is a key component of secondary cardiovascular disease prevention. Varenicline, a partial α4β2 nicotinic acetylcholine receptor agonist, is effective for smoking cessation in healthy smokers, but its efficacy and safety in smokers with cardiovascular disease are unknown. A multicenter, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease. Participants received varenicline (1 mg twice daily) or placebo, along with smoking-cessation counseling, for 12 weeks. Follow-up lasted 52 weeks. The primary end point was carbon monoxide–confirmed continuous abstinence rate for weeks 9 through 12 (last 4 weeks of treatment). The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 (47.0% versus 13.9%; odds ratio, 6.11; 95% confidence interval [CI], 4.18 to 8.93) and weeks 9 through 52 (19.2% versus 7.2%; odds ratio, 3.14; 95% CI, 1.93 to 5.11). The varenicline and placebo groups did not differ significantly in cardiovascular mortality (0.3% versus 0.6%; difference, −0.3%; 95% CI, −1.3 to 0.7), all-cause mortality (0.6% versus 1.4%; difference, −0.8%; 95% CI, −2.3 to 0.6), cardiovascular events (7.1% versus 5.7%; difference, 1.4%; 95% CI, −2.3 to 5.0), or serious adverse events (6.5% and 6.0%; difference, 0.5%; 95% CI, −3.1 to 4.1). As a result of adverse events, 9.6% of varenicline and 4.3% of placebo participants discontinued study drug. Varenicline is effective for smoking cessation in smokers with cardiovascular disease. It was well tolerated and did not increase cardiovascular events or mortality; however, trial size and duration limit definitive conclusions about safety. URL: http://www.clinicaltrials.gov/ct2/show/NCT00282984. Unique identifier: NCT00282984