血管紧张素受体脑啡肽酶抑制剂沙库巴曲缬沙坦钠片治疗原发性高血压的有效性和安全性：一项随机试验。
Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial.
机构信息
General Medicine Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Tobacco Research and Treatment Center, Boston, Mass 02114, USA.
出版信息
Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
BACKGROUND
Smoking cessation is a key component of secondary cardiovascular disease prevention. Varenicline, a partial alpha4beta2 nicotinic acetylcholine receptor agonist, is effective for smoking cessation in healthy smokers, but its efficacy and safety in smokers with cardiovascular disease are unknown.
METHODS AND RESULTS
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.
CONCLUSIONS
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. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov/ct2/show/NCT00282984. Unique identifier: NCT00282984.
背景
戒烟是二级心血管疾病预防的关键组成部分。伐伦克林是一种部分α4β2烟碱型乙酰胆碱受体激动剂，在健康吸烟者中戒烟效果显著，但在心血管疾病患者中的疗效和安全性尚不清楚。
方法和结果
一项多中心、随机、双盲、安慰剂对照试验比较了伐伦克林与安慰剂在 714 名稳定心血管疾病吸烟者中的戒烟疗效和安全性。参与者接受伐伦克林（1 毫克，每日 2 次）或安慰剂，同时接受戒烟咨询，持续 12 周。随访持续 52 周。主要终点为第 9 至 12 周（治疗最后 4 周）经一氧化碳证实的持续戒烟率。第 9 至 12 周，伐伦克林组的持续戒烟率高于安慰剂组（47.0%比 13.9%；比值比，6.11；95%置信区间[CI]，4.18 至 8.93）和第 9 至 52 周（19.2%比 7.2%；比值比，3.14；95%CI，1.93 至 5.11）。伐伦克林组和安慰剂组心血管死亡率（0.3%比 0.6%；差异，-0.3%；95%CI，-1.3 至 0.7）、全因死亡率（0.6%比 1.4%；差异，-0.8%；95%CI，-2.3 至 0.6）、心血管事件（7.1%比 5.7%；差异，1.4%；95%CI，-2.3 至 5.0）或严重不良事件（6.5%比 6.0%；差异，0.5%；95%CI，-3.1 至 4.1）均无显著差异。由于不良事件，9.6%的伐伦克林组和 4.3%的安慰剂组患者停止使用研究药物。
结论
伐伦克林可有效用于心血管疾病吸烟者戒烟。它耐受性良好，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对安全性的明确结论。临床试验注册信息- URL：http://www.clinicaltrials.gov/ct2/show/NCT00282984。独特标识符：NCT00282984。
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