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Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2019-11-16 , DOI: 10.1056/nejmoa1912388
Jean-Claude Tardif 1 , Simon Kouz 1 , David D Waters 1 , Olivier F Bertrand 1 , Rafael Diaz 1 , Aldo P Maggioni 1 , Fausto J Pinto 1 , Reda Ibrahim 1 , Habib Gamra 1 , Ghassan S Kiwan 1 , Colin Berry 1 , José López-Sendón 1 , Petr Ostadal 1 , Wolfgang Koenig 1 , Denis Angoulvant 1 , Jean C Grégoire 1 , Marc-André Lavoie 1 , Marie-Pierre Dubé 1 , David Rhainds 1 , Mylène Provencher 1 , Lucie Blondeau 1 , Andreas Orfanos 1 , Philippe L L'Allier 1 , Marie-Claude Guertin 1 , François Roubille 1
Affiliation  

BACKGROUND Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis. METHODS We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed. RESULTS A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03). CONCLUSIONS Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).

中文翻译:

心肌梗塞后小剂量秋水仙碱的疗效和安全性。

背景技术实验和临床证据支持炎症在动脉粥样硬化及其并发症中的作用。秋水仙碱是一种口服有效的抗炎药,可用于治疗痛风和心包炎。方法我们进行了一项随机,双盲试验,涉及心肌梗死后30天内招募的患者。患者被随机分配接受低剂量秋水仙碱(每天0.5 mg)或安慰剂。主要功效终点是因心血管原因死亡,复苏的心脏骤停,心肌梗塞,中风或因冠心病血运重建而导致的心绞痛的紧急住院的综合结果。还评估了主要终点和安全性的组成部分。结果共有4745名患者入选;秋水仙碱组为2366例患者,安慰剂组为2379例。随访患者的中位时间为22.6个月。秋水仙碱组患者的主要终点发生率为5.5%,而安慰剂组为7.1%(危险比为0.77; 95%置信区间[CI]为0.61至0.96; P = 0.02)。死于心血管原因的危险比为0.84(95%CI,0.46至1.52),复苏的心脏骤停的危险比为0.83(95%CI,0.25至2.73),心肌梗塞的风险比为0.91(95%CI,0.68至1.21),0.26 (95%CI,0.10至0.70)用于中风,0.50(95%CI,0.31至0.81)用于因心绞痛导致冠状动脉血运重建的紧急住院。秋水仙碱组和安慰剂组分别有9.7%和8.9%的患者出现腹泻(P = 0.35)。秋水仙碱组中有0.9%的患者和安慰剂组中有0.4%的患者报告肺炎为严重不良事件(P = 0.03)。结论在最近有心肌梗塞的患者中,秋水仙碱每天0.5 mg的剂量导致缺血性心血管事件的危险性显着低于安慰剂。(由魁北克政府和其他政府资助; COLCOT ClinicalTrials.gov编号,NCT02551094。)。
更新日期:2019-12-26
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