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首页> 外文期刊>The New England journal of medicine >Dabigatran versus warfarin in patients with atrial fibrillation.
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Dabigatran versus warfarin in patients with atrial fibrillation.

机译：房颤患者的达比加群与华法林比较。

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BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)
机译：背景：华法令降低了房颤患者中风的风险，但增加了出血的风险，难以使用。达比加群是一种新型口服直接凝血酶抑制剂。方法：在这项非劣效性试验中，我们随机分配了18113名患有房颤和中风风险的患者，以盲方方式接受固定剂量的达比加群（110 mg或150 mg每天两次）或以无盲方式接受，调整剂量的华法令。随访期的中位时间为2。0年。主要结果是中风或全身性栓塞。结果：华法林组的主要结局率为每年1.69％，而接受达比加群110 mg的组为每年1.53％（达比加群的相对风险为0.91; 95％的置信区间[CI]为0.74）至1.11;非劣效性P <0.001）和接受150毫克达比加群的组每年1.11％（相对危险度，0.66; 95％CI，0.53至0.82;优越性P <0.001）。华法林组每年的主要出血率为3.36％，而接受110毫克达比加群（P = 0.003）的组为每年2.71％，而接受150毫克达比加群（P的组每年为3.11％ = 0.31）。华法林组每年出血性中风的发生率为0.38％，相比之下，达比加群110 mg（P <0.001）每年为0.12％，达比加群150 mg（P <0.001）每年为0.10％。华法林组的死亡率为每年4.13％，相比之下，达比加群110 mg（P = 0.13）每年为3.75％，达比加群150 mg（P = 0.051）每年为3.64％。结论：在房颤患者中，达比加群以110 mg的剂量与中风和全身性栓塞的发生率（与华法林相关）相似，并且大出血发生率较低。与华法林相比，达比加群以150 mg的剂量与中风和全身性栓塞的发生率较低，但大出血发生率相似。 （ClinicalTrials.gov编号，NCT00262600。）

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