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首页> 美国卫生研究院文献>Springer Open Choice >Net clinical benefit of dabigatran vs. warfarin in venous thromboembolism: analyses from RE-COVER® RE-COVER™ II and RE-MEDY™
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Net clinical benefit of dabigatran vs. warfarin in venous thromboembolism: analyses from RE-COVER® RE-COVER™ II and RE-MEDY™

机译：达比加群与华法林在静脉血栓栓塞中的临床净收益：来自RE-COVER®RE-COVER™II和RE-MEDY™的分析

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The direct oral anticoagulants, e.g., dabigatran etexilate (DE), are effective and well tolerated treatments for venous thromboembolism (VTE). Net clinical benefit (NCB) is a useful concept in weighing potential benefits against potential harm of comparator drugs. The NCB of DE vs. warfarin in VTE treatment was compared. Post-hoc analyses were performed on pooled data from the 6-month RE-COVER® and RE-COVER™ II trials, and data from the RE-MEDY™ trial (up to 36 months), to compare the NCB of DE (150 mg twice daily) and warfarin [target international normalized ratio (INR) 2.0–3.0]. Patients (≥18 years old) had symptomatic proximal deep vein thrombosis and/or pulmonary embolism. NCB was the composite of cardiovascular endpoints (non-fatal events of recurrent VTE, myocardial infarction, stroke or systemic embolism), all-cause death, and bleeding outcomes, all weighted equally. A broad definition of NCB included major bleeding events (MBE) and clinically relevant non-major bleeding events as bleeding outcomes, while a narrow definition included just MBE. The pooled dataset totalled 5107 patients from RE-COVER/RE-COVER II and 2856 patients from RE-MEDY. When NCB was narrowly defined, NCB was similar between DE and warfarin. When broadly defined, NCB was superior with DE vs. warfarin [RE-COVER/RE-COVER II, hazard ratio (HR) 0.80; 95% confidence interval (CI), 0.68–0.95 and RE-MEDY, HR 0.73; 95% CI 0.59–0.91]. These findings were unaffected by warfarin time in therapeutic range. The NCB of DE was similar or superior to warfarin, depending on the NCB definition used, regardless of the quality of INR control.
机译：直接口服抗凝药，例如达比加群酯（DE），是静脉血栓栓塞（VTE）的有效且耐受性良好的治疗方法。净临床收益（NCB）是权衡潜在收益与比较药物潜在危害之间的有用概念。比较了DE与华法林在VTE治疗中的NCB。对来自六个月的RE-COVER®和RE-COVER™II试验的汇总数据以及来自RE-MEDY™试验（长达36个月）的数据进行事后分析，以比较DE的NCB（150每天两次）和华法林[目标国际标准化比率（INR）2.0-3.0]。患者（≥18岁）有症状的近端深静脉血栓形成和/或肺栓塞。 NCB是心血管终点（反复发作的VTE，心肌梗塞，中风或全身性栓塞的非致命事件），全因死亡和出血结局的综合指标，均加权平均。 NCB的广义定义包括主要出血事件（MBE）和临床相关的非重大出血事件作为出血结果，而狭义定义仅包括MBE。汇总的数据集总计来自RE-COVER / RE-COVER II的5107例患者和来自RE-MEDY的2856例患者。当狭义地定义NCB时，DE和华法林之间的NCB相似。广义上讲，NCB优于DE优于华法林[RE-COVER / RE-COVER II，危险比（HR）为0.80； 95％置信区间（CI）为0.68-0.95，RE-MEDY为HR 0.73； 95％CI 0.59–0.91]。这些发现不受治疗范围内华法林时间的影响。 DE的NCB与华法林相似或优于华法林，这取决于所使用的NCB定义，而与INR控制的质量无关。

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