Servicio de Cardiología, Hospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain.
Servicio de Cardiología, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Clin Drug Investig. 2021 Nov;41(11):941-953. doi: 10.1007/s40261-021-01091-w. Epub 2021 Oct 13.
Real-life data about the use of dabigatran in patients with non-valvular atrial fibrillation are warranted. The objective of this systematic review and meta-analysis was to assess the effectiveness and safety of dabigatran, globally and stratified by dose (110/150 mg twice daily), vs vitamin K antagonists in non-Asian patients with non-valvular atrial fibrillation from "real-world" studies.
A systematic review was performed according to Cochrane methodological standards. The results were reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses Statement) statement. The ROBINS-I tool was used to assess bias risk. MEDLINE and EMBASE, from inception up to May 2021, using appropriate controlled vocabulary and free search terms, were searched. RESULTS: A total of 34 studies, corresponding to 37 articles involving 1,600,722 participants (1,154,283 exposed to vitamin K antagonists and 446,439 to dabigatran) were eligible for this review. Dabigatran 150 mg reduced the risk of ischemic stroke compared with vitamin K antagonists, with a 14% risk reduction (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.74-0.98). Globally, dabigatran reduced the risk of all-cause mortality compared with vitamin K antagonists (HR 0.76, 95% CI 0.69-0.84), with a greater effect observed with dabigatran 150 mg (HR 0.65, 95% CI 0.58-0.73). There was a trend towards a lower risk of myocardial infarction with dabigatran 150 mg (HR 0.86, 95% CI 0.71-1.04). Regarding the primary safety outcomes, dabigatran (either at a dose of 150 mg or 110 mg) reduced the risk of major bleeding compared with vitamin K antagonists (HR 0.77, 95% CI 0.70-0.83), as well as the risk of intracranial bleeding (HR 0.44, 95% CI 0.39-0.50) and fatal bleeding (HR 0.76, 95% CI 0.60-0.95), but with a slight increase in gastrointestinal bleeding risk (HR 1.16, 95% CI 1.08-1.26).
Dabigatran has a favorable impact on effectiveness and safety outcomes compared with vitamin K antagonists in real-world populations.
需要真实世界的数据来评估达比加群在非瓣膜性心房颤动患者中的应用。本系统评价和荟萃分析的目的是评估达比加群（110/150mg，每日 2 次）与维生素 K 拮抗剂在非亚洲非瓣膜性心房颤动患者中的有效性和安全性，分层依据剂量。
根据 Cochrane 方法学标准进行系统评价。结果按照 PRISMA（系统评价和荟萃分析的首选报告项目）声明进行报告。使用 ROBINS-I 工具评估偏倚风险。从 MEDLINE 和 EMBASE 中检索从开始到 2021 年 5 月的研究，使用适当的受控词汇和自由搜索词。
共有 34 项研究，对应 37 篇文章，涉及 1600722 名参与者（1154283 名暴露于维生素 K 拮抗剂，446439 名暴露于达比加群）符合本综述的纳入标准。与维生素 K 拮抗剂相比，达比加群 150mg 降低了缺血性卒中风险，风险降低 14%（风险比[HR]0.86，95%置信区间[CI]0.74-0.98）。总体而言，与维生素 K 拮抗剂相比，达比加群降低了全因死亡率（HR 0.76，95%CI 0.69-0.84），达比加群 150mg 效果更大（HR 0.65，95%CI 0.58-0.73）。达比加群 150mg 降低心肌梗死风险的趋势（HR 0.86，95%CI 0.71-1.04）。关于主要安全性结局，达比加群（150mg 或 110mg 剂量）与维生素 K 拮抗剂相比，降低了大出血风险（HR 0.77，95%CI 0.70-0.83），颅内出血风险（HR 0.44，95%CI 0.39-0.50）和致命性出血风险（HR 0.76，95%CI 0.60-0.95），但胃肠道出血风险略有增加（HR 1.16，95%CI 1.08-1.26）。
达比加群在真实世界人群中的有效性和安全性结局优于维生素 K 拮抗剂。
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