Pirlog Alina-Maria, Pirlog Cristian Daniel, Maghiar Marius Adrian
University of Oradea, Faculty of Medicine and Pharmacy, Department of General Medicine, Oradea, Romania.
University of Oradea, Faculty of Medicine and Pharmacy, Department of Dentistry, Oradea, Romania.
Open Access Maced J Med Sci. 2019 Apr 14;7(7):1226-1232. doi: 10.3889/oamjms.2019.289. eCollection 2019 Apr 15.
The purpose of this article was to systematically review the literature assessing the efficacy and safety of phase III clinical trials for each direct oral anticoagulant versus vitamin K antagonists and to design a "go-to" table for the prescriber.
A systematic review of specialist literature was conducted to identify RCTs which compared direct oral anticoagulants (DOACs) with standard warfarin treatment. Medline, Em-base, and the Cochrane databases were searched from January 2005- January 2019. The inclusion criteria were randomised controlled trials of oral anticoagulants in patients with non-valvular atrial fibrillation (NVAF). Four publications were phase III randomised control trials (RCTs) included in the final analysis.
Regarding the primary outcome in RELY the results were 1.69% per 100-year patients (p/y) for Warfarin compared to 1.11% p/y dabigatran etexilate 150mg BD (twice daily). In ROCKET AF the rates of the primary outcome were 2.2% p/y for warfarin compared to 1.7% p/y for rivaroxaban 20 mg OD (once daily). In ARISTOTLE trial the rates of the primary outcome were 1.60% p/y for warfarin compared to 1.27% p/y for apixaban 5 mg BD. In ENGAGE AF TIMI, the rates of the primary outcome were 1.50% p/y for warfarin compared to 1.18% p/y for edoxaban 60mg BD.
DOACs showed to be either noninferior or superior to warfarin with regards to the primary outcome with better safety patterns. Our "go-to" table provides a supportive tool for physicians in preventing medical errors when managing patients on oral anticoagulants.
本文旨在系统回顾评估每种直接口服抗凝剂与维生素K拮抗剂进行III期临床试验的疗效和安全性的文献，并为开处方者设计一个“实用”表格。
对专业文献进行系统回顾，以确定将直接口服抗凝剂（DOACs）与标准华法林治疗进行比较的随机对照试验。检索了2005年1月至2019年1月的Medline、Em-base和Cochrane数据库。纳入标准为非瓣膜性心房颤动（NVAF）患者口服抗凝剂的随机对照试验。四项出版物为最终分析中纳入的III期随机对照试验（RCTs）。
关于RELY试验的主要结局，华法林每100患者年（p/y）的发生率为1.69%，而达比加群酯150mg每日两次（BD）为每100患者年1.11%。在ROCKET AF试验中，主要结局的发生率华法林为每100患者年2.2%，而利伐沙班20mg每日一次（OD）为每100患者年1.7%。在ARISTOTLE试验中，主要结局的发生率华法林为每100患者年1.60%，而阿哌沙班5mg每日两次为每100患者年1.27%。在ENGAGE AF TIMI试验中，主要结局的发生率华法林为每100患者年1.50%，而依度沙班60mg每日两次为每100患者年1.18%。
在主要结局方面，DOACs显示出不劣于或优于华法林，且安全性更好。我们的“实用”表格为医生在管理口服抗凝剂患者时预防医疗差错提供了一个支持工具。
