达比加群、阿哌沙班、利伐沙班、依度沙班、华法林比较有效性研究方案。
Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study.
机构信息
Division of Pharmacoepidemiology & Pharmacoeconomics, Department of Medicine, Brigham & Women's Hospital & Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA.
出版信息
J Comp Eff Res. 2018 Jan;7(1):57-66. doi: 10.2217/cer-2017-0053. Epub 2017 Dec 21.
UNLABELLED
Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations. As our population includes Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, our results will likely be transportable to the majority of US patients experiencing a DVT or pulmonary embolism.
CLINICAL TRIALS REGISTRATION
NCT03271450.
未标注
自 2010 年以来，除了华法林之外，还有 4 种口服抗凝剂被批准用于治疗血栓栓塞性疾病。这些治疗方法之间的头对头数据有限，这使得患者和临床医生几乎没有指导来选择一种既能降低复发风险又能降低出血风险的策略。在达比加群、阿哌沙班、利伐沙班、依度沙班和华法林的比较有效性研究中，我们比较了目前所有 5 种可用于深静脉血栓和肺栓塞的延长治疗的口服抗凝药物，以及无延长治疗的情况，并评估了在特定亚人群中结果是否存在差异。由于我们的研究人群包括使用新型抗凝药物的 Medicare 患者以及大量商业保险和医疗补助患者，因此我们的研究结果很可能适用于大多数经历深静脉血栓或肺栓塞的美国患者。
临床试验注册
NCT03271450。
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