IR@PKUHSC  > 北京大学第二临床医学院
学科主题临床医学
Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients
Cohen, Alexander T.1; Spiro, Theodore E.2; Buller, Harry R.4; Haskell, Lloyd3; Hu, Dayi5; Hull, Russell6; Mebazaa, Alexandre7; Merli, Geno8; Schellong, Sebastian9; Spyropoulos, Alex C.10; Tapson, Victor11; MAGELLAN Investigators
刊名NEW ENGLAND JOURNAL OF MEDICINE
2013-02-07
DOI10.1056/NEJMoa1111096
368期:6页:513-523
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
研究领域[WOS]General & Internal Medicine
关键词[WOS]PLACEBO-CONTROLLED TRIAL ; DEEP-VEIN THROMBOSIS ; VENOUS THROMBOEMBOLISM ; RISK-FACTORS ; PREVENTION ; PROPHYLAXIS ; ENOXAPARIN
英文摘要

Background

The clinically appropriate duration of thromboprophylaxis in hospitalized patients with acute medical illnesses is unknown. In this multicenter, randomized, double-blind trial, we evaluated the efficacy and safety of oral rivaroxaban administered for an extended period, as compared with subcutaneous enoxaparin administered for a standard period, followed by placebo.

Methods

We randomly assigned patients 40 years of age or older who were hospitalized for an acute medical illness to receive subcutaneous enoxaparin, 40 mg once daily, for 10 +/- 4 days and oral placebo for 35 +/- 4 days or to receive subcutaneous placebo for 10 +/- 4 days and oral rivaroxaban, 10 mg once daily, for 35 +/- 4 days. The primary efficacy outcomes were the composite of asymptomatic proximal or symptomatic venous thromboembolism up to day 10 (noninferiority test) and up to day 35 (superiority test). The principal safety outcome was the composite of major or clinically relevant nonmajor bleeding.

Results

A total of 8101 patients underwent randomization. A primary efficacy outcome event occurred in 78 of 2938 patients (2.7%) receiving rivaroxaban and 82 of 2993 patients (2.7%) receiving enoxaparin at day 10 (relative risk with rivaroxaban, 0.97; 95% confidence interval [CI], 0.71 to 1.31; P = 0.003 for noninferiority) and in 131 of 2967 patients (4.4%) who received rivaroxaban and 175 of 3057 patients (5.7%) who received enoxaparin followed by placebo at day 35 (relative risk, 0.77; 95% CI, 0.62 to 0.96; P = 0.02). A principal safety outcome event occurred in 111 of 3997 patients (2.8%) in the rivaroxaban group and 49 of 4001 patients (1.2%) in the enoxaparin group at day 10 (P<0.001) and in 164 patients (4.1%) and 67 patients (1.7%) in the respective groups at day 35 (P<0.001).

Conclusions

In acutely ill medical patients, rivaroxaban was noninferior to enoxaparin for standard-duration thromboprophylaxis. Extended-duration rivaroxaban reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding. (Funded by Bayer HealthCare Pharmaceuticals and Janssen Research and Development; MAGELLAN ClinicalTrials.gov number, NCT00571649.)

语种英语
WOS记录号WOS:000314494100002
资助机构Bayer ; Bristol-Myers Squibb ; Daiichi Sankyo ; Johnson Johnson ; Pfizer ; Portola ; Sanofi ; LEO Pharma ; Pronota ; Alere ; Edwards ; Orion ; Thermo Fisher ; Sanofi-Aventis ; Boehringer ; Ingelheim ; GlaxoSmithKline ; Novartis ; Sanofi Aventis ; Covidien ; Bayer HealthCare Pharmaceuticals ; Janssen Research and Development
引用统计
被引频次:228[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/60619
专题北京大学第二临床医学院
作者单位1.Kings Coll Hosp, London SE5 9RS, England
2.Bayer HealthCare Pharmaceut, Montville, NJ USA
3.Janssen Res & Dev, Raritan, NJ USA
4.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
5.Foothills Prov Gen Hosp, Calgary, AB T2N 2T9, Canada
6.Thomas Jefferson Med Ctr, Philadelphia, PA USA
7.Dresden Friedrichstadt Hosp, Dresden, Germany
8.Hofstra N Shore Long Isl Jewish Sch Med, Manhasset, NY USA
9.Duke Univ, Med Ctr, Durham, NC USA
10.Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
11.Hop Lariboisiere, F-75475 Paris, France
推荐引用方式
GB/T 7714
Cohen, Alexander T.,Spiro, Theodore E.,Buller, Harry R.,et al. Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients[J]. NEW ENGLAND JOURNAL OF MEDICINE,2013,368(6):513-523.
APA Cohen, Alexander T..,Spiro, Theodore E..,Buller, Harry R..,Haskell, Lloyd.,Hu, Dayi.,...&MAGELLAN Investigators.(2013).Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients.NEW ENGLAND JOURNAL OF MEDICINE,368(6),513-523.
MLA Cohen, Alexander T.,et al."Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients".NEW ENGLAND JOURNAL OF MEDICINE 368.6(2013):513-523.
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