Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program

被引：67

作者：

Yamada N. ^{[1
]}

Hirayama A. ^{[2
]}

Maeda H. ^{[3
]}

Sakagami S. ^{[4
]}

Shikata H. ^{[5
]}

Prins M.H. ^{[6
]}

Lensing A.W.A. ^{[7
]}

Kato M. ^{[8
]}

Onuma J. ^{[8
]}

Miyamoto Y. ^{[8
]}

Iekushi K. ^{[8
]}

Kajikawa M. ^{[8
]}

机构：

[1] Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Mie

[2] Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo

[3] Division of Cardiovascular, Respiratory and general surgery, Nihon University School of Medicine, Tokyo

[4] Department of Cardiology, National Hospital Organization, Kanazawa Medical Center, Kanazawa

[5] Department of Cardiovascular Surgery, Kanazawa Medical University, Ishikawa

[6] Maastricht University Medical Center, Maastricht

[7] Bayer HealthCare Pharmaceuticals, Wuppertal

[8] Bayer Yakuhin Ltd, Osaka

来源：

Thrombosis Journal | / 13卷 / 1期

基金：

日本学术振兴会;

关键词：

Deep vein thrombosis; Japan; Pulmonary embolism; Randomized trial; Rivaroxaban; Unfractionated heparin; Venous thromboembolism; Warfarin;

D O I：

10.1186/s12959-015-0035-3

中图分类号：

学科分类号：

摘要：

Background: The global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. Owing to differences in targeted anticoagulant intensities in Japan, Japanese patients were not enrolled into the global studies. Instead, a separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in Japanese patients was conducted, which compared the Japanese standard of care with a reduced dose of rivaroxaban. Methods: We conducted an open-label, randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) with activated partial thromboplastin time-adjusted intravenous unfractionated heparin (UFH) followed by warfarin (target international normalized ratio 2.0; range 1.5-2.5) in patients with acute, objectively confirmed symptomatic DVT and/or PE. Patients were assessed for the occurrence of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration and bleeding. Results: Eighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. Three patients were excluded because of serious non-compliance issues. The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, -3.4-23.8]). No major bleeding occurred during study treatment. Clinically relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban group and 1 (5.3%) patient in the UFH/warfarin group. Conclusions: The findings of this study in Japanese patients with acute DVT and/or PE suggest a similar efficacy and safety profile with rivaroxaban and control treatment, consistent with that of the worldwide EINSTEIN DVT and PE program. © 2015 Yamada et al.; licensee BioMed Central.

引用

共 24 条

[1] Silverstein M.D., Heit J.A., Mohr D.N., Petterson T.M., O'Fallon W.M., Melton L.J., Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study, Arch Intern Med, 158, pp. 585-593, (1998)
[2] Oger E., Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP study group. Groupe d'Etude de la Thrombose de Bretagne Occidentale, Thromb Haemost, 83, pp. 657-660, (2000)
[3] Cohen A.T., Agnelli G., Anderson F.A., Arcelus J.I., Bergqvist D., Brecht J.G., Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality, Thromb Haemost, 98, pp. 756-764, (2007)
[4] Kearon C., Akl E.A., Comerota A.J., Prandoni P., Bounameaux H., Goldhaber S.Z., Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines, Chest, 141, (2012)
[5] Nakamura M., Miyata T., Ozeki Y., Takayama M., Komori K., Yamada N., Current venous thromboembolism management and outcomes in Japan, Circ J, 78, pp. 708-717, (2014)
[6] Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2009), Circ J, 75, pp. 1258-1281, (2011)
[7] Simonneau G., Sors H., Charbonnier B., Page Y., Laaban J.P., Azarian R., A comparison of low-molecular-weight heparin with unfractionated heparin for acute pulmonary embolism. The THESEE study group. Tinzaparine ou Heparine standard: evaluations dans l'Embolie Pulmonaire, N Engl J Med, 337, pp. 663-669, (1997)
[8] Buller H.R., Davidson B.L., Decousus H., Gallus A., Gent M., Piovella F., Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism, N Engl J Med, 349, pp. 1695-1702, (2003)
[9] Sarich T.C., Peters G., Berkowitz S.D., Misselwitz F., Nessel C.C., Burton P., Rivaroxaban: a novel oral anticoagulant for the prevention and treatment of several thrombosis-mediated conditions, Ann N Y Acad Sci, 1291, pp. 42-55, (2013)
[10] Oral rivaroxaban for symptomatic venous thromboembolism, N Engl J Med, 363, pp. 2499-2510, (2010)

← 1 2 3 →