Edoxaban for the long‐term treatment of venous thromboembolism: rationale and design of the Hokusai‐venous thromboembolism study – methodological implications for clinical trials

Journal of Thrombosis and Haemostasis - Tập 11 - Trang 1287-1294 - 2013
G. Raskob1, H. Büller2, M. Prins3, A. Segers4, M. Shi5, L. Schwocho5, R. van Kranen6, M. Mercuri5
1University of Oklahoma Health Sciences Centre, Oklahoma City, OK, USA
2Academic Medical Center, Amsterdam, The Netherlands
3Maastricht University Medical Center, Maastricht, The Netherlands
4International Clinical Trial Organization and Management Academic Research Organization, Amsterdam, the Netherlands
5Daiichi Sankyo Pharma Development, Edison, NJ, USA
6Daiichi Sankyo Development Ltd, Gerrards Cross, UK

Tài liệu tham khảo

Kearon, 2012, 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, e419S, 10.1378/chest.11-2301 2006, Prevention and treatment of venous thromboembolism. International Consensus Statement (guidelines according to scientific evidence), Int Angiol, 25, 101 Ageno, 2012, Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence‐Based Clinical Practice Guidelines, Chest, 141, e44S, 10.1378/chest.11-2292 Connolly, 2008, Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range, Circulation, 118, 2029, 10.1161/CIRCULATIONAHA.107.750000 Weitz, 2012, New antithrombotic drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence‐Based Clinical Practice Guidelines, Chest, 141, e120S, 10.1378/chest.11-2294 Ogata, 2010, Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers, J Clin Pharmacol, 50, 743, 10.1177/0091270009351883 Matsushima, 2011, Absolute bioavailability of edoxaban in healthy subjects, AAPS J, 13 Raskob, 2010, Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomized double‐blind dose–response study, Thromb Haemost, 104, 642, 10.1160/TH10-02-0142 Fuji, 2010, A dose‐ranging study evaluating the oral factor Xa inhibitor edoxaban for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty, J Thromb Haemost, 8, 2458, 10.1111/j.1538-7836.2010.04021.x Fuji, 2010, Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J‐V trial, Blood, 116, 3320, 10.1182/blood.V116.21.3320.3320 Fuji, 2010, Edoxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E‐3 trial, Pathophysiol Haemost Thromb, 37, A20 2011 Weitz, 2010, Randomised, parallel‐group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation, Thromb Haemost, 104, 633, 10.1160/TH10-01-0066 Salazar, 2012, Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation, Thromb Haemost, 107, 925, 10.1160/TH11-08-0566 Büller, 2003, Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism, N Engl J Med, 349, 1695, 10.1056/NEJMoa035451 Buller, 2007, Idraparinux versus standard therapy for venous thromboembolic disease, N Engl J Med, 357, 1094, 10.1056/NEJMoa064247 Buller, 2007, Extended prophylaxis of venous thromboembolism with idraparinux, N Engl J Med, 357, 1105, 10.1056/NEJMoa067703 Rosendaal, 1993, A method to determine the optimal intensity of oral anticoagulant therapy, Thromb Haemost, 69, 236, 10.1055/s-0038-1651587 Schulman, 2009, Dabigatran versus warfarin in the treatment of acute venous thromboembolism, N Engl J Med, 361, 2342, 10.1056/NEJMoa0906598 Schulman, 2013, Extended use of dabigatran, warfarin, or placebo in venous thromboembolism, N Engl J Med, 368, 709, 10.1056/NEJMoa1113697 Büller, 2012, Enoxaparin followed by once‐weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double‐blind, double‐dummy, non‐inferiority trial, Lancet, 379, 123, 10.1016/S0140-6736(11)61505-5 Bauersachs, 2010, Oral rivaroxaban for symptomatic venous thromboembolism, N Engl J Med, 363, 2499, 10.1056/NEJMoa1007903 Büller, 2012, Oral rivaroxaban for the treatment of symptomatic pulmonary embolism, N Engl J Med, 366, 1287, 10.1056/NEJMoa1113572 Büller, 2008, Double‐blind studies are not always optimum for evaluation of a novel therapy: the case of new anticoagulants, J Thromb Haemost, 6, 227, 10.1111/j.1538-7836.2007.02848.x Sackett, 1979, Bias in analytic research, J Chronic Dis, 32, 51, 10.1016/0021-9681(79)90012-2 Hull, 1982, Different intensities of oral anticoagulant therapy in the treatment of proximal‐vein thrombosis, N Engl J Med, 307, 1676, 10.1056/NEJM198212303072704 Deitelzweig, 2010, Warfarin therapy in patients with venous thromboembolism: patterns of use and predictors of clinical outcomes, Adv Ther, 27, 623, 10.1007/s12325-010-0056-z Willey, 2004, Management patterns and outcomes of patients with venous thromboembolism in the usual community practice setting, Clin Ther, 26, 1149, 10.1016/S0149-2918(04)90187-7 Sackett, 1980, The competing objectives of randomized trials, N Engl J Med, 303, 1059, 10.1056/NEJM198010303031812