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