Comparative effectiveness and safety of the novel oral anticoagulants: Do the pivotal clinical trials point to a new paradigm?

Journal of Thrombosis and Haemostasis

Volumn 10, Issue 12, 2012, Pages 2621-2624

  Spyropoulos, A C ^a   Goldenberg, N A ^b,c   Kessler, C M ^d   Kittelson, J ^e   Schulman, S ^f   Turpie, A G G ^f   Cutler, N R ^g   Hiatt, W R ^h   Halperin, J L ⁱ  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c JOHNS HOPKINS ALL CHILDREN S HOSPITAL   (United States)

^d GEORGETOWN UNIVERSITY   (United States)

^e Global Health and Health Disparities   (United States)

^f MCMASTER UNIVERSITY   (Canada)

^g Worldwide Clinical Trials   (United States)

^h UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

ⁱ MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; APIXABAN; DABIGATRAN; RIVAROXABAN; WARFARIN;

ANTICOAGULATION; BLEEDING; COMPARATIVE EFFECTIVENESS; DRUG COST; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; FUNDING; HEART ATRIUM FIBRILLATION; HUMAN; LETTER; PRIORITY JOURNAL;

ADMINISTRATION, ORAL; ANTICOAGULANTS; CLINICAL TRIALS AS TOPIC; HUMANS;

EID: 84871044907     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12005     Document Type: Letter

References (9)

1. Weitz JI, Eikelboom JW, Samama MM. New antithrombotic drugs: antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest 2012; 141: e120S-51S.
2. Fleming TR, Emerson SS. Evaluating rivaroxaban for nonvalvular atrial fibrillation--regulatory considerations. N Engl J Med 2011; 365: 1557-9.
3. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini J, Berkowitz SD, Fox KAA, Califf RM and the ROCKET AF Steering Committee for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation: the ROCKET AF trial. N Engl J Med 2011; 365: 883-91.
4. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51.
5. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-92.
6. Schulman S, Kearon C. The Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4.
7. Connolly SJ, Eikelboom JW, Ng J, Hirsh J, Yusuf S, Pogue J, De Caterina R, Hohnloser S, Hart RG on behalf of the ACTIVE (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events) Steering Committee and Investigators. Net clinical benefit of adding clopidogrel to aspirin therapy in patients with atrial fibrillation for whom vitamin K antagonists are unsuitable. Ann Intern Med 2011; 155: 579-86.
8. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the effective anticoagulation with factor Xa next generation in atrial fibrillation-thrombolysis in myocardial infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J 2010; 160: 635-41.
9. Goldenberg NA, Spyropoulos AC, Halperin JL, Kessler CM, Schulman S, Turpie AGG, Skene AM, Cutler NR, Hiatt WR. Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model. Blood 2011; 117: 2089-92.