References
- Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. The pharmacology and management of the vitamin K antiagonists; ACCP evidence based clinical practice guidelines eight edition. Chest133, 160S–198S (2008).
- Weitz J. New oral anticoagulants in development. Thromb. Haemost.103, 62–70 (2010).
- Budnitz DS, Shehab N, Kegler SR, Richards CL. Medication use leading to emergency department visits for adverse drug events in older adults. Ann. Intern. Med.147, 755–765 (2007).
- Verheugt FW. Novel oral anticoagulants to prevent stroke in atrial fibrillation. Nat. Rev. Cardiol.7, 195–154 (2010).
- Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb. Haemost.103, 572–585 (2010).
- Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thrombophylaxis after knee replacement. N. Engl. J. Med.361, 594–604 (2009).
- Lassen MR, Raskob G, Gallus A. Pineo G, Chen D, Portman RJ. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomized double blind trial. Lancet375(9717), 807–815 (2010).
- Mohapatra R, Tran M, Gore JM, Spencer FA. A review of the oral direct thrombin inhibitor ximelagatran: not yet the end of the warfarin era. Am. Heart. J.150, 19–26 (2005).
- Eriksson BI, Quinlan DJ, Weitz JI. Competitive pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors development. Clin. Pharmacokinet.48, 1–22 (2009).
- Hauel NH, Nar H, Priepke H et al. Structure-based design of novel potent nonpeptide thrombin inhibitors. J. Med. Chem.45, 1757–1766 (2002).
- Stangier J, Rathgen K, Stahle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br. J. Clin. Pharmacol.64(3), 292–303 (2007).
- Stangier J, Eriksson BI, Dahl OE et al. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J. Clin. Pharmacol.45, 555–563 (2005).
- Stangier J, Stahle H, Rathgen K, Fuhr R. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin. Pharmacokinet.47(1), 47–59 (2008).
- Eriksson BI, Dahl OE, Ahnefelt L et al. Dose escalating safety study of a new oral direct thrombin inhibitor, dabigatran etexilate, in patients undergoing total hip replacement: BISTRO I. J. Thromb. Haemost.2, 1573–1580 (2004).
- Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran in humans. Drug Metab. Dispos.36(2), 386–399 (2008).
- Stangier J, Rathgen K, Stahle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate. Clin. Pharmacokinet.49(4), 259–268 (2010).
- Stangier J, Stahle H, Rathgen K, Roth W, Shakeri-Nejad K. Pharmacokinetics and Pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, are not affected by moderate hepatic impairment. J. Clin. Pharmacol.48, 1411–1419 (2008).
- Eriksson BI, Dahl OE, Büll HR et al. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. J. Thromb. Haemost.3, 103–111 (2005).
- Geerts WH, Bergquist D, Pineo GF et al. Prevention of venous thromboembolism. American College of Chest Physisicans Evidence-Based Clinical Practice Guidelines (8th Edition). Chest133, 381S–453S (2008).
- Eriksson BI, Dahl OE, Rosencher N et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J. Thromb. Haemost.5, 2178–2185 (2007).
- Eriksson BI, Dahl OE, Rosencher N et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomized, double-blind, non-inferiority trial. Lancet370, 949–956 (2007).
- Ginsberg JS, Davidson BL, Comp PC et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J. Athroplasty24, 1–9 (2009).
- Schulman S. Kearon C. Kakkar A et.al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N. Engl. J. Med.361, 2342–2352 (2009).
- Rose AJ, Ozonoff A, Henault LE, Hylek EM. Warfarin for atrial fibrillation in community based practice. J. Thromb. Haemost.6, 1647–1654 (2008).
- Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med.361, 1139–1151 (2009).
- Fiessinger JN, Huisman MC, Davidson BL. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: a randomized trial. J. Am. Med. Assoc.349, 1713–1721 (2003).
- Ezekowitz MD, Reilly PA, Nehmiz G et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO study). Am. J. Cardiol.100, 1419–1426 (2007).
Websites
- Evaluation of the efficacy and safety of rivaroxaban (BAY59–7939) for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation http://clinicaltrials.gov/ct2/show/NCT00494871 (Accessed 31 March 2010)
- Once-daily oral direct Factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study http://clinicaltrials.gov/ct2/show/NCT00439725 (Accessed 31 March 2010)
- Oral direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism with or without symptomatic deep-vein thrombosis: Einstein-PE evaluation http://clinicaltrials.gov/ct2/show/NCT00439777 (Accessed 31 March 2010)
- A prospective, randomized, double-blind, double-dummy, parallel-group, multicenter, event-driven, non-inferiority study comparing the efficacy and safety of once-daily oral rivaroxaban (BAY 59–7939) with adjusted-dose oral warfarin for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation http://clinicaltrials.gov/ct2/show/NCT00403767?term=NCT00403767&rank=1 (Accessed 28 June 2010)
- Study of apixaban for the prevention of thrombosis-related events in patients with acute medical illness (ADOPT) http://clinicaltrials.gov/ct2/show/NCT00457002 (Accessed 31March 2010).
- Apixaban versus acetylsalicylic acid (ASA) to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist Treatment: a randomized double blind trial http://clinicaltrials.gov/ct2/show/NCT00496769 (Accessed 31 March 2010)
- A Phase III, active (warfarin) controlled, randomized, double-blind, parallel arm study to evaluate efficacy and safety of apixaban in preventing stroke and systemic embolism in subjects with nonvalvular atrial fibrillation http://clinicaltrials.gov/ct2/show/NCT00412984 (Accessed 31March 2010)
- A safety and efficacy trial evaluating the use of apixaban in the treatment of symptomatic deep vein thrombosis and pulmonary embolism http://clinicaltrials.gov/ct2/show/NCT00643201?term=apixaban&rank=3 (Accessed 28 May 2010)
- A safety and efficacy trial evaluating the use of apixaban for the extended treatment of deep vein thrombosis and pulmonary embolism http://clinicaltrials.gov/ct2/show/NCT00633893 (Accessed on 31 March (2010)
- European Medicines Agency (EMEA): European Public Assessment report – Pradaxa. EMEA website [online] www.emea.europa.eu/humandocs/Humans/EPAR/pradaxa/pradaxa.htm (Accessed 24 May 2010)
- A randomised, parallel-group, double-blind, placebo controlled study to investigate the efficacy and safety of bibr 1048 in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery http://clinicaltrials.gov/ct2/show/NCT00246025?term=NCT00246025&rank=1 (Accessed on 5 May 2010)
- A Phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of orally administered dabigatran etexilate capsules compared to subcutaneous 40 mg enoxaparin once daily for 28–35 days, in prevention of venous thromboembolism in patients with primary elective total hip arthroplasty surgery (RE-NOVATE II) http://clinicaltrials.gov/ct2/show/NCT00657150?term=RE-NOVATE+II&rank=1 (Accessed on 5 May 2010)
- Observational cohort study to evaluate the safety and efficacy of pradaxa (dabigatran etexilate) for the prevention of venous thromboembolism in patients undergoing elective total hip replacement surgery or total knee replacement surgery in a routine clinical setting http://clinicaltrials.gov/ct2/show/NCT00846807?term=NCT00846807&rank=1 (Accessed on 5 May 2010)
- Observational cohort study to evaluate safety and efficacy of pradaxa (dabigatran etexilate) in patients with moderate renal impairment (creatinine clearance 30–50 ml/min) undergoing elective total hip replacement surgery or total knee replacement surgery http://clinicaltrials.gov/ct2/show/NCT00847301?term=NCT00847301&rank=1 (Accessed on 5 May 2010)
- Twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long-term prevention of recurrent symptomatic proximal venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism http://clinicaltrials.gov/ct2/show/NCT00558259?term=dabigatran&rank=6 (Accessed 19 May 2010)
- A Phase III, randomised, double blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared with warfarin (INR 2.0–3.0) for 6 month treatment of acute symptomatic venous thromboembolism, following initial treatment (5–10 days) with a parenteral anticoagulant approved for this indication http://clinicaltrials.gov/ct2/show/NCT00680186?term=dabigatran&rank=8 (Accessed on 19 May 2010)
- Safety and tolerability of dabigatran etexilate in adolescents http://clinicaltrials.gov/ct2/show/NCT00844415?term=dabigatran&rank=11 (Accessed 19 May 2010)
- Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years http://clinicaltrials.gov/ct2/show/NCT01083732?term=dabigatran&rank=12(Accessed 19 May 2010)
- A randomised, multicenter, double-blind, active controlled study to investigate the efficacy and safety of dabigatran etexilate, 150 mg b.i.d administered orally (capsules) for 18 months, compared with warfarin tablets p.r.n. (target INR) for the secondary prevention of venous thromboembolism http://clinicaltrials.gov/ct2/show/NCT00329238?term=dabigatran&rank=17 (Accessed 19 May 2010)