메뉴 건너뛰기




Volumn 28, Issue 4, 2013, Pages 321-331

Confirmation of model-based dose selection for a Japanese phase III study of rivaroxaban in non-valvular atrial fibrillation patients

Author keywords

Anticoagulants; Japanese phase III; PK PD model; Population PK; Rivaroxaban

Indexed keywords

ANTICOAGULANT AGENT; BENZODIAZEPINE DERIVATIVE; CYTOCHROME P450 3A4; DIURETIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PROTEIN INHIBITOR; RIVAROXABAN; WARFARIN;

EID: 84878663745     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.2133/dmpk.DMPK-12-RG-109     Document Type: Article
Times cited : (47)

References (38)
  • 1
    • 27744477732 scopus 로고    scopus 로고
    • Rapid increase in estimated number of persons with atrial fibrillation in Japan: An analysis from national surveys on cardiovascular diseases in 1980, 1990 and 2000
    • Ohsawa, M., Okayama, A., Sakata, K., Kato, K., Itai, K., Onoda, T. and Ueshima, H.: Rapid increase in estimated number of persons with atrial fibrillation in Japan: an analysis from national surveys on cardiovascular diseases in 1980, 1990 and 2000. J. Epidemiol., 15: 194-196 (2005).
    • (2005) J. Epidemiol. , vol.15 , pp. 194-196
    • Ohsawa, M.1    Okayama, A.2    Sakata, K.3    Kato, K.4    Itai, K.5    Onoda, T.6    Ueshima, H.7
  • 3
    • 34548455445 scopus 로고    scopus 로고
    • Independent predictors of stroke in patients with atrial fibrillation: A systematic review
    • Stroke Risk in Atrial Fibrillation Working Group
    • Stroke Risk in Atrial Fibrillation Working Group: Independent predictors of stroke in patients with atrial fibrillation: a systematic review. Neurology, 69: 546-554 (2007).
    • (2007) Neurology , vol.69 , pp. 546-554
  • 4
    • 45949095568 scopus 로고    scopus 로고
    • American College of Chest Physicians. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians evidence-based clinical practice guidelines
    • 8th Edition
    • Singer, D. E., Albers, G. W., Dalen, J. E., Fang, M. C., Go, A. S., Halperin, J. L., Lip, G. Y. and Manning, W. J.: American College of Chest Physicians. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest, 133: 546S-592S (2008).
    • (2008) Chest , vol.133
    • Singer, D.E.1    Albers, G.W.2    Dalen, J.E.3    Fang, M.C.4    Go, A.S.5    Halperin, J.L.6    Lip, G.Y.7    Manning, W.J.8
  • 5
    • 34347394385 scopus 로고    scopus 로고
    • Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation
    • Hart, R. G., Pearce, L. A. and Aguilar, M. I.: Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann. Intern. Med., 146: 857-867 (2007).
    • (2007) Ann. Intern. Med. , vol.146 , pp. 857-867
    • Hart, R.G.1    Pearce, L.A.2    Aguilar, M.I.3
  • 7
    • 79953038399 scopus 로고    scopus 로고
    • 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines
    • Fuster, V., Ryden, L. E., Cannom, D. S., Crijns, H. J., Curtis, A. B., Ellenbogen, K. A., Halperin, J. L., Kay, G. N., Le Huezey, J. Y., Lowe, J. E., Olsson, S. B., Prystowsky, E. N., Tamargo, J. L. and Wann, L. S.: 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation, 123: e269-e367 (2011).
    • (2011) Circulation , vol.123
    • Fuster, V.1    Ryden, L.E.2    Cannom, D.S.3    Crijns, H.J.4    Curtis, A.B.5    Ellenbogen, K.A.6    Halperin, J.L.7    Kay, G.N.8    le Huezey, J.Y.9    Lowe, J.E.10    Olsson, S.B.11    Prystowsky, E.N.12    Tamargo, J.L.13    Wann, L.S.14
  • 8
    • 78349242121 scopus 로고    scopus 로고
    • Guidelines for pharmacotherapy of atrial fibrillation (JCS 2008): Digest version
    • Japanese Circulation Society Joint Working Group
    • Japanese Circulation Society Joint Working Group: Guidelines for pharmacotherapy of atrial fibrillation (JCS 2008): digest version. Circ. J., 74: 2479-2500 (2010).
    • (2010) Circ. J. , vol.74 , pp. 2479-2500
  • 9
    • 84866904806 scopus 로고    scopus 로고
    • Guidelines for management of anticoagulant and antiplatelet therapy in cardiovascular disease (JCS 2009)
    • Japanese Circulation Society Joint Working Group
    • Japanese Circulation Society Joint Working Group: Guidelines for management of anticoagulant and antiplatelet therapy in cardiovascular disease (JCS 2009). Nihon Rinsho, 69 Suppl. 9: 567-571 (2011).
    • (2011) Nihon Rinsho , vol.9 , Issue.69 SUPPL. , pp. 567-571
  • 10
    • 45949103309 scopus 로고    scopus 로고
    • Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines
    • 8th Edition
    • Ansell, J., Hirsh, J., Hylek, E., Jacobson, A., Crowther, M. and Palareti, G.: Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest, 133:160S-198S (2008).
    • (2008) Chest , vol.133
    • Ansell, J.1    Hirsh, J.2    Hylek, E.3    Jacobson, A.4    Crowther, M.5    Palareti, G.6
  • 11
    • 68349148473 scopus 로고    scopus 로고
    • The need for new oral anticoagulants in clinical practice
    • Hylek, E. M.: The need for new oral anticoagulants in clinical practice. J. Cardiovasc. Med. (Hagerstown), 10: 605-609 (2009).
    • (2009) J. Cardiovasc. Med. (Hagerstown) , vol.10 , pp. 605-609
    • Hylek, E.M.1
  • 12
    • 77957932391 scopus 로고    scopus 로고
    • 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)
    • Ruff, C. T., Giugliano, R. P., Antman, E. M., Crugnale, S. E., Bocanegra, T., Mercuri, M., Hanyok, J., Patel, I., Shi, M., Salazar, D., McCabe, C. H. and 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., 160: 635-641 (2010).
    • (2010) Am. Heart J. , vol.160 , pp. 635-641
    • Ruff, C.T.1    Giugliano, R.P.2    Antman, E.M.3    Crugnale, S.E.4    Bocanegra, T.5    Mercuri, M.6    Hanyok, J.7    Patel, I.8    Shi, M.9    Salazar, D.10    McCabe, C.H.11    Braunwald, E.12
  • 18
    • 25844525489 scopus 로고    scopus 로고
    • Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct Factor Xa inhibitor
    • Kubitza, D., Becka, M., Voith, B., Zuehlsdorf, M. and Wensing, G.: Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct Factor Xa inhibitor. Clin. Pharmacol. Ther., 78: 412-421 (2005).
    • (2005) Clin. Pharmacol. Ther. , vol.78 , pp. 412-421
    • Kubitza, D.1    Becka, M.2    Voith, B.3    Zuehlsdorf, M.4    Wensing, G.5
  • 19
    • 29144518504 scopus 로고    scopus 로고
    • Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939-an oral, direct Factor Xa inhibitor-after multiple dosing in healthy male subjects
    • Kubitza, D., Becka, M., Wensing, G., Voith, B. and Zuehlsdorf, M.: Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939-an oral, direct Factor Xa inhibitor-after multiple dosing in healthy male subjects. Eur. J. Clin. Pharmacol., 61: 873-880 (2005).
    • (2005) Eur. J. Clin. Pharmacol. , vol.61 , pp. 873-880
    • Kubitza, D.1    Becka, M.2    Wensing, G.3    Voith, B.4    Zuehlsdorf, M.5
  • 21
    • 51349095537 scopus 로고    scopus 로고
    • Population pharmacokinetics and pharmacodynamics of once-and twicedaily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement
    • Mueck, W., Borris, L. C., Dahl, O. E., Haas, S., Huisman, M. V., Kakkar, A. K., Kälebo, P., Muelhofer, E., Misselwitz, F. and Eriksson, B. I.: Population pharmacokinetics and pharmacodynamics of once-and twicedaily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb. Haemost., 100: 453-461 (2008).
    • (2008) Thromb. Haemost. , vol.100 , pp. 453-461
    • Mueck, W.1    Borris, L.C.2    Dahl, O.E.3    Haas, S.4    Huisman, M.V.5    Kakkar, A.K.6    Kälebo, P.7    Muelhofer, E.8    Misselwitz, F.9    Eriksson, B.I.10
  • 24
    • 34250166525 scopus 로고    scopus 로고
    • Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct Factor Xa inhibitor-in healthy subjects
    • Mueck, W., Becka, M., Kubitza, D., Voith, B. and Zuehlsdorf, M.: Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct Factor Xa inhibitor-in healthy subjects. Int. J. Clin. Pharmacol. Ther., 45: 335-344 (2007).
    • (2007) Int. J. Clin. Pharmacol. Ther. , vol.45 , pp. 335-344
    • Mueck, W.1    Becka, M.2    Kubitza, D.3    Voith, B.4    Zuehlsdorf, M.5
  • 25
    • 80052485992 scopus 로고    scopus 로고
    • Rivaroxaban: Population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention
    • Mueck, W., Lensing, A. W., Agnelli, G., Decousus, H., Prandoni, P. and Misselwitz, F.: Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin. Pharmacokinet., 50: 675-686 (2011).
    • (2011) Clin. Pharmacokinet. , vol.50 , pp. 675-686
    • Mueck, W.1    Lensing, A.W.2    Agnelli, G.3    Decousus, H.4    Prandoni, P.5    Misselwitz, F.6
  • 26
    • 84874615039 scopus 로고    scopus 로고
    • Model-based dose selection for phase III rivaroxaban study in Japanese patients with non-valvular atrial fibrillation
    • Tanigawa, T., Kaneko, M., Hashizume, K., Kajikawa, M., Ueda, H., Tajiri, M. and Mueck, W.: Model-based dose selection for phase III rivaroxaban study in Japanese patients with non-valvular atrial fibrillation. Drug Metab. Pharmacokinet., 28: 59-70 (2012).
    • (2012) Drug Metab. Pharmacokinet. , vol.28 , pp. 59-70
    • Tanigawa, T.1    Kaneko, M.2    Hashizume, K.3    Kajikawa, M.4    Ueda, H.5    Tajiri, M.6    Mueck, W.7
  • 27
    • 55549139511 scopus 로고    scopus 로고
    • Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects
    • Kubitza, D., Becka, M., Roth, A. and Mueck, W.: Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr. Med. Res. Opin., 24: 2757-2765 (2008).
    • (2008) Curr. Med. Res. Opin. , vol.24 , pp. 2757-2765
    • Kubitza, D.1    Becka, M.2    Roth, A.3    Mueck, W.4
  • 28
    • 33846448135 scopus 로고    scopus 로고
    • Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects
    • Kubitza, D., Becka, M., Zuehlsdorf, M. and Mueck, W.: Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J. Clin. Pharmacol., 47: 218-226 (2007).
    • (2007) J. Clin. Pharmacol. , vol.47 , pp. 218-226
    • Kubitza, D.1    Becka, M.2    Zuehlsdorf, M.3    Mueck, W.4
  • 29
    • 79957855883 scopus 로고    scopus 로고
    • Present status of anticoagulation treatment in Japanese patients with atrial fibrillation
    • Atarashi, H., Inoue, H., Okumura, K., Yamashita, T., Kumagai, N. and Origasa, H.: Present status of anticoagulation treatment in Japanese patients with atrial fibrillation. Circ. J., 75: 1328-1333 (2011).
    • (2011) Circ. J. , vol.75 , pp. 1328-1333
    • Atarashi, H.1    Inoue, H.2    Okumura, K.3    Yamashita, T.4    Kumagai, N.5    Origasa, H.6
  • 30
    • 49849103069 scopus 로고    scopus 로고
    • Determination of rivaroxaban-a novel, oral, direct Factor Xa inhibitor-in human plasma by high-performance liquid chromatography-tandem mass spectrometry
    • Rohde, G.: Determination of rivaroxaban-a novel, oral, direct Factor Xa inhibitor-in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 872: 43-50 (2008).
    • (2008) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. , vol.872 , pp. 43-50
    • Rohde, G.1
  • 34
    • 33744839368 scopus 로고
    • A formula to estimate the approximate surface area if height and weight are known
    • DuBois, D. and DuBois, E. F.: A formula to estimate the approximate surface area if height and weight are known. Arch. Intern. Med., 17: 863-871 (1916).
    • (1916) Arch. Intern. Med. , vol.17 , pp. 863-871
    • DuBois, D.1    DuBois, E.F.2
  • 36
    • 0016916438 scopus 로고
    • Prediction of creatinine clearance from serum creatinine
    • Cockcroft, D. W. and Gault, M. H.: Prediction of creatinine clearance from serum creatinine. Nephron, 16: 31-41 (1976).
    • (1976) Nephron , vol.16 , pp. 31-41
    • Cockcroft, D.W.1    Gault, M.H.2
  • 37
  • 38
    • 67650932119 scopus 로고    scopus 로고
    • Safety, pharmacokinetics and pharmacodynamics of single/multiple doses of the oral, direct Factor Xa inhibitor rivaroxaban in healthy Chinese subjects
    • Zhao, X., Sun, P., Zhou, Y., Liu, Y., Zhang, H., Mueck, W., Kubitza, D., Bauer, R. J., Zhang, H. and Cui, Y.: Safety, pharmacokinetics and pharmacodynamics of single/multiple doses of the oral, direct Factor Xa inhibitor rivaroxaban in healthy Chinese subjects. Br. J. Clin. Pharmacol., 68: 77-88 (2009).
    • (2009) Br. J. Clin. Pharmacol. , vol.68 , pp. 77-88
    • Zhao, X.1    Sun, P.2    Zhou, Y.3    Liu, Y.4    Zhang, H.5    Mueck, W.6    Kubitza, D.7    Bauer, R.J.8    Zhang, H.9    Cui, Y.10


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.