Pharmacokinetics and pharmacodynamics of rivaroxaban and its effect on biomarkers of hypercoagulability in patients with chronic heart failure

Journal of Heart and Lung Transplantation

Volumn 30, Issue 2, 2011, Pages 218-226

  Gheorghiade, Mihai ^a   Thyssen, An ^b   Zolynas, Robert ^c   Nadar, Venkatesh K ^d   Greenberg, Barry H ^e   Mehra, Mandeep ^f   Sun, Xiang ^c   Tian, Hong ^c   Plotnikov, Alexei N ^c   Burton, Paul ^c  

^a NORTHWESTERN UNIVERSITY   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^d Heritage Cardiology Associates   (United States)

^e UCSD MEDICAL CENTER   (United States)

^f UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

anti coagulants; cardiac output; drugs; pharmacokinetics; thrombosis

Indexed keywords

BIOLOGICAL MARKER; D DIMER; ENOXAPARIN; PLACEBO; PROTHROMBIN; RIVAROXABAN; THROMBIN ANTITHROMBIN COMPLEX;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HEART FAILURE; HUMAN; HYPERCOAGULABILITY; MALE; MULTICENTER STUDY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE;

ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ANTITHROMBIN III; BIOLOGICAL MARKERS; CHRONIC DISEASE; DOUBLE-BLIND METHOD; ENOXAPARIN; FACTOR XA; FEMALE; FIBRIN FIBRINOGEN DEGRADATION PRODUCTS; FIBRINOLYTIC AGENTS; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; MORPHOLINES; PEPTIDE FRAGMENTS; PEPTIDE HYDROLASES; PROTHROMBIN; THIOPHENES; THROMBOPHILIA;

EID: 78650933761     PISSN: 10532498     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.healun.2010.08.027     Document Type: Article

References (28)

1. G.Y. Lip, and C.R. Gibbs Does heart failure confer a hypercoagulable state? Virchow's triad revisited J Am Coll Cardiol 33 1999 1424 1426
2. R.S. Freudenberger, A.S. Hellkamp, and J.L. Halperin Risk of thromboembolism in heart failure: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Circulation 115 2007 2637 2641
3. T.M. Ng, F. Tsai, and N. Khatri Venous thromboembolism in hospitalized patients with heart failure: incidence, prognosis, and prevention Circ Heart Fail 3 2010 165 173
4. S.M. Jafri, T. Ozawa, and E. Mammen Platelet function, thrombin and fibrinolytic activity in patients with heart failure Eur Heart J 14 1993 205 212
5. S.M. Jafri, E.F. Mammen, and J. Masura Effects of warfarin on markers of hypercoagulability in patients with heart failure Am Heart J 134 1997 27 36
6. U. Alehagen, U. Dahlstrom, and T.L. Lindahl Elevated D-dimer level is an independent risk factor for cardiovascular death in out-patients with symptoms compatible with heart failure Thromb Haemost 92 2004 1250 1258
7. B. Jug, N. Vene, and B.G. Salobir Prognostic impact of haemostatic derangements in chronic heart failure Thromb Haemost 102 2009 314 320
8. N. Mackman Triggers, targets and treatments for thrombosis Nature 451 2008 914 918
9. S. Orn, J.G. Cleland, and M. Romo Recurrent infarction causes the most deaths following myocardial infarction with left ventricular dysfunction Am J Med 118 2005 752 758
10. B.F. Uretsky, K. Thygesen, and P.W. Armstrong Acute coronary findings at autopsy in heart failure patients with sudden death: results from the assessment of treatment with lisinopril and survival (ATLAS) trial Circulation 102 2000 611 616
11. K.A. Bauer, M. Homering, and S.D. Berkowitz Effects of age, weight, gender and renal function in a pooled analysis of four phase III studies of rivaroxaban for prevention of venous thromboembolism after major orthopedic surgery Blood (ASH Annual Meeting Abstracts) 2008 112
12. B.I. Eriksson, L.C. Borris, and R.J. Friedman Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty N Engl J Med 358 2008 2765 2775
13. B.I. Eriksson, A.K. Kakkar, and A.G. Turpie Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement J Bone Joint Surg Br 91 2009 636 644
14. A.K. Kakkar, B. Brenner, and O.E. Dahl Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial Lancet 372 2008 31 39
15. M.R. Lassen, W. Ageno, and L.C. Borris Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty N Engl J Med 358 2008 2776 2786
16. A.G.G. Turpie, M.R. Lassen, and B.L. Davidson Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial Lancet 373 2009 1673 1680
17. J. Mega, E. Braunwald, and S. Mohanavelu Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial Lancet 374 2009 29 38
18. D. Kubitza, M. Becka, and B. Voith Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor Clin Pharmacol Ther 78 2005 412 421
19. W. Mueck, B.I. Eriksson, and K.A. Bauer Population pharmacokinetics and pharmacodynamics of rivaroxabanan oral, direct factor Xa inhibitorin patients undergoing major orthopaedic surgery Clin Pharmacokinet 47 2008 203 216
20. D. Kubitza, M. Becka, and A. Roth Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects Curr Med Res Opin 24 2008 2757 2765
21. A. Halabi, H. Maatouk, and N. Klause Effect of renal impairment on the pharmacology of rivaroxaban (BAY 59-7939)an oral, direct Factor Xa inhibitor Blood 2006 108 Abstract 913
22. D. Kubitza, M. Becka, and M. Zuehlsdorf Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects J Clin Pharmacol 47 2007 218 226
23. J.L. Hodges, and E.L. Lehmann The efficiency of some nonparametric competitors of the ttest Ann Math Stat 27 1956 324 335
24. D. Kubitza, M. Becka, and G. Wensing Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939an oral, direct Factor Xa inhibitorafter multiple dosing in healthy male subjects Eur J Clin Pharmacol 61 2005 873 880
25. D. Kubitza, M. Becka, and W. Mueck Pharmacology of the oral, direct Factor Xa inhibitor rivaroxabaneffect of extreme age and gender Hmostaseologie 2007 Abstract A40
26. S.H. Kubo, B.A. Walter, and D.H. John Liver function abnormalities in chronic heart failure Influence of systemic hemodynamics Arch Intern Med 147 1987 1227 1230
27. S. Ljungman, J.H. Laragh, and R.J. Cody Role of the kidney in congestive heart failure Relationship of cardiac index to kidney function Drugs 39 suppl 4 1990 10 21
28. C. Weinz, T. Schwarz, and D. Kubitza Metabolism and excretion of rivaroxaban, an oral, direct Factor Xa inhibitor, in rats, dogs and humans Drug Metab Dispos 37 2009 1056 1064