Pharmacokinetics and pharmacodynamics of single doses of rivaroxaban in obese patients prior to and after bariatric surgery

British Journal of Clinical Pharmacology

Volumn 83, Issue 7, 2017, Pages 1466-1475

  Kröll, Dino ^a   Stirnimann, Guido ^a   Vogt, Andreas ^a   Lai, Desirée Lin Lee ^a   Borbély, Yves Michael ^a   Altmeier, Julia ^a   Schädelin, Sabine ^b   Candinas, Daniel ^a   Alberio, Lorenzo ^c   Nett, Philipp C ^a  

^a UNIVERSITY OF BERN   (Switzerland)

^b Clinical Trial Unit ^*  (Switzerland)

^c LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

anticoagulation; bariatric surgery; pharmacodynamics; rivaroxaban; Roux en Y gastric bypass; sleeve gastrectomy

Indexed keywords

ENOXAPARIN; PROTHROMBIN; RIVAROXABAN; THROMBIN ANTITHROMBIN COMPLEX; ANTITHROMBIN; BLOOD CLOTTING FACTOR 10A INHIBITOR; THROMBIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BARIATRIC SURGERY; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG HALF LIFE; FEMALE; HUMAN; MALE; OBESITY; PHARMACODYNAMICS; PHARMACOKINETIC PARAMETERS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; ROUX-EN-Y GASTRIC BYPASS; SINGLE DRUG DOSE; SLEEVE GASTRECTOMY; VENOUS THROMBOEMBOLISM; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; GASTRIC BYPASS SURGERY; HALF LIFE TIME; MIDDLE AGED; ORAL DRUG ADMINISTRATION; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; PROCEDURES;

ADMINISTRATION, ORAL; ADULT; ANTITHROMBINS; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR XA INHIBITORS; FEMALE; GASTRIC BYPASS; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; OBESITY; POSTOPERATIVE COMPLICATIONS; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; PROTHROMBIN; RIVAROXABAN; THROMBIN; VENOUS THROMBOEMBOLISM;

EID: 85014785976     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.13243     Document Type: Article

References (31)

1. Southan C, Sharman JL, Benson HE, Faccenda E, Pawson AJ, Alexander SP, et al. The IUPHAR/BPS guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. Nucleic Acids Res 2016; 44 (D1): D1054–D1068.
2. Alexander SPH, Fabbro D, Kelly E, Marrion N, Peters JA, Benson HE, et al. The Concise Guide to PHARMACOLOGY 2015/16: Enzymes. Br J Pharmacol 2015; 172: 6024–6109.
3. GBD 2013 Risk Factors Collaborators, Forouzanfar MH, Alexander L, Anderson HR, Bachman VF, Biryukov S, et al. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks in 188 countries, 1990–2013: a systematic analysis for the global burden of disease study 2013. Lancet 2015; 386: 2287–2323.
4. Eckel RH, Alberti KG, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet 2010; 375: 181–183.
5. Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med 2009; 122: 248–256e5.
6. Allman-Farinelli MA. Obesity and venous thrombosis: a review. Semin Thromb Hemost 2011; 37: 903–907.
7. Stein PD, Matta F, Goldman J. Obesity and pulmonary embolism: the mounting evidence of risk and the mortality paradox. Thromb Res 2011; 128: 518–523.
8. Ageno W, Becattini C, Brighton T, Selby R, Kamphuisen PW. Cardiovascular risk factors and venous thromboembolism: a meta-analysis. Circulation 2008; 117: 93–102.
9. Juhan-Vague I, Alessi MC, Mavri A, Morange PE. Plasminogen activator inhibitor-1, inflammation, obesity, insulin resistance and vascular risk. J Thromb Haemost 2003; 1: 1575–1579.
10. Escalante-Tattersfield T, Tucker O, Fajnwaks P, Szomstein S, Rosenthal RJ. Incidence of deep vein thrombosis in morbidly obese patients undergoing laparoscopic roux-en-Y gastric bypass. Surg Obes Relat Dis 2008; 4: 126–130.
11. Arnold DM, Kahn SR, Shrier I. Missed opportunities for prevention of venous thromboembolism: an evaluation of the use of thromboprophylaxis guidelines. Chest 2001; 120: 1964–1971.
12. Winegar DA, Sherif B, Pate V, DeMaria EJ. Venous thromboembolism after bariatric surgery performed by bariatric surgery Center of Excellence Participants: analysis of the bariatric outcomes longitudinal database. Surg Obes Relat Dis Surgery 2011; 7: 181–188.
13. Jamal MH, Corcelles R, Shimizu H, Kroh M, Safdie FM, Rosenthal R, et al. Thromboembolic events in bariatric surgery: a large multi-institutional referral center experience. Surg Endosc 2015; 29: 376–380.
14. American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. ASMBS updated position statement on prophylactic measures to reduce the risk of venous thromboembolism in bariatric surgery patients. Surg Obes Relat Dis 2013; 9: 493–497.
15. Finks JF, English WJ, Carlin AM, Krause KR, Share DA, Banerjee M, et al. Predicting risk for venous thromboembolism with bariatric surgery: results from the Michigan bariatric surgery collaborative. Ann Surg 2012; 255: 1100–1104.
16. Bayer Pharma AG. Xarelto® (rivaroxaban) summary of product characteristics. Available at http://wwwemaeuropaeu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108pdf. 2013 (last accessed 2 August 2016).
17. Kubitza D, Becka M, Voith B, Zuehlsdorf M, Wensing G. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther 2005; 78: 412–421.
18. Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673–1680.
19. Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765–2775.
20. Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776–2786.
21. Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372: 31–39.
22. Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res 2013; 471: 3358–3366.
23. Mueck W, Eriksson BI, Bauer KA, Borris L, Dahl OE, Fisher WD, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban – an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery. Clin Pharmacokinet 2008; 47: 203–216.
24. Duffull SB. Is the ideal anticoagulant a myth? Expert Rev Clin Pharmacol 2012; 5: 231–236.
25. Asmis LM, Alberio L, Angelillo-Scherrer A, Korte W, Mendez A, Reber G, et al. Rivaroxaban: quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories. Thromb Res 2012; 129: 492–498.
26. Zurcher M, Sulzer I, Barizzi G, Lammle B, Alberio L. Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature. Thromb Haemost 2008; 99: 416–426.
27. Chilver-Stainer L, Lammle B, Alberio L. Titre of anti-heparin/PF4-antibodies and extent of in vivo activation of the coagulation and fibrinolytic systems. Thromb Haemost 2004; 91: 276–282.
28. Mueck W, Stampfuss J, Kubitza D, Becka M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet 2014; 53: 1–16.
29. Mueck W, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, et al. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 2008; 100: 453–461.
30. Chandler WL, Velan T. Estimating the rate of thrombin and fibrin generation in vivo during cardiopulmonary bypass. Blood 2003; 101: 4355–4362.
31. Kubitza D, Becka M, Zuehlsdorf M, 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 2007; 47: 218–226.