Rivaroxaban: Practical considerations for ensuring safety and efficacy

Pharmacotherapy

Volumn 33, Issue 11, 2013, Pages 1223-1245

  Smythe, Maureen A ^a,b   Fanikos, John ^c   Gulseth, Michael P ^d   Wittkowsky, Ann K ^e   Spinler, Sarah A ^f   Dager, William E ^g   Nutescu, Edith A ^h  

^a WAYNE STATE UNIVERSITY   (United States)

^b BEAUMONT HOSPITAL   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d UNIVERSITY OF SOUTH DAKOTA   (United States)

^e UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

^f UNIVERSITY OF THE SCIENCES   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

anticoagulation; atrial fibrillation; direct factor Xa inhibitor; drug safety; rivaroxaban; venous thromboembolism prevention

Indexed keywords

ANTIDOTE; RIVAROXABAN; ANTICOAGULANT AGENT; MORPHOLINE DERIVATIVE; THIOPHENE DERIVATIVE;

ACUTE CORONARY SYNDROME; ANESTHESIA INDUCTION; ANTICOAGULATION; BLEEDING; BODY WEIGHT; BRAIN ISCHEMIA; CATHETER ABLATION; CEREBROVASCULAR ACCIDENT; CLINICAL HANDOVER; CLINICAL PROTOCOL; DEEP VEIN THROMBOSIS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG INDICATION; DRUG MONITORING; DRUG SAFETY; EVIDENCE BASED MEDICINE; HEART ATRIUM FIBRILLATION; HOSPITAL POLICY; HUMAN; INVASIVE PROCEDURE; KIDNEY DISEASE; NONHUMAN; OUTCOME ASSESSMENT; PARTIAL THROMBOPLASTIN TIME; PATIENT EDUCATION; PHASE 3 CLINICAL TRIAL (TOPIC); PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK ASSESSMENT; TREATMENT PLANNING; UNNECESSARY PROCEDURE; VENOUS THROMBOEMBOLISM; CHEMICALLY INDUCED; DRUG EFFECTS; HEMORRHAGE; ORAL DRUG ADMINISTRATION; PHYSIOLOGY; PROCEDURES; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANTICOAGULANTS; BODY WEIGHT; CLINICAL TRIALS, PHASE III AS TOPIC; HEMORRHAGE; HUMANS; MORPHOLINES; THIOPHENES; TREATMENT OUTCOME;

EID: 84886597864     PISSN: 02770008     EISSN: 18759114     Source Type: Journal    
DOI: 10.1002/phar.1289     Document Type: Review

References (99)

1. Spencer F, Emery C, Lessard D, et al. The Worcester Venous Thromboembolism study: a population-based study of the clinical epidemiology of venous thromboembolism. J Gen Intern Med 2006; 2: 722-7.
2. Nutescu E,. Characteristics of novel anticoagulants and potential economic implications. Am J Manag Care 2011; 17: 527-32.
3. Weitz J,. New oral anticoagulants in development. Thromb Haemost 2010; 103: 62-70.
4. Eriksson B, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765-75.
5. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-86.
6. Turpie A, Lassen MR, Davidson BL, et al. RECORD4 investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673-80.
7. Kakkar AK, Brenner B, Dahl OE, 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 (9632): 31-9.
8. Cohen AT, Spiro TE, Biller HR, et al. Extended duration rivaroaxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis 2011; 31: 407-16.
9. EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510.
10. EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97.
11. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91.
12. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med 2012; 366: 9-19.
13. Bounameaux H, Reber G,. New oral antithrombotics: a need for laboratory monitoring. J Thromb Haemost 2010; 8: 627-30.
14. Harenberg J, Marx S, Erdle S, Kramer R,. Determination of the anticoagulant effects of new oral anticoagulants: an unmet need. Expert Rev Hematol 2012; 5: 107-13.
15. 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: 412-21.
16. Kubitza D, Becka M, Wensing G, Voith B, 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 2005; 61: 873-80.
17. Hillarp A, Baghaei F, Fagerberg Blixter I, et al. Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays. J Thromb Haemost 2011; 9: 133-9.
18. Harenberg J, Erdle S, Marx S, Kramer R,. Determination of rivaroxaban in human plasma samples. Semin Thromb Hemost 2012; 38: 178-84.
19. Samama MM, Martinoli JL, LeFlem L, et al. Assessment of laboratory assays to measure rivaroxaban-an oral, direct factor Xa inhibitor. Thromb Haemost 2010; 103: 815-25.
20. Kamal AH, Tefferi A, Pruthi RK,. How to interpret and pursue an abnormal prothrombin time, activated partial thromboplastin time, and bleeding time in adults. Mayo Clin Proc 2007; 82: 864-73.
21. U.S. Food and Drug Administration. Briefing information for the cardiovascular and renal drugs advisory committee (CRDAC), May 23, 2012, meeting. Available from http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeeting Materials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM304755.pdf. Accessed January 22, 2013.
22. Mueck W, Lensing AW, Agnelli G, Decousus H, Prandoni P, 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 2011; 50: 675-86.
23. Haas S,. Facts and artefacts of coagulation assays for factor Xa inhibitors. Thromb Haemost 2010; 103: 686-8.
24. Palladino M, Thomson L, Swift B, Merli GJ,. Implementing the new oral anticoagulants into the hospital formulary. Am J Hematol 2012; 87 (Suppl 1): S127-32.
25. Merriman E, Kaplan Z, Butler J, Malan E, Gan E, Tran H,. Rivaroxaban and false positive lupus anticoagulant testing. Thromb Haemost 2011; 105: 385-6.
26. Freyburger G, Macouillard G, Labrouche S, Sztark F,. Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 2011; 127: 457-65.
27. Barrett YC, Wang Z, Frost C, Shenker A,. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010; 104: 1263-71.
28. Mani H, Hesse C, Stratmann G, Lindhoff-Last E,. Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time. Thromb Haemost 2011; 106: 156-64.
29. U.S. Food and Drug Administration. FDA draft briefing document for the cardiovascular and renal drugs advisory committee (CRDAC), meeting, September 8, 2011. Available from http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM270796.pdf. Accessed January 22, 2013.
30. Lindhoff-Last E, Samama MM, Ortel TL, Weitz JI, Spiro TE,. Assays for measuring rivaroxaban: their suitability and limitations. Ther Drug Monit 2010; 32: 673-9.
31. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban-an oral, direct factor Xa inhibitor-in patients undergoing major orthopaedic surgery. Clin Pharmacokinet 2008; 47: 203-16.
32. Bauer KA,. Reversal of antithrombotic agents. Am J Hematol 2012; 87 (Suppl 1): S119-26.
33. Harenberg J, Marx S, Kramer R, Giese C, Weiss C,. Determination of an international sensitivity index of thromboplastin reagents using a WHO thromboplastin as calibrator for plasma spiked with rivaroxaban. Blood Coagul Fibrinolysis 2011; 22: 637-41.
34. Harenberg J, Kramer R, Giese C, Marx S, Weiss C, Wehling M,. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability. J Thromb Thrombolysis 2011; 32: 267-71.
35. Samama MM, Amiral J, Guinet C, Perzborn E, Depasse F,. An optimised, rapid chromogenic assay, specific for measuring direct factor Xa inhibitors (rivaroxaban) in plasma. Thromb Haemost 2010; 104: 1078-9.
36. Perzborn E, Harwardt M, Samama MM,. Assessment of factor Xa chromogenic assays for measuring the pharmacodynamics of rivaroxaban-an oral, direct factor Xa inhibitor. J Thromb Haemost 2007; 5 (Suppl 2): PP-MO-185.
37. Samama MM, Contant G, Spiro TE, et al. Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls. Thromb Haemost 2012; 107: 379-87.
38. Harenberg J, Marx S, Weiss C, Kramer R, Samama M, Schulman S,. Report of the Subcommittee of Control of Anticoagulation on the determination of the anticoagulant effects of rivaroxaban. J Thromb Haemost 2012; 10: 1433-6.
39. Harder S, Parisius J, Picard-Willems B,. Monitoring direct FXa-inhibitors and fondaparinux by Prothrombinase-induced Clotting Time (PiCT): relation to FXa-activity and influence of assay modifications. Thromb Res 2008; 123: 396-403.
40. Bayer Canada. Xarelto Product Monograph. Available from http://www.bayer.ca/files/XARELTO-PM-ENG-18JUL2012-154961.pdf ?#. Accessed January 22, 2013.
41. Wittkowsky AK,. Novel oral anticoagulants and their role in clinical practice. Pharmacotherapy 2011; 31: 1175-91.
42. Kubitza D, Becka M, Mueck W, et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct factor Xa inhibitor. Br J Clin Pharmacol 2010; 70: 703-12.
43. Mueck W, Borris LC, Dahl OE, 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: 453-61.
44. Xu XS, Moore K, Burton P, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with acute coronary syndromes. Br J Clin Pharmacol 2012; 74: 86-97.
45. U.S. Food and Drug Administration. Xarelto Prescribing Information. Available from http://www.xareltohcp.com/sites/default/files/pdf/xarelto-0. pdf#zoom=100. Accessed March 27, 2013.
46. European Medicines Association. Xarelto EPAR Product Information. Available from http://www.ema.europa.eu/docs/en-GB/document-library/EPAR- Product-Information/human/000944/WC500057108.pdf. Accessed January 22, 2013.
47. Bauer KA, Homering M, Berkowitz S,. 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 2008; 112: 436.
48. Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J 2011; 32: 2387-94.
49. The EINSTEIN investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-510 (Supplement).
50. The EINSTEIN investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-97 (Supplement).
51. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med 2012; 366: 9-19 (Supplement).
52. The Executive Steering Committee on behalf of the ROCKET-AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J 2010; 159: 340-7 e1.
53. Patel MR, Hellkamp AS, Lokhnygina Y, et al. Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET-AF trial (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). J Am Coll Cardiol 2013; 61 (6): 651-8.
54. Janssen Pharmaceuticals. Data on File. Xarelto temporary interruption in ROCKET-AF. Titusville, NJ; 2012.
55. Turpie AG, Kreutz R, Llau J, Norrving B, Haas S,. Management consensus guidance for the use of rivaroxaban-an oral, direct factor Xa inhibitor. Thromb Haemost 2012; 108: 876-86.
56. Schulman S, Crowther MA,. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood 2012; 119: 3016-23.
57. Douketis JD,. Pharmacologic properties of the new oral anticoagulants: a clinician-oriented review with a focus on perioperative management. Curr Pharm Des 2010; 16: 3436-41.
58. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 Suppl): e326S-50S.
59. Horlocker TT, Wedel DJ, Rowlingson JC, et al. Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition). Reg Anesth Pain Med 2010; 35: 64-101.
60. Janssen Research & Development, LLC. Advisory committee briefing document. Available from http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM304757.pdf. Accessed January 22, 2013.
61. U. S. Food and Drug Administration. Briefing information for the March 19, 2009 meeting of the cardiovascular and renal drugs advisory committee. Available from http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM181524.pdf. Accessed January 22, 2013.
62. Johnson & Johnson Pharmaceutical Research & Development. Advisory Committee Briefing Book. Prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement or knee replacement surgery. Available from http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM138385.pdf. Accessed January 22, 2013.
63. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91 (Supplement).
64. Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol 2012; 87 (Suppl 1): S141-5.
65. Tinel H, Huetter J, Perzborn E,. Recombinant factor VIIa partially reverses the anticoagulant effect of high-dose rivaroxaban a novel, oral, direct factor Xa inhibitor in rats. J Thromb Haemost 2007; 5: P-W-652.
66. Gruber A, Marzec UM, Buetehorn U, Hanson S, Perzborn E,. Potential of activated prothrombin complex concentrate and activated factor VII to reverse the anticoagulant effects of rivaroxaban in primates. Blood 2008; 112: 3825.
67. Godier A, Miclot A, Le Bonniec B, et al. Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model. Anesthesiology 2012; 116: 94-102.
68. Perzborn ETA, Selback K, Tinel H,. Prothrombin complex concentrate reverses the effects of high-dose rivaroxaban in rats. J Thromb Haemost 2009; 379 (Suppl 2): PP-MO-183.
69. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M,. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011; 124: 1573-9.
70. Marlu R, Hodaj E, Paris A, Albaladejo P, Crackowski JL, Pernod G,. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban. A randomised crossover ex vivo study in healthy volunteers. Thromb Haemost 2012; 108: 217-24.
71. Haynes LM, Orfeo T, Mann KG,. Rivaroxaban delivery and reversal at a venous flow rate. Arterioscler Thromb Vasc Biol 2012; 32: 2877-83.
72. U.S. Food and Drug Administration. Drug development and drug interactions: table of substrates, inhibitors and inducers. Available from http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/ druginteractionslabeling/ucm093664.htm#inhibitors. Accessed January 22, 2013.
73. Kubitza D, Becka M, Mueck W, Zuehlsdorf M,. Rivaroxaban (BAY 59-7939)-an oral, direct factor Xa inhibitor-has no clinically relevant interaction with naproxen. Br J Clin Pharmacol 2007; 63: 469-76.
74. Moore KT, Vaidyanathan S, Damaraju CV, Fields LE,. The relative bioavailability of a single-dose rivaroxaban, a novel oral anticoagulant and selective direct factor Xa inhibitor, administered orally (as a whole or crushed tablet) and via nasogastric tube (as a crushed tablet suspension) (abstract 28). Pharmacotherapy 2012; 32: e185.
75. Lansberg MG, O'Donnell MJ, Khatri P, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 Suppl): e601S-36S.
76. National Institute of Neurologic Disorders and Stroke rTPA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995; 333: 1581-7.
77. Abhishek F, Heist EK, Barrett C, et al. Effectiveness of a strategy to reduce major vascular complications from catheter ablation of atrial fibrillation. J Interv Card Electrophysiol 2011; 30: 211-5.
78. Lakkireddy D, Reddy YM, Di Biase L, et al. Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 2012; 59: 1168-74.
79. De Caterina R, Husted S, Wallentin L, et al. New oral anticoagulants in atrial fibrillation and acute coronary syndromes: ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease position paper. J Am Coll Cardiol 2012; 59: 1413-25.
80. ATLAS ACS-TIMI 51 protocol. Available from http://www.nejm.org/doi/suppl/ 10.1056/NEJMoa1112277/suppl-file/nejmoa1112277-protocol.pdf. Accessed January 22, 2013.
81. Faxon DP, Eikelboom JW, Berger PB, et al. Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting: a North American perspective: executive summary. Circ Cardiovasc Interv 2011; 4: 522-34.
82. Faxon DP, Eikelboom JW, Berger PB, et al. Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. A North-American perspective. Thromb Haemost 2011; 106: 572-84.
83. Mega JL, Braunwald E, Mohanavelu S, et al. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet 2009; 374 (9683): 29-38.
84. 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: 218-26.
85. Turpie AG, Lassen MR, Eriksson BI, et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2011; 105: 444-53.
86. ClinicalTrials.gov. Switching Study from Warfarin to Rivaroxaban. Available from http://www.clinicaltrials.gov/ct2/show/NCT01507051?term= rivaroxaban&rank=2. Accessed January 22, 2013.
87. ClinicalTrials.gov. A study to explore the pharmacodynamic changes when transitioning from rivaroxaban to warfarin in healthy volunteers. Available from http://www.clinicaltrials.gov/ct2/show/NCT01400646?term=NCT01400646&rank=1. Accessed January 22, 2013.
88. Nutescu EA, Wittkowsky AK, Burnett A, Merli GJ, Ansell JE, Garcia DA,. Delivery of optimal inpatient anticoagulation therapy: consensus statement from the Anticoagulation Forum. Ann Pharmacother 2013; April 12 [epub ahead of print].
89. Kagansky N, Knobler H, Rimon E, Ozer Z, Levy S,. Safety of anticoagulation therapy in well-informed older patients. Arch Intern Med 2004; 164: 2044-50.
90. Pernod G, Labarere J, Yver J, et al. EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study. J Gen Intern Med 2008; 23: 1441-6.
91. Garcia DA, Witt DM, Hylek E, et al. Delivery of optimized anticoagulant therapy: consensus statement from the Anticoagulation Forum. Ann Pharmacother 2008; 42: 979-88.
92. Olson DP, Windish DM,. Communication discrepancies between physicians and hospitalized patients. Arch Intern Med 2010; 170: 1302-7.
93. Spinler SA,. Oral anticoagulants. In:, Levine, GN, ed. Cardiology secrets, 4th ed. Philadelphia, PA: Elsevier, 2013; (in press).
94. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med 2006; 166: 565-71.
95. Xarelto CarePath. Supporting your journey. Available from http://www.xareltocarepath.com. Accessed January 22, 2013.
96. U.S. Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategy. Xarelto (rivaroxaban) tablets risk and mitigation strategy. Available from http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM295405.pdf. Accessed January 22, 2013.
97. Grande D,. The cost of drug coupons. JAMA 2012; 307: 2375-6.
98. Schulman S, Anderson DR, Bungard TJ, et al. Direct and indirect costs of management of long-term warfarin therapy in Canada. J Thromb Haemost 2010; 8: 2192-200.
99. Xarelto (rivaroxaban tablets) Prescribing Information. Janssen Pharmaceuticals, Inc. Titusville, NJ; March 2013. Available from http://www.xareltohcp.com/sites/default/files/pdf/xarelto-0.pdf#zoom=100. Accessed March 25, 2013.