Stop the clots, but at what cost? Pharmacoeconomics of dabigatran etexilate for the prevention of stroke in subjects with atrial fibrillation: A systematic literature review

Expert Review of Pharmacoeconomics and Outcomes Research

Volumn 13, Issue 1, 2013, Pages 29-42

  Marshall, Sarah ^a   Fearon, Patricia ^a   Dawson, Jesse ^a   Quinn, Terence J ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

anticoagulants; cost efficacy; dabigatran; economics; stroke; warfarin

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; DABIGATRAN ETEXILATE; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; WARFARIN; XIMELAGATRAN;

ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; COST BENEFIT ANALYSIS; COST UTILITY ANALYSIS; DOSE RESPONSE; DRUG COST; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; EMBOLISM PREVENTION; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER TOXICITY; LOW DRUG DOSE; MORBIDITY; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL (TOPIC); PREVALENCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SYSTEMATIC REVIEW; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM;

ANTICOAGULANTS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; COST-BENEFIT ANALYSIS; DRUG COSTS; HUMANS; PATIENT SELECTION; PREVENTIVE HEALTH SERVICES; PYRIDINES; RISK ASSESSMENT; RISK FACTORS; STROKE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84873921806     PISSN: 14737167     EISSN: 17448379     Source Type: Journal    
DOI: 10.1586/erp.12.79     Document Type: Article

References (59)

1. Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fbrillation and futter in the United States. Am. J. Cardiol. 104(11), 1534-1539 (2009).
2. Miyasaka Y, Barnes ME, Gersh BJ et al. Secular trends in incidence of atrial fbrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation 114 (2), 119-125 (2006).
3. Gage BF, van Walraven C, Pearce L et al. Selecting patients with atrial fbrillation for anticoagulation: stroke risk stratifcation in patients taking aspirin. Circulation 110(16), 2287-2292 (2004).
4. Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fbrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J. Am. Coll. Cardiol. 57(2), 173-180 (2011).
5. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refning clinical risk stratifcation for predicting stroke and thromboembolism in atrial fbrillation using a novel risk factor-based approach: the Euro Heart Survey on atrial fbrillation. Chest 137(2), 263-272 (2010).
6. Rosamond W, Flegal K, Furie K et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 117(4), e25-e146 (2008).
7. Luengo-Fernandez R, Gray AM, Rothwell PM. Population-based study of determinants of initial secondary care costs of acute stroke in the United Kingdom. Stroke 37(10), 2579-2587 (2006).
8. Flaherty ML. Anticoagulant-associated intracerebral hemorrhage. Semin. Neurol. 30(5), 565-572 (2010).
9. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fbrillation. Ann. Intern. Med. 146(12), 857-867 (2007).
10. Connolly S, Pogue J, Hart R; on behalf of the ACTIVE Investigators. Clopidogrel plus aspirin versus oral anticoagulation for atrial fbrillation in the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE W): a randomized controlled trial. Lancet 367, 1903-1912 (2006).
11. Mant J, Hobbs FD, Fletcher K et al.; BAFTA investigators; Midland Research Practices Network (MidReC). Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fbrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 370(9586), 493-503 (2007).
12. Sato H, Ishikawa K, Kitabatake A et al.; Japan Atrial Fibrillation Stroke Trial Group. Low-dose aspirin for prevention of stroke in low-risk patients with atrial fbrillation: Japan Atrial Fibrillation Stroke Trial. Stroke 37(2), 447-451 (2006).
13. Atrial Fibrillation Investigators. Risk factors for stroke and effcacy of antithrombotic therapy in atrial fbrillation. Analyses of pooled data from fve randomized controlled trials. Arch. Int. Med. 154, 1449-1457 (1994).
14. McArthur KS, Quinn TJ, Higgins P, Lang-horne P. Post-acute care and secondary prevention after ischaemic stroke. BMJ 342, d2083 (2011).
15. Marinigh R, Lip GY, Fiotti N, Giansante C, Lane DA. Age as a risk factor for stroke in atrial fbrillation: implications for thromboprophylaxis. J. Am. Coll. Cardiol 56, 827-837 (2010).
16. Morgan CL, McEwan P, Tukiendorf A, Robinson PA, Clemens A, Plumb JM. Warfarin treatment in patients with atrial fbrillation: observing outcomes associated with varying levels of INR control. Thromb. Res. 124(1), 37-41 (2009).
17. Baker WL, Cios DA, Sander SD, Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fbrillation patients in the United States. J. Manag Care Ph arm. 15(3), 244-252 (2009).
18. Avery T, Barber N, Ghaleb M et al. Investigating the prevalence and causes of prescribing errors in general practice: the PRACtICe Study. General Medical Council (UK) Report (2012).
19. Kent AJ, O'Beirne J, Negus R. The patient with haematemesis and melaena. Acute Med. 10(1), 45-49 (2011).
20. Olsen SB; on behalf of the Executive Steering Committee of the SPORTIF III investigators. Stroke prevention with the oral direct thrombin inhibitor ximalegatran compared with warfarin in patients with non-valvular atrial fbrillation (SPORTIF III) randomized controlled trial. Lancet 362, 1691-1698 (2003).
21. Di Nisio M, Middeldorp S, Büller HR. Direct thrombin inhibitors. N. Engl. J. Med. 353(10), 1028-1040 (2005).
22. Eriksson BI, Dahl OE, Rosencher N et al.; RE-MODEL Study Group. Oral dabi-gatran etexilate vs. subcutaneous enoxapa-rin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J. Thromb. Haemost. 5(11), 2178-2185 (2007).
23. Ginsberg JS, Davidson BL Comp PC; on behalf of the RE-MOBILIZE Writing Committee. The oral thrombin inhibitor dabigatran etexilate vs the North American enoxaparin regimen for the prevention of venous thromboembolism after knee arthroplasty surgery. J. Arhroplasty. 24, 1-9 (2008).
24. Eriksson BI, Dahl OE, Rosencher N et al.; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 370 (9591), 949-956 (2007).
25. Ezekowitz MD, Reilly PA, Nehmiz G et al Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fbrillation (PETRO Study). Am. J. Cardiol. 100(9), 1419-1426 (2007).
26. Connolly SJ, Ezekowitz MD, Yusuf S et al.; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fbrillation. N. Engl. J. Med. 361(12), 1139-1151 (2009).
27. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identifed events in the RE-LY trial. N. Engl. J. Med. 363(19), 1875-1876 (2010).
28. Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fbrillation. JAMA 293, 690-698 (2005).
29. Patel MR, Mahaffey K W, Garg J et al.; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fbrillation. N. Engl. J. Med. 365 (10), 883-891 (2011).
30. Granger CB, Alexander JH, McMurray JJ et al.; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fbrillation. N. Engl. J. Med. 365(11), 981-992 (2011).
31. Wallentin L, Yusuf S, Ezekowitz MD et al.; RE-LY investigators. Effcacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fbrillation: an analysis of the RE-LY trial. Lancet 376(9745), 975-983 (2010).
32. Diener HC, Connolly SJ, Ezekowitz MD et al.; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fbrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 9 (12), 1157-1163 (2010).
33. Eikelboom JW, Wallentin L, Connolly SJ et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fbrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 123 (21), 2363-2372 (2011).
34. Garber ST, Sivakumar W, Schmidt RH. Neurosurgical complications of direct thrombin inhibitors-catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran. J. Neurosurg. 116(5), 1093-1096 (2012).
35. Boehringer Ingelheim Drug Safety Database. Suspected cases reported from March 2008-October 2011 (2012).
36. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. 23(8), 1296-1310 (2001).
37. Hohnloser SH, Oldgren J, Yang S et al. Myocardial ischemic events in patients with atrial fbrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation 125(5), 669-676 (2012).
38. Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch. Intern. Med. 172(5), 397-402 (2012).
39. Banerjee A, Lane DA, Torp-Pedersen C, Lip GY. Net clinical beneft of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fbrillation population: a modelling analysis based on a nationwide cohort study Thromb. Haemost. 107(3), 584-589 (2012).
40. Fuster V, Ryden LE, Cannom DS et al. ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fbrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 123, e269-e367 (2011).
41. Skanes AC, Healey JS, Cairns JA et al.; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. Focused 2012 update of the Canadian Cardiovascular Society atrial fbrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can. J. Cardiol. 28(2), 125-136 (2012).
42. Wolowacz SE. Pharmacoeconomics of dabigatran etexilate for prevention of thromboembolism after joint replacement surgery. Expert Rev. Pharmacoecon. Outcomes Res. 11(1), 9-25 (2011).
43. Freeman JV, Zhu RP, Owens DK et al Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fbrillation. Ann. Intern. Med. 154, 1-11 (2011).
44. Gage BF, Cardinalli AB, Owens DK. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch. Intern. Med. 156(16), 1829-1836 (1996).
45. O'Brien CL, Gage BF. Costs and effectiveness of ximelagatran for stroke prophylaxis in chronic atrial fbrillation. JAMA 293(6), 699-706 (2005).
46. Freeman JV, Turakhia MP. Letter. Ann. Int. Med. 154(8), 570-571 (2011).
47. Sorensen SV, Kansal AR, Connolly S et al. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fbrillation: a Canadian payer perspective. Thromb. Haemost. 105(5), 908-919 (2011).
48. van Walraven C, Oake N, Wells PS, Forster AJ. Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly. Chest 131(5), 1508-1515 (2007).
49. Roskell NS, Lip GY, Noack H, Clemens A, Plumb JM. Treatments for stroke prevention in atrial fbrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb. Haemost. 104 (6), 1106-1115 (2010).
50. Mittman N, Saing SI, Sharma M et al. Impact of disability status on ischaemic stroke costs. Stroke 41, e390 (2010).
51. Sullivan PW, Arant TW, Ellis SL, Ulrich H. The cost-effectiveness of anticoagulation management services for patients with atrial fbrillation and at high risk of stroke in the US. Pharmacoeconomics 24 (10), 1021-1033 (2006).
52. Tengs TO, Lin TH. A meta-analysis of quality-of-life estimates for stroke. Pharmacoeconomics 21(3), 191-200 (2003).
53. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fbrillation. Circulation 123(22), 2562-2570 (2011).
54. Pink J, Lane S, Pirmohamed M, Hughes DA. Dabigatran etexilate versus warfarin in management of non-valvular atrial fbrillation in UK context: quantitative beneft-harm and economic analyses. BMJ 343, d6333 (2011).
55. Sullivan PW, Ghushchyan V. Preference-based EQ-5D index scores for chronic conditions in the United States. Med. Decis. Making 26(4), 410-420 (2006).
56. Kamel H, Johnston SC, Easton JD, Kim AS. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fbrillation and prior stroke or transient ischemic attack. Stroke 43(3), 881-883 (2012).
57. Quinn TJ, Dawson J. Acute 'strokenomics': effcacy and economic analyses of alteplase for acute ischemic stroke. Expert Rev. Pharmacoecon. Outcomes Res. 9(6), 513-522 (2009).
58. Contractor T, Khasnis A. Left atrial appendage closure in atrial fbrillation: a world without anticoagulation? Cardiol. Res. Pract. 30, 752-808 (2011).
59. Healey JS, Connolly SJ, Gold MR et al.; ASSERT Investigators. Subclinical atrial fbrillation and the risk of stroke. N. Engl. J. Med. 366(2), 120-129 (2012).