Consistency of safety profile of new oral anticoagulants in patients with renal failure

Journal of Thrombosis and Haemostasis

Volumn 12, Issue 3, 2014, Pages 337-343

  Lega, J C ^a,b   Bertoletti, L ^b,c,d   Gremillet, C ^c   Boissier, C ^c   Mismetti, P ^b,c,d   Laporte, S ^b,d,e  

^a HOSPICES CIVILS DE LYON   (France)

^b University Jean Monnet of Saint Etienne EA3065   (France)

^c HÔPITAL NORD   (France)

^d INSERM   (France)

^e UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

Author keywords

Anticoagulants; Atrial fibrillation; Bleeding; Meta analysis; Renal insufficiency; Venous thromboembolism

Indexed keywords

ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; ATECEGATRAN METOXIL; BETRIXABAN; DABIGATRAN; DABIGATRAN ETEXILATE; DAREXABAN; EDOXABAN; ERIBAXABAN; LETAXABAN; N [2 [4 (1 METHYL 4 PIPERIDINYL) 1 PIPERAZINYL] 2 OXO 1 PHENYLETHYL] 1H INDOLE 6 CARBOXAMIDE; NEW DRUG; PEGNIVACOGIN; RIVAROXABAN; SOFIGATRAN; TTP 889; UNCLASSIFIED DRUG; WARFARIN; XIMELAGATRAN;

ARTICLE; BLEEDING; DRUG EFFICACY; DRUG EXCRETION; DRUG SAFETY; GLOMERULUS FILTRATION RATE; HUMAN; INTERNATIONAL NORMALIZED RATIO; KIDNEY FAILURE; META ANALYSIS; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEVERE RENAL IMPAIRMENT; SYSTEMATIC REVIEW; THROMBOSIS; URINARY EXCRETION;

ANTICOAGULANTS; ATRIAL FIBRILLATION; BLEEDING; META-ANALYSIS; RENAL INSUFFICIENCY; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; CLINICAL TRIALS, PHASE III AS TOPIC; GLOMERULAR FILTRATION RATE; HEMORRHAGE; HUMANS; RENAL INSUFFICIENCY; THROMBOSIS; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM; VITAMIN K; WARFARIN;

EID: 84896766005     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.12486     Document Type: Article

References (25)

1. Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J 2013; 11: 21.
2. Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369: 1406-15.
3. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-92.
4. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-51.
5. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-91.
6. Hart RG, Eikelboom JW, Ingram AJ, Herzog CA. Anticoagulants in atrial fibrillation patients with chronic kidney disease. Nat Rev Nephrol 2012; 8: 569-78.
7. Monreal M, Falga C, Valle R, Barba R, Bosco J, Beato JL, Maestre A. Venous thromboembolism in patients with renal insufficiency: findings from the RIETE Registry. Am J Med 2006; 119: 1073-9.
8. Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation 2013; 128: 2325-32.
9. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2013; 123: 2363-72.
10. Hohnloser SH, Hijazi Z, Thomas L, Alexander JH, Amerena J, Hanna M, Keltai M, Lanas F, Lopes RD, Lopez-Sendon J, Granger CB, Wallentin L. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J 2012; 33: 2821-30.
11. Ocak G, Lijfering WM, Verduijn M, Dekker FW, Rosendaal FR, Cannegieter SC, Vossen CY. Risk of venous thrombosis in patients with chronic kidney disease: identification of high-risk groups. J Thromb Haemost 2013; 11: 627-33.
12. Wong SS, Wilczynski NL, Haynes RB. Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. J Med Libr Assoc 2006; 94: 41-7.
13. Haynes RB, McKibbon KA, Wilczynski NL, Walter SD, Werre SR. Optimal search strategies for retrieving scientifically strong studies of treatment from Medline: analytical survey. BMJ 2005; 330: 1179.
14. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4.
15. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 1998; 17: 2815-34.
16. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
17. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7: 177-88.
18. Cucherat M, Boissel JP, Leizorovicz A, Haugh MC. EasyMA: a program for the meta-analysis of clinical trials. Comput Methods Programs Biomed 1997; 53: 187-90.
19. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21: 1539-58.
20. Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369: 799-808.
21. Food and Drug Administration. Dabigatran Advisory Committee Briefing Document. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/cardiovascularandrenaldrugsadvisorycommittee/ucm226009pdf. Accessed 10 June 2013.
22. ® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document. http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4069B1_01_AstraZeneca-Backgrounderpdf. Accessed 7 August 2013.
23. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361: 2342-52.
24. Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med 2013; 368: 709-18.
25. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093-104.