Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study

Gastroenterology

Volumn 152, Issue 5, 2017, Pages 1014-1022.e1

  Abraham, Neena S ^a,b   Noseworthy, Peter A ^b   Yao, Xiaoxi ^b   Sangaralingham, Lindsey R ^b   Shah, Nilay D ^b,c  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c OPTUM   (United States)

Author keywords

Anticoagulant; Atrial Fibrillation; Comparative Safety; Gastrointestinal Hemorrhage

Indexed keywords

APIXABAN; DABIGATRAN; RIVAROXABAN; ANTITHROMBIN; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE;

ADULT; AGED; ARTICLE; ATRIAL FIBRILLATION; CHADS2 SCORE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; PRESCRIPTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK FACTOR; RISK REDUCTION; ADOLESCENT; AGE; CHEMICALLY INDUCED; COHORT ANALYSIS; COMPLICATION; MIDDLE AGED; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODEL; STROKE; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; ANTITHROMBINS; ATRIAL FIBRILLATION; COHORT STUDIES; DABIGATRAN; FACTOR XA INHIBITORS; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODELS; PYRAZOLES; PYRIDONES; RETROSPECTIVE STUDIES; RIVAROXABAN; STROKE; YOUNG ADULT;

EID: 85016224393     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2016.12.018     Document Type: Article

References (25)

1. 1 Husted, S., Lip, G.Y., De, C.R., Recommendation on the nomenclature for oral anticoagulants: communication from the SSC of the ISTH: comment. J Thromb Haemost 13 (2015), 2130–2132.
2. 2 Desai, N.R., Krumme, A.A., Schneeweiss, S., et al. Patterns of initiation of oral anticoagulants in patients with atrial fibrillation- quality and cost implications. Am J Med 127 (2014), 1075–1082.
3. 3 Abraham, N.S., Singh, S., Alexander, G.C., et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ, 350, 2015, h1857.
4. 4 Holster, I.L., Valkhoff, V.E., Kuipers, E.J., et al. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology 145 (2013), 105–112.
5. 5 Ruff, C.T., Giugliano, R.P., Braunwald, E., et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 383 (2014), 955–962.
6. 6 Which oral anticoagullant for atrial fibrillation?. JAMA 315 (2016), 2117–2118.
7. 7 Graham, D.J., Reichman, M.E., Wernecke, M., et al. Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA Intern Med 176 (2016), 1662–1671.
8. 8 Chan, Y.H., Kuo, C.T., Yeh, Y.H., et al. Thromboembolic, bleeding, and mortality risks of rivaroxaban and dabigatran in asians with nonvalvular atrial fibrillation. J Am Coll Cardiol 68 (2016), 1389–1401.
9. 9 Holbrook, A., Dormuth, C., Morrow, R., et al. Comparative effectiveness and safety of oral anticoagulants for atrial fibrillation in real-world practice: a population-based cohort study protocol. BMJ Open, 6, 2016, e013263.
10. 10 Seeger, J.D., Bykov, K., Bartels, D.B., et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost 114 (2015), 1277–1289.
11. 11 Villines, T.C., Schnee, J., Fraeman, K., et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost 114 (2015), 1290–1298.
12. 12 Noseworthy, P., Yao, X., Abraham, N., et al. Direct comparison of dabigatran, rivaroxaban and apixaban for effectiveness and safety in non-valvular atrial fibrillation. Chest 150 (2016), 1302–1312.
13. 13 Lewis, J.D., Bilker, W.B., Brensinger, C., et al. Hospitalization and mortality rates from peptic ulcer disease and GI bleeding in the 1990s: relationship to sales of nonsteroidal anti-inflammatory drugs and acid suppression medications. Am J Gastroenterol 97 (2002), 2540–2549.
14. 14 Deyo, R.A., Cherkin, D.C., Ciol, M.A., Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 45 (1992), 613–619.
15. 15 Austin, P.C., Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 28 (2009), 3083–3107.
16. 16 Gayat, E., Resche-Rigon, M., Mary, J.Y., et al. Propensity score applied to survival data analysis through proportional hazards models: a Monte Carlo study. Pharm Stat 11 (2012), 222–229.
17. 17 Grambsch, P.M., Therneau, T.M., Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 81 (1994), 515–526.
18. 18 Avgil-Tsadok, M., Jackevicius, C.A., Essebag, V., et al. Dabigatran use in elderly patients with atrial fibrillation. Thromb Haemost 115 (2015), 152–160.
19. 19 Graham, D.J., Reichman, M.E., Wernecke, M., et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 131 (2015), 157–164.
20. 20 Romanelli, R.J., Nolting, L., Dolginsky, M., et al. Dabigatran versus warfarin for atrial fibrillation in real-world clinical practice: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes 9 (2016), 126–134.
21. 21 Lin, L., Lim, W.S., Zhou, H.J., et al. Clinical and safety outcomes of oral antithrombotics for stroke prevention in atrial fibrillation: a systematic review and network meta-analysis. J Am Med Dir Assoc, 16, 2015, 1103.
22. 22 Schneeweiss, S., Gagne, J.J., Patrick, A.R., et al. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 5 (2012), 480–486.
23. 23 Baker, W.L., Phung, O.J., Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes 5 (2012), 711–719.
24. 24 Morimoto, T., Crawford, B., Wada, K., et al. Comparative efficacy and safety of novel oral anticoagulants in patients with atrial fibrillation: a network meta-analysis with the adjustment for the possible bias from open label studies. J Cardiol 66 (2015), 466–474.
25. 25 Lip, G.Y., Mitchell, S.A., Liu, X., et al. Relative efficacy and safety of non-vitamin K oral anticoagulants for non-valvular atrial fibrillation: network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups. Int J Cardiol 204 (2016), 88–94.