Comparative risk of major bleeding with new oral anticoagulants (NOACs) and phenprocoumon in patients with atrial fibrillation: a post-marketing surveillance study

Clinical Research in Cardiology

Volumn 106, Issue 8, 2017, Pages 618-628

  Hohnloser, Stefan H ^a   Basic, Edin ^b   Nabauer, Michael ^c  

^a GOETHE UNIVERSITY   (Germany)

^b PFIZER INC   (United States)

^c UNIVERSITY OF MUNICH   (Germany)

Author keywords

Apixaban; Atrial fibrillation; Dabigatran; Major bleeding; Phenprocoumon; Rivaroxaban

Indexed keywords

ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; APIXABAN; DABIGATRAN; NONSTEROID ANTIINFLAMMATORY AGENT; PHENPROCOUMON; PROTON PUMP INHIBITOR; RIVAROXABAN;

ADULT; AGE; AGED; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; CHADS2 SCORE; CHARLSON COMORBIDITY INDEX; CLINICAL OUTCOME; COHORT ANALYSIS; COMORBIDITY; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE ASSESSMENT; DRUG EFFICACY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HAS BLED SCORE; HUMAN; INTERNATIONAL NORMALIZED RATIO; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; PHASE 3 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; RETROSPECTIVE STUDY; RISK ASSESSMENT; SENSITIVITY ANALYSIS; CEREBROVASCULAR ACCIDENT; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPLICATION; FOLLOW UP; GERMANY; INCIDENCE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PROCEDURES;

ADMINISTRATION, ORAL; AGED; ANTICOAGULANTS; ATRIAL FIBRILLATION; FEMALE; FOLLOW-UP STUDIES; GERMANY; HEMORRHAGE; HUMANS; INCIDENCE; MALE; PHENPROCOUMON; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; STROKE;

EID: 85015188681     PISSN: 18610684     EISSN: 18610692     Source Type: Journal    
DOI: 10.1007/s00392-017-1098-x     Document Type: Article

References (19)

1. Wilke T, Groth A, Mueller S, Pfannkuche M, Verheyen F, Linder R, Maywald U, Bauersachs R, Breithardt G (2013) Incidence and prevalence of atrial fibrillation: an analysis based on 8.3 million patients. Europace 15:486–493
2. Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151
3. Patel MR, Mahaffey KW, Garg J, Pan G et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891
4. Granger CB, Alexander JH, McMurray JJ et al (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992
5. Giugliano RP, Ruff CT, Braunwald E et al (2013) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369:2093–2104
6. Verhoef TI, Redekop WK, Daly AK et al (2013) Pharmacogenetic-guided dosing coumarin anticoagulants: algorithms for warfarin, acenocoumarol and phenprocoumon. Br J Clin Pharmacol 77(4):626–641
7. Andersohn F, Walker J (2016) Characteristics and external validity of the German Health Risk Institute (HRI) database. Pharmacoepidemiol Drug Saf. doi:10.1002/pds.3895
8. Swart E, Gothe H, Geyer S, Jaunzeme J, Maier B, Grobe TG, Ihle P (2015) German Society for Social Medicine and Prevention; German Society for Epidemiology. Good Practice of Secondary Data Analysis (GPS): guidelines and recommendations. Gesundheitswesen 777:120–126
9. Hastie T, Tibshirani R, Friedman J (2009) The elements of statistical learning: data mining, inference and prediction, 2nd edn. Springer, Berlin
10. Schoenfeld D (1982) Partial residuals for the proportional hazards regression model. Biometrika 69:239–241
11. Robins JM, Hernán MA, Brumback B (2000) Marginal structural models and causal inference in epidemiology. Epidemiology 11:550–560
12. Hernán MA, Brumback B, Robins JM (2002) Estimating the causal effect of zidovudine on CD4 count with a marginal structural model for repeated measures. Stat Med 2:689–170913
13. Rosenbaum PR, Rubin DB (1983) The central role of the propensity score in observational studies for causal effects. Biometrika 70:41–55
14. Jahnchen E, Meinertz T, Gilfrich HJ, Groth U, Martini A (1976) The enantiomers of phenprocoumon: pharmacodynamic and pharmacokinetic studies. Clin Pharmacol Ther 20:342–349
15. Alan SG, Daniel S et al. (2015) Mini-sentinel medical product assessment: a protocol for assessment of dabigatran. https://www.sentinelsystem.org/sites/default/files/Drugs/Assessments/Mini-Sentinel_Protocol-for-Assessment-of-Dabigatran_0.pdf
16. Lip GY, Keshishian A, Kamble S, Pan X, Mardekian J, Horblyuk R, Hamilton M (2016) Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis. Thromb Haemost 116:975–986
17. Yao X, Abraham NS, Sangaralingham LR, Bellolio MF, McBane RD, Shah ND, Noseworthy PA (2016) Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. doi:10.1161/JAHA.116.003725
18. Graham DJ, Reichman ME, Wernecke M et al (2015) Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 131:157–164
19. Hernandez I, Baik SH, Piñera A, Zhang Y (2015) Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med 175:18–24