Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation

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Standard

Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation. / Souverein, Patrick C.; van den Ham, Hendrika A.; Huerta, Consuelo; Merino, Elisa Martin; Montero, Dolores; Leon-Munoz, Luz M.; Schmiedl, Sven; Heeke, Andreas; Rottenkolber, Marietta; Andersen, Morten; Aakjaer, Mia; De Bruin, Marie L.; Klungel, Olaf H.; Gardarsdottir, Helga.

I: British Journal of Clinical Pharmacology, Bind 87, Nr. 3, 2021, s. 988-1000.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Souverein, PC, van den Ham, HA, Huerta, C, Merino, EM, Montero, D, Leon-Munoz, LM, Schmiedl, S, Heeke, A, Rottenkolber, M, Andersen, M, Aakjaer, M, De Bruin, ML, Klungel, OH & Gardarsdottir, H 2021, 'Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation', British Journal of Clinical Pharmacology, bind 87, nr. 3, s. 988-1000. https://doi.org/10.1111/bcp.14450

APA

Souverein, P. C., van den Ham, H. A., Huerta, C., Merino, E. M., Montero, D., Leon-Munoz, L. M., Schmiedl, S., Heeke, A., Rottenkolber, M., Andersen, M., Aakjaer, M., De Bruin, M. L., Klungel, O. H., & Gardarsdottir, H. (2021). Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation. British Journal of Clinical Pharmacology, 87(3), 988-1000. https://doi.org/10.1111/bcp.14450

Vancouver

Souverein PC, van den Ham HA, Huerta C, Merino EM, Montero D, Leon-Munoz LM o.a. Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation. British Journal of Clinical Pharmacology. 2021;87(3): 988-1000. https://doi.org/10.1111/bcp.14450

Author

Souverein, Patrick C. ; van den Ham, Hendrika A. ; Huerta, Consuelo ; Merino, Elisa Martin ; Montero, Dolores ; Leon-Munoz, Luz M. ; Schmiedl, Sven ; Heeke, Andreas ; Rottenkolber, Marietta ; Andersen, Morten ; Aakjaer, Mia ; De Bruin, Marie L. ; Klungel, Olaf H. ; Gardarsdottir, Helga. / Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation. I: British Journal of Clinical Pharmacology. 2021 ; Bind 87, Nr. 3. s. 988-1000.

Bibtex

@article{d6694e78da6f45d3978c397cf4acc49e,
title = "Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation",
abstract = "Aims The introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for nonvalvular atrial fibrillation, but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed. The aim of this study was to characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from 4 different EU-countries analysed with a common study protocol. Methods A cohort study was conducted among new users (>= 18 years) of DOACs or VKAs with nonvalvular atrial fibrillation using data from the UK, Spain, Germany and Denmark. The incidence of major bleeding events (overall and by bleeding site) was compared between current use of DOACs and VKAs. Cox regression analysis was used to calculate hazard ratios and 95% confidence intervals (CI) and adjust for confounders. Results/Conclusion Overall, 251 719 patients were included across the 4 study cohorts (mean age similar to 75 years, % females between 41.3 and 54.3%), with overall hazard ratios of major bleeding risk for DOACsvsVKAs ranging between 0.84 (95% CI: 0.79-0.90) in Denmark and 1.13 (95% CI 1.02-1.25) in the UK. When stratifying according to the bleeding site, risk of gastrointestinal bleeding was increased by 48-67% in dabigatran users and 30-50% for rivaroxaban users compared to VKA users in all data sources except Denmark. Compared to VKAs, apixaban was not associated with an increased risk of gastrointestinal bleeding in all data sources and seemed to be associated with the lowest risk of major bleeding events compared to dabigatran and rivaroxaban.",
keywords = "atrial fibrillation, cohort study, major bleeding, non-vitamin K antagonist oral anticoagulants, pharmacoepidemiology, vitamin K antagonists, VITAMIN-K ANTAGONISTS, MORTALITY RISKS, WARFARIN, DABIGATRAN, RIVAROXABAN, SAFETY, APIXABAN, STROKE, METAANALYSIS, MANAGEMENT",
author = "Souverein, {Patrick C.} and {van den Ham}, {Hendrika A.} and Consuelo Huerta and Merino, {Elisa Martin} and Dolores Montero and Leon-Munoz, {Luz M.} and Sven Schmiedl and Andreas Heeke and Marietta Rottenkolber and Morten Andersen and Mia Aakjaer and {De Bruin}, {Marie L.} and Klungel, {Olaf H.} and Helga Gardarsdottir",
year = "2021",
doi = "10.1111/bcp.14450",
language = "English",
volume = "87",
pages = " 988--1000",
journal = "British Journal of Clinical Pharmacology, Supplement",
issn = "0264-3774",
publisher = "Wiley-Blackwell",
number = "3",

}

RIS

TY - JOUR

T1 - Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation

AU - Souverein, Patrick C.

AU - van den Ham, Hendrika A.

AU - Huerta, Consuelo

AU - Merino, Elisa Martin

AU - Montero, Dolores

AU - Leon-Munoz, Luz M.

AU - Schmiedl, Sven

AU - Heeke, Andreas

AU - Rottenkolber, Marietta

AU - Andersen, Morten

AU - Aakjaer, Mia

AU - De Bruin, Marie L.

AU - Klungel, Olaf H.

AU - Gardarsdottir, Helga

PY - 2021

Y1 - 2021

N2 - Aims The introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for nonvalvular atrial fibrillation, but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed. The aim of this study was to characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from 4 different EU-countries analysed with a common study protocol. Methods A cohort study was conducted among new users (>= 18 years) of DOACs or VKAs with nonvalvular atrial fibrillation using data from the UK, Spain, Germany and Denmark. The incidence of major bleeding events (overall and by bleeding site) was compared between current use of DOACs and VKAs. Cox regression analysis was used to calculate hazard ratios and 95% confidence intervals (CI) and adjust for confounders. Results/Conclusion Overall, 251 719 patients were included across the 4 study cohorts (mean age similar to 75 years, % females between 41.3 and 54.3%), with overall hazard ratios of major bleeding risk for DOACsvsVKAs ranging between 0.84 (95% CI: 0.79-0.90) in Denmark and 1.13 (95% CI 1.02-1.25) in the UK. When stratifying according to the bleeding site, risk of gastrointestinal bleeding was increased by 48-67% in dabigatran users and 30-50% for rivaroxaban users compared to VKA users in all data sources except Denmark. Compared to VKAs, apixaban was not associated with an increased risk of gastrointestinal bleeding in all data sources and seemed to be associated with the lowest risk of major bleeding events compared to dabigatran and rivaroxaban.

AB - Aims The introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for nonvalvular atrial fibrillation, but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed. The aim of this study was to characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from 4 different EU-countries analysed with a common study protocol. Methods A cohort study was conducted among new users (>= 18 years) of DOACs or VKAs with nonvalvular atrial fibrillation using data from the UK, Spain, Germany and Denmark. The incidence of major bleeding events (overall and by bleeding site) was compared between current use of DOACs and VKAs. Cox regression analysis was used to calculate hazard ratios and 95% confidence intervals (CI) and adjust for confounders. Results/Conclusion Overall, 251 719 patients were included across the 4 study cohorts (mean age similar to 75 years, % females between 41.3 and 54.3%), with overall hazard ratios of major bleeding risk for DOACsvsVKAs ranging between 0.84 (95% CI: 0.79-0.90) in Denmark and 1.13 (95% CI 1.02-1.25) in the UK. When stratifying according to the bleeding site, risk of gastrointestinal bleeding was increased by 48-67% in dabigatran users and 30-50% for rivaroxaban users compared to VKA users in all data sources except Denmark. Compared to VKAs, apixaban was not associated with an increased risk of gastrointestinal bleeding in all data sources and seemed to be associated with the lowest risk of major bleeding events compared to dabigatran and rivaroxaban.

KW - atrial fibrillation

KW - cohort study

KW - major bleeding

KW - non-vitamin K antagonist oral anticoagulants

KW - pharmacoepidemiology

KW - vitamin K antagonists

KW - VITAMIN-K ANTAGONISTS

KW - MORTALITY RISKS

KW - WARFARIN

KW - DABIGATRAN

KW - RIVAROXABAN

KW - SAFETY

KW - APIXABAN

KW - STROKE

KW - METAANALYSIS

KW - MANAGEMENT

U2 - 10.1111/bcp.14450

DO - 10.1111/bcp.14450

M3 - Journal article

C2 - 32627222

VL - 87

SP - 988

EP - 1000

JO - British Journal of Clinical Pharmacology, Supplement

JF - British Journal of Clinical Pharmacology, Supplement

SN - 0264-3774

IS - 3

ER -

ID: 248149485