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Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study

Objectives To determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding. Design Retrospective cohort study. Setting Large administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012....

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Autores principales: Chang, Hsien-Yen, Zhou, Meijia, Tang, Wenze, Alexander, G Caleb, Singh, Sonal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413867/
https://www.ncbi.nlm.nih.gov/pubmed/25911526
http://dx.doi.org/10.1136/bmj.h1585
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author Chang, Hsien-Yen
Zhou, Meijia
Tang, Wenze
Alexander, G Caleb
Singh, Sonal
author_facet Chang, Hsien-Yen
Zhou, Meijia
Tang, Wenze
Alexander, G Caleb
Singh, Sonal
author_sort Chang, Hsien-Yen
collection PubMed
description Objectives To determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding. Design Retrospective cohort study. Setting Large administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012. Participants Enrollees with a prescription of warfarin, dabigatran, or rivaroxaban between 1 October 2010 and 31 March 2012, who were aged 18 years or older, had continuous enrollment and no oral anticoagulant use during the six months before the entry date, with known age and sex, and with no gastrointestinal bleeding for at least six months before the cohort entry date. The final study sample of 46 163 patients included 4907 using dabigatran, 1649 using rivaroxaban, and 39 607 using warfarin. Main outcome measure Time to gastrointestinal bleeding. Hazard ratios were derived from Cox proportional hazard models with propensity score weighting and robust estimates of errors. Results Dabigatran users tended to be older (dabigatran v rivaroxaban v warfarin: 62.0 v 57.6 v 57.4 years) and more likely to be male (69% v 49% v 53%). The rate of gastrointestinal bleeding was highest among dabigatran users and lowest among rivaroxaban users (dabigatran v rivaroxaban v warfarin: 9.01 v 3.41 v 7.02 cases per 100 person years). After adjustment for potentially confounding covariates, there was no evidence of a statistically significant difference in the risk of gastrointestinal bleeding between dabigatran and warfarin users (adjusted hazard ratio 1.21, 95% confidence interval 0.96 to 1.53) or between rivaroxaban and warfarin users (0.98, 0.36 to 2.69). Conclusions Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.
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spelling pubmed-44138672015-05-11 Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study Chang, Hsien-Yen Zhou, Meijia Tang, Wenze Alexander, G Caleb Singh, Sonal BMJ Research Objectives To determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding. Design Retrospective cohort study. Setting Large administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012. Participants Enrollees with a prescription of warfarin, dabigatran, or rivaroxaban between 1 October 2010 and 31 March 2012, who were aged 18 years or older, had continuous enrollment and no oral anticoagulant use during the six months before the entry date, with known age and sex, and with no gastrointestinal bleeding for at least six months before the cohort entry date. The final study sample of 46 163 patients included 4907 using dabigatran, 1649 using rivaroxaban, and 39 607 using warfarin. Main outcome measure Time to gastrointestinal bleeding. Hazard ratios were derived from Cox proportional hazard models with propensity score weighting and robust estimates of errors. Results Dabigatran users tended to be older (dabigatran v rivaroxaban v warfarin: 62.0 v 57.6 v 57.4 years) and more likely to be male (69% v 49% v 53%). The rate of gastrointestinal bleeding was highest among dabigatran users and lowest among rivaroxaban users (dabigatran v rivaroxaban v warfarin: 9.01 v 3.41 v 7.02 cases per 100 person years). After adjustment for potentially confounding covariates, there was no evidence of a statistically significant difference in the risk of gastrointestinal bleeding between dabigatran and warfarin users (adjusted hazard ratio 1.21, 95% confidence interval 0.96 to 1.53) or between rivaroxaban and warfarin users (0.98, 0.36 to 2.69). Conclusions Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin. BMJ Publishing Group Ltd. 2015-04-24 /pmc/articles/PMC4413867/ /pubmed/25911526 http://dx.doi.org/10.1136/bmj.h1585 Text en © Chang et al 2015 http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Chang, Hsien-Yen
Zhou, Meijia
Tang, Wenze
Alexander, G Caleb
Singh, Sonal
Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title_full Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title_fullStr Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title_full_unstemmed Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title_short Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
title_sort risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413867/
https://www.ncbi.nlm.nih.gov/pubmed/25911526
http://dx.doi.org/10.1136/bmj.h1585
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