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Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study
Hsien-Yen Chang1, Meijia Zhou2, Wenze Tang3
1Department of Health Policy and Management, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA hchang24@jhmi.edu.
Insights
This study compared the real-world safety of dabigatran and rivaroxaban to warfarin for gastrointestinal bleeding. While observed rates varied, adjusted analyses showed no significant differences in bleeding risk between these anticoagulants.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Health Services Research
Background:
- Direct oral anticoagulants (DOACs) like dabigatran and rivaroxaban offer alternatives to warfarin for preventing thromboembolic events.
- Real-world safety data, particularly concerning gastrointestinal (GI) bleeding, is crucial for comparing these anticoagulants.
- Warfarin, a vitamin K antagonist, has a well-established safety profile but requires regular monitoring.
Purpose of the Study:
- To compare the real-world safety of dabigatran and rivaroxaban versus warfarin concerning gastrointestinal bleeding.
- To assess the comparative risk of GI bleeding in patients initiating these oral anticoagulants.
Main Methods:
- Retrospective cohort study utilizing a large US administrative database of commercially insured individuals.
- Included 46,163 adult patients prescribed warfarin, dabigatran, or rivaroxaban between October 2010 and March 2012, with no prior anticoagulant use or GI bleeding.
- Time to gastrointestinal bleeding was the primary outcome, analyzed using Cox proportional hazard models with propensity score weighting.
Main Results:
- The rate of gastrointestinal bleeding was highest in dabigatran users (9.01/100 person-years) and lowest in rivaroxaban users (3.41/100 person-years), compared to warfarin (7.02/100 person-years).
- After adjusting for covariates, no statistically significant difference in GI bleeding risk was found between dabigatran and warfarin (aHR 1.21) or rivaroxaban and warfarin (aHR 0.98).
- Dabigatran users were older and more likely to be male than rivaroxaban or warfarin users.
Conclusions:
- In this commercially insured US population, observed gastrointestinal bleeding rates appeared similar across dabigatran, rivaroxaban, and warfarin.
- The study could not exclude a potential increase in GI bleeding risk of up to 50% for dabigatran or over twofold for rivaroxaban compared to warfarin.
- Further research with larger sample sizes and longer follow-up may be needed to definitively establish comparative safety profiles.
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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