Evidence map›Paper›PMID 25911526›Full record

ArticleBMJ (Clinical research ed.)2015

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

Hsien-Yen Chang, Meijia Zhou, Wenze Tang, G Caleb Alexander, Sonal Singh

Open access · hybridAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ (Clinical research ed.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 3 pooled it
19.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 3 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
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  6. Anticoagulation Stewardship Program in the DOAC Era.Journal of clinical medicine · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Hsien-Yen ChangDepartment 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.
Meijia ZhouDepartment of Epidemiology, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
Wenze TangDepartment of Epidemiology and Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC 20052, USA.
G Caleb AlexanderDepartment of Epidemiology, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, MD 21205, USA.
Sonal SinghDepartment of Epidemiology, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, MD 21205, USA.
Johns Hopkins University · USJohns Hopkins Medicine · USMilken Institute · US

Funding

Televised Direct to Consumer Pharmaceutical Advertising and Patient OutcomesR01HL107345 · NHLBI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI ALEXANDER, G. CALEB, EMERY, SHERRY L · 2011 to 2014
$3.0M
NHLBI NIH HHS R01 HL107345
6 · The paper itself

Abstract

objectivesTo determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding.

designRetrospective cohort study.

settingLarge administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012.

participantsEnrollees 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 measureTime to gastrointestinal bleeding. Hazard ratios were derived from Cox proportional hazard models with propensity score weighting and robust estimates of errors.

resultsDabigatran 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).

conclusionsAlthough 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.

Indexed as

Administration, OralAdultAgedAge FactorsAnticoagulantsAtrial FibrillationBenzimidazolesbeta-AlanineDabigatranFemaleGastrointestinal HemorrhageHumansIncidenceMaleMiddle AgedMorpholinesAnticoagulantsBenzimidazolesbeta-AlanineDabigatranMorpholinesRivaroxabanThiophenesWarfarin

Identifiers

PMID25911526
PMCPMC4413867
OpenAlexW2082030900

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.