Dabigatran
The medicine inside Pradaxa. It is a blood thinner taken by mouth. In the RE-LY trial two doses were compared with warfarin in people with atrial fibrillation at risk of stroke. The higher dose gave fewer strokes or clots elsewhere in the body than warfarin with a similar rate of major bleeding. The lower dose gave a similar stroke rate with less major bleeding.
- Drug
- In this atlas
Overview
Technical summary
RxNorm ingredient 1546356. An oral direct thrombin inhibitor (RE-LY abstract). Tested against warfarin in RE-LY at 110 mg and 150 mg twice daily (claim cardio:claim-re-ly-dabigatran-vs-warfarin); brand name Pradaxa in the FDA record (NDA 022512), where the openFDA active ingredient is dabigatran etexilate mesylate. The numbers are on the claim.
About this drug
- Level
- Substance
- Mechanism
- An oral direct thrombin inhibitor (RE-LY abstract).
Claims and evidence
Context Adults with atrial fibrillation at moderate to high risk of stroke (RE-LY)
- Recipient
- Adult
- Population
- People with non-valvular atrial fibrillation at moderate to high risk of stroke, or systemic embolism, with at least one additional risk factor: previous ischemic stroke, transient ischemic attack or systemic embolism, left ventricular dysfunction, age 75 or older, or age 65 or older with diabetes, coronary artery disease or hypertension (registry wording).
- Care setting
- Not stated in the abstract or the registry record
- Geography
- International (the registry lists sites in many countries; they are recorded on the study)
- Life stage
- Adults aged 18 or older (registry minimum age)
- Follow-up
- Median follow-up of 2.0 years (abstract).
Eligibility: 2 inclusion criteria; 6 exclusion criteria
- Included
- Non-valvular atrial fibrillation at moderate to high risk of stroke
- At least one additional risk factor: previous ischemic stroke, transient ischemic attack or systemic embolism, left ventricular dysfunction, age 75 or older, or age 65 or older with diabetes, coronary artery disease or hypertension
- Excluded
- Prosthetic heart valves requiring anticoagulation per se
- Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
- Severe renal impairment (estimated creatinine clearance 30 mL/min or less)
- Active liver disease
- Contraindication to warfarin treatment
- Other exclusions are listed in the registry
In RE-LY, a noninferiority trial, 18,113 patients with atrial fibrillation and a risk of stroke were randomly assigned to fixed doses of dabigatran, 110 mg or 150 mg twice daily, given in a blinded fashion, or to adjusted-dose warfarin, given unblinded. The median follow-up was 2.0 years. The primary outcome, stroke or systemic embolism, occurred at 1.69% per year with warfarin, 1.53% per year with 110 mg of dabigatran (relative risk 0.91, 95% confidence interval 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year with 150 mg of dabigatran (relative risk 0.66, 95% CI 0.53 to 0.82; P<0.001 for superiority). Major bleeding occurred at 3.36% per year with warfarin, 2.71% per year with 110 mg of dabigatran (P=0.003) and 3.11% per year with 150 mg of dabigatran (P=0.31, no significant difference from warfarin). Hemorrhagic stroke occurred at 0.38% per year with warfarin, 0.12% with 110 mg and 0.10% with 150 mg (each P<0.001). The mortality rate was 4.13% per year with warfarin, 3.75% with 110 mg (P=0.13) and 3.64% with 150 mg (P=0.051).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Applies to Adult- People with non-valvular atrial fibrillation at moderate to high risk of stroke, or systemic embolism, with at least one additional risk factor: previous ischemic stroke, transient ischemic attack or systemic embolism, left ventricular dysfunction, age 75 or older, or age 65 or older with diabetes, coronary artery disease or hypertension (registry wording).
- Not stated in the abstract or the registry record
- International (the registry lists sites in many countries; they are recorded on the study)
- Adults aged 18 or older (registry minimum age)
- Certainty method
- Not assessed
- Limitations
- Abstract of the main report only. The warfarin arm was unblinded, and the abstract does not say what the registry or the full text say about adjudication. PubMed links a published erratum to the paper (N Engl J Med 2010 Nov 4;363(19):1877); what it changes was not read, so the numbers here may not match the corrected paper. The abstract and the registry both give 18,113 participants. The registry arms are labeled dose 1 and dose 2 without milligram values, and the doses are taken from the abstract. Dabigatran at 150 mg twice daily had major bleeding similar to warfarin, and mortality did not differ significantly for either dose.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (23)
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, METHODS, sentence 1, fragment 1
- How it applies
- Design and patient count (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, METHODS, sentence 1, fragment 2
- How it applies
- Doses and comparator (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, METHODS, sentence 2
- How it applies
- Median follow-up.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, METHODS, sentence 3
- How it applies
- Primary outcome.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 1
- How it applies
- Primary outcome with warfarin.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 2
- How it applies
- Primary outcome with 110 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 3
- How it applies
- Primary outcome with 150 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 1, fragment 4
- How it applies
- Superiority interval for 150 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 1
- How it applies
- Major bleeding with warfarin.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 2
- How it applies
- Major bleeding with 110 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 2, fragment 3
- How it applies
- Major bleeding with 150 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 1
- How it applies
- Hemorrhagic stroke with warfarin.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 2
- How it applies
- Hemorrhagic stroke with dabigatran.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 4, fragment 1
- How it applies
- Mortality with warfarin and 110 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, RESULTS, sentence 4, fragment 2
- How it applies
- Mortality with 150 mg.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 1, fragment 1
- How it applies
- The authors' conclusion for 110 mg (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 1, fragment 2
- How it applies
- The authors' conclusion for 110 mg (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 2, fragment 1
- How it applies
- The authors' conclusion for 150 mg (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 2, fragment 2
- How it applies
- The authors' conclusion for 150 mg (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- Abstract, BACKGROUND, sentence 2
- How it applies
- Dabigatran is an oral direct thrombin inhibitor.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Newly identified events in the RE-LY trial
- Locator
- PubMed record of PMID 21047252, ArticleTitle
- How it applies
- A letter in the same journal issue as the erratum is titled Newly identified events in the RE-LY trial. Its text was not read, and the abstract rates here are the 2009 values.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
68370e0f1cd169d507461b8679e7a57049bc13b44a4bc9244e7a4886063c9e2e- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-21047252.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Dabigatran versus warfarin in patients with atrial fibrillation
- Locator
- PubMed record, CommentsCorrections (ErratumIn)
- How it applies
- PubMed links a published erratum whose content was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-19717844.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
- Locator
- protocolSection.designModule.enrollmentInfo.count
- How it applies
- Registry enrollment count, equal to the abstract.
- Retrieved
- Source effective date
- 2011-02-10
- Source state
- Current
- Snapshot hash
154435b06ce58ac9fb39bc66bc8f3cbc9926372af67101df4e0ecc94b5d03d41- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT00262600.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
-
Claim, not a settled fact Compared with warfarin in RE-LY: Atrial fibrillation (AF)
Applies to Adult- People with non-valvular atrial fibrillation at moderate to high risk of stroke, or systemic embolism, with at least one additional risk factor: previous ischemic stroke, transient ischemic attack or systemic embolism, left ventricular dysfunction, age 75 or older, or age 65 or older with diabetes, coronary artery disease or hypertension (registry wording).
- Not stated in the abstract or the registry record
- International (the registry lists sites in many countries; they are recorded on the study)
- Adults aged 18 or older (registry minimum age)
In RE-LY, a noninferiority trial, 18,113 patients with atrial fibrillation and a risk of stroke were randomly assigned to fixed doses of dabigatran, 110 mg or 150 mg twice daily, given in a blinded fashion, or to adjusted-dose warfarin, given unblinded. The median follow-up was 2.0 years. The primary outcome, stroke or systemic embolism, occurred at 1.69% per year with warfarin, 1.53% per year with 110 mg of dabigatran (relative risk 0.91, 95% confidence interval 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year with 150 mg of dabigatran (relative risk 0.66, 95% CI 0.53 to 0.82; P<0.001 for superiority). Major bleeding occurred at 3.36% per year with warfarin, 2.71% per year with 110 mg of dabigatran (P=0.003) and 3.11% per year with 150 mg of dabigatran (P=0.31, no significant difference from warfarin). Hemorrhagic stroke occurred at 0.38% per year with warfarin, 0.12% with 110 mg and 0.10% with 150 mg (each P<0.001). The mortality rate was 4.13% per year with warfarin, 3.75% with 110 mg (P=0.13) and 3.64% with 150 mg (P=0.051).Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. Abstract of the main report only. The warfarin arm was unblinded, and the abstract does not say what the registry or the full text say about adjudication. PubMed links a published erratum to the paper (N Engl J Med 2010 Nov 4;363(19):1877); what it changes was not read, so the numbers here may not match the corrected paper. The abstract and the registry both give 18,113 participants. The registry arms are labeled dose 1 and dose 2 without milligram values, and the doses are taken from the abstract. Dabigatran at 150 mg twice daily had major bleeding similar to warfarin, and mortality did not differ significantly for either dose.
Record details
- Record id
cardio:dabigatran- Content hash
9c235e04af4f2651a7ac91b288cc3b5b12c8963221869bf10b480dd0db07f365