# Dabigatran Drug · id `cardio:dabigatran` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, condition area: Stroke; Heart rhythm problems ## In plain language 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. ## 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 US regulator's record (NDA 022512), where the openFDA active ingredient is dabigatran etexilate mesylate. The numbers are on the claim. ## Claims, with the population each applies to ## 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). ### 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). - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - 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 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Design and patient count (first fragment). 2. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Doses and comparator (second fragment). 3. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Median follow-up. 4. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, METHODS, sentence 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Primary outcome. 5. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Primary outcome with warfarin. 6. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Primary outcome with 110 mg. 7. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 1, fragment 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Primary outcome with 150 mg. 8. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 1, fragment 4. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Superiority interval for 150 mg. 9. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 2, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Major bleeding with warfarin. 10. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Major bleeding with 110 mg. 11. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 2, fragment 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Major bleeding with 150 mg. 12. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 3, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Hemorrhagic stroke with warfarin. 13. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 3, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Hemorrhagic stroke with dabigatran. 14. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 4, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Mortality with warfarin and 110 mg. 15. Supports: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, RESULTS, sentence 4, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Mortality with 150 mg. 16. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, CONCLUSIONS, sentence 1, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: The authors' conclusion for 110 mg (first fragment). 17. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, CONCLUSIONS, sentence 1, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: The authors' conclusion for 110 mg (second fragment). 18. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, CONCLUSIONS, sentence 2, fragment 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: The authors' conclusion for 150 mg (first fragment). 19. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, CONCLUSIONS, sentence 2, fragment 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: The authors' conclusion for 150 mg (second fragment). 20. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: Abstract, BACKGROUND, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: Dabigatran is an oral direct thrombin inhibitor. 21. Background: Newly identified events in the RE-LY trial (Publication, edition PubMed record (title and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. It is a letter that PubMed lists as a comment on the RE-LY paper; its text was not read.) Locator: PubMed record of PMID 21047252, ArticleTitle. Retrieved 2026-10-14T19:20:00Z. Source state: Current. Snapshot hash: 68370e0f1cd169d507461b8679e7a57049bc13b44a4bc9244e7a4886063c9e2e. 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. 22. Background: Dabigatran versus warfarin in patients with atrial fibrillation (Publication, edition PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. No PMC copy is listed. The full text and the version of record were not fetched. PubMed links a published erratum (N Engl J Med 2010 Nov 4;363(19):1877) that was not read, so the source state is corrected.) Locator: PubMed record, CommentsCorrections (ErratumIn). Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961. How it applies: PubMed links a published erratum whose content was not read. 23. Background: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate (Registry, edition ClinicalTrials.gov API v2 record fetched 2026-10-14. Last update posted 2011-02-10.) Locator: protocolSection.designModule.enrollmentInfo.count. Retrieved 2026-10-14T18:18:34Z. Source state: Current. Snapshot hash: 154435b06ce58ac9fb39bc66bc8f3cbc9926372af67101df4e0ecc94b5d03d41. How it applies: Registry enrollment count, equal to the abstract. ## Connected pages - Compared with warfarin in RE-LY: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`) [a claim, not a settled fact; see claim `cardio:claim-re-ly-dabigatran-vs-warfarin` and its context] - A direct oral anticoagulant used for this strategy: Blood thinners (oral anticoagulants) to prevent stroke in AF (`cardio:oral-anticoagulation`) - Filed under this front: Medicines (`cardio:front-medicines`) - Contained in: Dabigatran (Pradaxa) (`cardio:pradaxa`) - Investigated in: RE-LY (`cardio:re-ly`) ## Provenance Content hash: 13c764ca80b03a22a4e7dc4a6ea5f1ab40b4162c5cc6b5d4e402d77c97cfb4f1 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-14