{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:dabigatran", "owner": "cardio", "kind": "drug", "slug": "dabigatran", "name": "Dabigatran", "aliases": [], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "1546356", "normalized_value": "1546356", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "arrhythmias", "stroke" ] } }, "payload": { "level": "substance", "mechanism": "An oral direct thrombin inhibitor (RE-LY abstract)." }, "content_digest": "13c764ca80b03a22a4e7dc4a6ea5f1ab40b4162c5cc6b5d4e402d77c97cfb4f1", "review": { "content_digest": "13c764ca80b03a22a4e7dc4a6ea5f1ab40b4162c5cc6b5d4e402d77c97cfb4f1", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-re-ly-dabigatran-vs-warfarin", "owner": "cardio", "subject_entity_id": "cardio:dabigatran", "category": "effect", "statement": "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).", "context": { "id": "cardio:ctx-re-ly-af-and-risk-of-stroke", "label": "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_note": "Adults aged 18 or older (registry minimum age)", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Median follow-up of 2.0 years (abstract).", "eligibility": { "inclusion": [ "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" ], "exclusion": [ "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" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 1, fragment 1", "applicability_note": "Design and patient count (first fragment).", "snapshot": { "id": "cardio:pubmed-19717844-2026-10-14", "retrieved_at": "2026-10-14T18:18:39Z", "content_hash": "aaacb0274d782286896b45793761b0f4704804c766ceb3bd6d9942d5cb0aa961", "source_effective_date": null, "public_archive_url": null, "source_state": "corrected" }, "source": { "id": "cardio:re-ly-nejm-2009", "source_type": "publication", "title": "Dabigatran versus warfarin in patients with atrial fibrillation", "canonical_url": "https://doi.org/10.1056/NEJMoa0905561", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa0905561", "normalized_value": "10.1056/nejmoa0905561", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "19717844", "normalized_value": "19717844", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2009-09-17", "publisher": "Journal record via PubMed (N Engl J Med 2009;361(12):1139-51)", "edition": "PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. 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