{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:apixaban", "owner": "cardio", "kind": "drug", "slug": "apixaban", "name": "Apixaban", "aliases": [], "atlases": [ "cardio" ], "summary_plain": "The medicine inside Eliquis. It is a blood thinner taken by mouth. In the ARISTOTLE trial it was compared with warfarin in people with atrial fibrillation at higher risk of stroke, and the authors report it was superior to warfarin for stroke or clots elsewhere in the body, caused less major bleeding and was linked with lower death from any cause.", "summary_technical": "RxNorm ingredient 1364430. A factor Xa inhibitor (ARISTOTLE abstract). Tested against warfarin in ARISTOTLE (claim cardio:claim-aristotle-apixaban-vs-warfarin); brand name Eliquis in the US regulator's record (NDA 202155). 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": "1364430", "normalized_value": "1364430", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "arrhythmias", "stroke" ] } }, "payload": { "level": "substance", "mechanism": "An oral direct factor Xa inhibitor (ARISTOTLE abstract)." }, "content_digest": "ecb59c5099d85b5169fc795b69526e7b2bbb8138cf32f1b30c99f65df47c4c2f", "review": { "content_digest": "ecb59c5099d85b5169fc795b69526e7b2bbb8138cf32f1b30c99f65df47c4c2f", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-aristotle-apixaban-vs-warfarin", "owner": "cardio", "subject_entity_id": "cardio:apixaban", "category": "effect", "statement": "In ARISTOTLE, a randomized, double-blind trial, apixaban (5 mg twice daily) was compared with warfarin (target international normalized ratio 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke, with a median follow-up of 1.8 years. The primary outcome, ischemic or hemorrhagic stroke or systemic embolism, occurred at 1.27% per year with apixaban and 1.60% per year with warfarin (hazard ratio 0.79, 95% confidence interval 0.66 to 0.95; P<0.001 for noninferiority, P=0.01 for superiority). Major bleeding occurred at 2.13% per year with apixaban and 3.09% per year with warfarin (hazard ratio 0.69, 95% CI 0.60 to 0.80; P<0.001). The rates of death from any cause were 3.52% with apixaban and 3.94% with warfarin (hazard ratio 0.89, 95% CI 0.80 to 0.99; P=0.047). Hemorrhagic stroke occurred at 0.24% per year with apixaban and 0.47% per year with warfarin (hazard ratio 0.51, 95% CI 0.35 to 0.75; P<0.001). Ischemic or uncertain-type stroke occurred at 0.97% per year with apixaban and 1.05% per year with warfarin (hazard ratio 0.92, 95% CI 0.74 to 1.13; P=0.42), a difference that was not statistically significant.", "context": { "id": "cardio:ctx-aristotle-af-and-stroke-risk-factor", "label": "Adults with atrial fibrillation and at least one additional risk factor for stroke (ARISTOTLE)", "recipient": "adult", "population": "Patients aged 18 or older with atrial fibrillation and at least one additional risk factor for stroke: age 75 or older, previous stroke, transient ischemic attack or systemic embolism, symptomatic heart failure or reduced left ventricular function, or diabetes or hypertension requiring drug treatment (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 inclusion text)", "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 1.8 years (abstract).", "eligibility": { "inclusion": [ "Aged 18 years or older, with atrial fibrillation", "At least one more stroke risk factor: age 75 or older, previous stroke, transient ischemic attack or systemic embolism, symptomatic heart failure or left ventricular ejection fraction of 40% or less, or diabetes or hypertension requiring drug treatment" ], "exclusion": [ "Not stated in the registry record" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Abstract of the main report; the full text, the supplement and the registry results tables were not read. The paper and the registry give different participant counts: the abstract says 18,201 patients and the registry enrollment is 20976, and the difference is not explained or reconciled here. The abstract names the 5 mg twice-daily dose; the registry lists 5.0 mg or 2.5 mg twice daily. The trial population had at least one additional stroke risk factor, so results do not apply to every person with atrial fibrillation. The conclusion in the abstract is the authors' reading, with funding by Bristol-Myers Squibb and Pfizer.", "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 doses (first fragment).", "snapshot": { "id": "cardio:pubmed-21870978-2026-10-14", "retrieved_at": "2026-10-14T18:18:38Z", "content_hash": "070808b131231dc9141645fc51ed733ed3f8db0ad34099cce02d8c66b19843ba", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:aristotle-nejm-2011", "source_type": "publication", "title": "Apixaban versus warfarin in patients with atrial fibrillation", "canonical_url": "https://doi.org/10.1056/NEJMoa1107039", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1107039", "normalized_value": "10.1056/nejmoa1107039", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "21870978", "normalized_value": "21870978", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2011-09-15", "publisher": "Journal record via PubMed (N Engl J Med 2011;365(11):981-92)", "edition": "PubMed record (abstract and bibliographic data) fetched 2026-10-14 through NCBI E-utilities. 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