{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:evolocumab", "owner": "cardio", "kind": "drug", "slug": "evolocumab", "name": "Evolocumab", "aliases": [ "AMG 145" ], "atlases": [ "cardio" ], "summary_plain": "Evolocumab is an antibody, given by injection, that blocks the PCSK9 protein and lowers LDL cholesterol by about 60% in the FOURIER abstract. In FOURIER it reduced heart and blood-vessel events in people with cardiovascular disease who already took a statin.", "summary_technical": "RxNorm ingredient 1665684. Human monoclonal IgG2 directed against PCSK9 per the US drug label. Brand product: Repatha. Outcomes evidence: FOURIER.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "1665684", "normalized_value": "1665684", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "condition-area": [ "coronary-and-vascular-disease" ] } }, "payload": { "level": "substance", "mechanism": "Monoclonal antibody that inhibits PCSK9, so more LDL receptors are available to clear LDL from the blood (US drug label)" }, "content_digest": "fb1d96d60146d1b181530606902580ee67a69db863c2cbcae5f7d9d6dec066e7", "review": { "content_digest": "fb1d96d60146d1b181530606902580ee67a69db863c2cbcae5f7d9d6dec066e7", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-fourier-evolocumab-cardiovascular-events", "owner": "cardio", "subject_entity_id": "cardio:evolocumab", "category": "effect", "statement": "In FOURIER, 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL or higher on statin therapy received evolocumab or placebo by injection. At 48 weeks the LDL cholesterol was 59% lower with evolocumab than with placebo, to a median of 30 mg/dL. The primary composite end point occurred in 1344 patients (9.8%) on evolocumab and 1563 (11.3%) on placebo (hazard ratio 0.85, 95% CI 0.79 to 0.92). The key secondary composite occurred in 816 (5.9%) and 1013 (7.4%) (hazard ratio 0.80, 95% CI 0.73 to 0.88). The abstract reports no significant difference in adverse events except injection-site reactions, more common with evolocumab (2.1% against 1.6%).", "context": { "id": "cardio:ctx-fourier-ascvd-on-statin-adults", "label": "Adults aged 40 to 85 with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg/dL or higher on statin therapy (FOURIER)", "recipient": "adult", "population": "Patients with atherosclerotic cardiovascular disease and LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy (abstract). The registry gives ages 40 to 85 years and all sexes.", "care_setting": "Multicentre outpatient trial (abstract); site list not read", "geography": "Multinational: the study record lists every country the registry names", "life_stage_note": "Adult, 40 to 85 years (registry)", "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 2.2 years (abstract).", "eligibility": { "inclusion": [ "Atherosclerotic cardiovascular disease", "LDL cholesterol of 70 mg per deciliter (1.8 mmol per liter) or higher on statin therapy (abstract)" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One randomised, double-blind, placebo-controlled trial with a median follow-up of 2.2 years, funded by Amgen according to the abstract. The population is defined by atherosclerotic cardiovascular disease, which is wider than coronary artery disease. 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