{"id":"fb746b359b72","type":"article","url":"https://hartvaat.nl/2022/10/11/langetermijn-evolocumab-bij-atherosclerotisch-vaatlijden-open-label-extensie-fou/","title":"Langetermijn evolocumab bij atherosclerotisch vaatlijden: open-label extensie FOURIER","title_en":"Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["atherosclerose","bempedoïnezuur","cetp-remmers","dyslipidemie","ezetimibe","familiaire-hypercholesterolemie-screening","gedilateerde-cardiomyopathie","ldl-cholesterol","lipidenverlaging","niet-statine-therapie","pcsk9-remmers","pelacarsen","perifeer-vaatlijden","plaquekarakterisatie","statines","vrouwen","yellow-iii"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.122.061620","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.122.061620","authors":["Michelle L O'Donoghue","Robert P Giugliano","Stephen D Wiviott","Dan Atar","Anthony Keech","Julia F Kuder","KyungAh Im","Sabina A Murphy","Jose H Flores-Arredondo","J Antonio G López","Mary Elliott-Davey","Bei Wang","Maria Laura Monsalvo","Siddique Abbasi","Marc S Sabatine"],"significance":7,"published":"2022-10-11","source_date":"2022-10-11","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/ldl-cholesterol-mechanisme/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"The open-label FOURIER extension showed that long-term evolocumab use (up to 5 years) maintains sustained LDL cholesterol reduction with a favorable safety profile, providing the longest-term safety data for PCSK9 monoclonal antibody therapy.","created":"2026-07-03T10:30:00Z","updated":"2026-07-03T13:29:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Open-label extensie van FOURIER toonde dat langetermijn evolocumab-gebruik (tot 5 jaar) veilig was en het LDL-cholesterol duurzaam verlaagde. Het cardiovasculaire voordeel bleef behouden zonder nieuwe veiligheidssignalen, wat langdurige PCSK9-remming ondersteunt.","abstract_original":"BACKGROUND: In FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk), the proprotein convertase subtilisin-kexin type 9 inhibitor evolocumab reduced low-density lipoprotein cholesterol (LDL-C) and risk of cardiovascular events and was safe and well tolerated over a median of 2.2 years of follow-up. However, large-scale, long-term data are lacking. METHODS: The parent FOURIER trial randomized 27 564 patients with atherosclerotic cardiovascular disease and LDL-C ≥70 mg/dL on statin to evolocumab versus placebo. Patients completing FOURIER at participating sites were eligible to receive evolocumab in 2 open-label extension studies (FOURIER-OLE [FOURIER Open-Label Extension]) in the United States and Europe; primary analyses were pooled across studies. The primary end point was the incidence of adverse events. Lipid values and major adverse cardiovascular events were prospectively collected. RESULTS: A total of 6635 patients were enrolled in FOURIER-OLE (3355 randomized to evolocumab and 3280 to placebo in the parent study). Median follow-up in FOURIER-OLE was 5.0 years; maximum exposure to evolocumab in parent plus FOURIER-OLE was 8.4 years. At 12 weeks in FOURIER-OLE, median LDL-C was 30 mg/dL, and 63.2% of patients achieved LDL-C <40 mg/dL on evolocumab. Incidences of serious adverse events, muscle-related events, new-onset diabetes, hemorrhagic stroke, and neurocognitive events with evolocumab long term did not exceed those for placebo-treated patients during the parent study and did not increase over time. During the FOURIER-OLE follow-up period, patients originally randomized in the parent trial to evolocumab versus placebo had a 15% lower risk of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina or coronary revascularization (hazard ratio, 0.85 [95% CI, 0.75-0.96]; P=0.008); a 20% lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80 [95% CI, 0.68-0.93]; P=0.003); and a 23% lower risk of cardiovascular death (hazard ratio, 0.77 [95% CI, 0.60-0.99]; P=0.04). CONCLUSIONS: Long-term LDL-C lowering with evolocumab was associated with persistently low rates of adverse events for >8 years that did not exceed those observed in the original placebo arm during the parent study and led to further reductions in cardiovascular events compared with delayed treatment initiation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT02867813 and NCT03080935."}