{"id":"df8b61fc43fc","type":"article","url":"https://hartvaat.nl/2019/10/29/langetermijn-werkzaamheid-en-veiligheid-van-evolocumab-bij-hypercholesterolemie/","title":"Langetermijn werkzaamheid en veiligheid van evolocumab bij hypercholesterolemie","title_en":"Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["bempedoïnezuur","cetp-remmers","diabetes-en-hart","dyslipidemie","ezetimibe","familiaire-hypercholesterolemie","familiaire-hypercholesterolemie-screening","hdl-cholesterol","hypertrofische-cardiomyopathie","laminopathie","ldl-cholesterol","lipide-aferese","lipidenverlaging","niet-statine-therapie","pcsk9-remmers","pelacarsen","plaquekarakterisatie","rosuvastatine","statines","vrouwen","yellow-iii"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2019.08.1024","source_url":"https://doi.org/10.1016/j.jacc.2019.08.1024","authors":["Michael J Koren","Marc S Sabatine","Robert P Giugliano","Gisle Langslet","Stephen D Wiviott","Andrea Ruzza","Yuhui Ma","Andrew W Hamer","Scott M Wasserman","Frederick J Raal"],"significance":7,"published":"2019-10-29","source_date":"2019-10-29","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/"],"congress":"","summary_en":"This long-term analysis confirmed that evolocumab maintains consistent LDL cholesterol lowering and cardiovascular event reduction over extended follow-up periods, with no attenuation of efficacy or emergence of late safety signals.","created":"2026-07-03T10:28:13Z","updated":"2026-07-03T13:27:24Z","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":"Langetermijnanalyse van werkzaamheid en veiligheid van evolocumab bij patiënten met hypercholesterolemie. Bevestigt duurzame LDL-verlaging zonder veiligheidssignalen.","abstract_original":"BACKGROUND: Evolocumab and other anti-PCSK9 antibodies reduced adverse cardiovascular outcomes in clinical trials of high-risk patients over <3 years median treatment duration. OBJECTIVES: The OSLER-1 trial (Open Label Study of Long Term Evaluation Against LDL-C Trial) evaluated longer-term effects of evolocumab during open-label hypercholesterolemia treatment for up to 5 years. METHODS: Patients randomized to standard of care (SOC) or evolocumab 420 mg monthly (evolocumab + SOC) for year 1. After year 1, patients could enter the all-evolocumab period and receive evolocumab + SOC for an additional 4 years. The authors analyzed the persistence of lipid effects and exposure-dependent safety focusing on yearly rates of adverse events (AEs) and anti-drug antibodies over 4.951 patient-years of observation. RESULTS: A total of 1,255 patients (safety analysis population) randomized into the year 1 SOC-controlled period and received ≥1 evolocumab dose (mean ± SD age 57 ± 12 years; 53% female). A total of 1,151 patients (efficacy analysis population) progressed to the all-evolocumab period (year 2 and beyond). Evolocumab + SOC persistently lowered mean ± SE low-density lipoprotein cholesterol (LDL-C) by 56% ± 0.6% (n = 1,071), 57% ± 0.8% (n = 1,001), 56% ± 0.8% (n = 943), and 56% ± 0.8% (n = 803) after approximately 2, 3, 4, and 5 years, respectively, from randomization. Mean baseline LDL-C decreased from 140 to 61 mg/dl on treatment. Yearly serious AE rates during evolocumab + SOC ranged from 6.9% to 7.9%, comparable to the 6.8% rate in SOC patients during year 1. Evolocumab discontinuation due to AEs occurred in 5.7% of patients. Two SOC and 2 evolocumab + SOC patients developed new, transient, binding anti-drug antibodies; no neutralizing antibodies were observed. CONCLUSIONS: The OSLER-1 trial demonstrated consistently excellent LDL-C-lowering efficacy, tolerance, and safety of evolocumab, with no neutralizing antibodies detected, throughout the longest-duration study of a PCSK9 inhibitor reported to date. (Open Label Study of Long Term Evaluation Against LDL-C Trial [OSLER-1]; NCT01439880)."}