{"id":"85630fd7f53b","type":"article","url":"https://hartvaat.nl/2023/09/01/matige-statine-plus-ezetimibe-bij-zeer-hoog-ascvd-risico-non-inferioriteitstudie/","title":"Matige statine plus ezetimibe bij zeer hoog ASCVD-risico: non-inferioriteitstudie","title_en":"Moderate-Intensity Statin With Ezetimibe Combination Therapy vs High-Intensity Statin Monotherapy in Patients at Very High Risk of Atherosclerotic Cardiovascular Disease: A Post Hoc Analysis From the RACING Randomized Clinical Trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["ezetimibe","niet-statine-therapie"],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2023.2222","source_url":"https://doi.org/10.1001/jamacardio.2023.2222","authors":["Seung-Jun Lee","Jung-Joon Cha","Woong Gil Choi","Wang-Soo Lee","Jin-Ok Jeong","Seonghoon Choi","Yoon-Haeng Cho","Woojung Park","Chang-Hwan Yoon","Yong-Joon Lee","Sung-Jin Hong","Chul-Min Ahn","Byeong-Keuk Kim","Young-Guk Ko","Donghoon Choi","Myeong-Ki Hong","Yangsoo Jang","Soon Jun Hong","Jung-Sun Kim"],"significance":7,"published":"2023-09-01","source_date":"2023-09-01","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/lipidenmedicatie-bij-ckd/"],"congress":"","summary_en":"This study confirmed that moderate-intensity statin with ezetimibe is noninferior to high-intensity statin in patients at very high cardiovascular risk, extending the combination therapy evidence to the highest-risk population.","created":"2026-07-03T10:30:33Z","updated":"2026-07-03T13:29:36Z","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":"Studie bevestigde dat matige-intensiteit statine met ezetimibe non-inferieur was aan hoge-dosis statine bij patiënten met zeer hoog ASCVD-risico. De bevindingen zijn consistent met eerdere data en ondersteunen combinatietherapie als alternatief.","abstract_original":"IMPORTANCE: High-intensity statin is strongly recommended in patients at very high risk (VHR) of atherosclerotic cardiovascular disease (ASCVD). However, concerns about statin-associated adverse effects result in underuse of this strategy in practice. OBJECTIVE: To evaluate the outcomes of a moderate-intensity statin with ezetimibe combination in VHR and non-VHR patients with ASCVD. DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the Randomized Comparison of Efficacy and Safety of Lipid Lowering With Statin Monotherapy vs Statin/Ezetimibe Combination for High-Risk Cardiovascular Disease (RACING) open-label, multicenter, randomized clinical trial. The study was conducted from February 2017 to December 2018 at 26 centers in Korea. Study participants included patients with documented ASCVD. Data were analyzed from April to June 2022. INTERVENTIONS: Patients were randomly assigned to moderate-intensity statin with ezetimibe (rosuvastatin, 10 mg, with ezetimibe, 10 mg) or high-intensity statin monotherapy (rosuvastatin, 20 mg). Patients at VHR for ASCVD were defined according to the 2018 American Heart Association/American College of Cardiology guidelines. MAIN OUTCOMES AND MEASURES: The primary end point was the 3-year outcome of cardiovascular death, coronary or peripheral revascularization, hospitalization of cardiovascular events, or nonfatal stroke. RESULTS: A total of 3780 patients (mean [SD] age, 64 [10] years; 2826 male [75%]) in the RACING trial, 1511 (40.0%) were categorized as VHR, which was associated with a greater occurrence of the primary end point (hazard ratio [HR], 1.42; 95% CI, 1.15-1.75). There was no significant difference in the primary end point between those who received combination therapy and high-intensity statin monotherapy among patients with VHR disease (11.2% vs 11.7%; HR, 0.96; 95% CI, 0.71-1.30) and non-VHR disease (7.7% vs 8.7%; HR, 0.88; 95% CI, 0.66-1.18). The median low-density lipoprotein cholesterol (LDL-C) level was significantly lower in the combination therapy group than in the high-intensity statin group (VHR, 1 year: 57 [47-71] mg/dL vs 65 [53-78] mg/dL; non-VHR, 1 year: 58 mg/dL vs 68 mg/dL; P < .001). Furthermore, in both the VHR and non-VHR groups, combination therapy was associated with a significantly greater mean change in LDL-C level (VHR, 1 year: -19.1 mg/dL vs -10.1 mg/dL; 2 years: -22.3 mg/dL vs -13.0 mg/dL; 3 years: -18.8 mg/dL vs -9.7 mg/dL; non-VHR, 1 year: -23.7 mg/dL vs -12.5 mg/dL; 2 years: -25.2 mg/dL vs -15.1 mg/dL; 3 years: -23.5 mg/dL vs -12.6 mg/dL; all P < .001) and proportion of patients with LDL-C level less than 70 mg/dL (VHR, 1 year: 73% vs 58%; non-VHR, 1 year: 72% vs 53%; P < .001). Discontinuation or dose reduction of the lipid-lowering drug due to intolerance occurred less frequently in the combination therapy group (VHR, 4.6% vs 7.7%; P = .02; non-VHR, 5.0% vs 8.7%; P = .001). CONCLUSIONS AND RELEVANCE: Results suggest that the outcomes of ezetimibe combination observed in the RACING trial were consistent among patients at VHR of ASCVD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03044665."}