{"id":"8816a2a1b291","type":"article","url":"https://hartvaat.nl/2022/07/30/matige-statine-plus-ezetimibe-versus-hoge-dosis-statine-bij-coronairlijden-lance/","title":"Matige statine plus ezetimibe versus hoge-dosis statine bij coronairlijden: Lancet-studie","title_en":"Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial.","category":"cholesterol","category_label":"Cholesterol","professions":["apotheker","cardioloog","internist"],"tags":["statines"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(22)00916-3","source_url":"https://doi.org/10.1016/S0140-6736(22)00916-3","authors":["Byeong-Keuk Kim","Sung-Jin Hong","Yong-Joon Lee","Soon Jun Hong","Kyeong Ho Yun","Bum-Kee Hong","Jung Ho Heo","Seung-Woon Rha","Yun-Hyeong Cho","Seung-Jun Lee","Chul-Min Ahn","Jung-Sun Kim","Young-Guk Ko","Donghoon Choi","Yangsoo Jang","Myeong-Ki Hong"],"significance":8,"published":"2022-07-30","source_date":"2022-07-30","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/lipiden/ezetimib/"],"congress":"","summary_en":"This Lancet long-term study demonstrated that moderate-intensity statin combined with ezetimibe was equally effective as high-intensity statin monotherapy for preventing cardiovascular events, with fewer adverse effects. The results supported combination therapy as an alternative to high-dose statins.","created":"2026-07-03T10:29:51Z","updated":"2026-07-03T13:28:57Z","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":"Langetermijnstudie in de Lancet toonde dat matige-intensiteit statine met ezetimibe even effectief was als hoge-dosis statine monotherapie bij patiënten na PCI, met minder bijwerkingen. Combinatietherapie kan de therapietrouw verbeteren door een gunstiger bijwerkingenprofiel.","abstract_original":"BACKGROUND: Drug combinations rather than increasing doses of one drug can achieve greater efficacy and lower risks. Thus, as an alternative to high-intensity statin monotherapy, moderate-intensity statin with ezetimibe combination therapy can lower LDL cholesterol concentrations effectively while reducing adverse effects. However, evidence from randomised trials to compare long-term clinical outcomes is needed. METHODS: In this randomised, open-label, non-inferiority trial, patients with atherosclerotic cardiovascular disease (ASCVD) at 26 clinical centres in South Korea were randomly assigned (1:1) to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint was the 3-year composite of cardiovascular death, major cardiovascular events, or non-fatal stroke, in the intention-to-treat population with a non-inferiority margin of 2·0%. This trial is registered with ClinicalTrials.gov, NCT03044665 and is complete. FINDINGS: Between Feb 14, 2017, and Dec 18, 2018, 3780 patients were enrolled: 1894 patients to the combination therapy group and 1886 to the high-intensity statin monotherapy group. The primary endpoint occurred in 172 patients (9·1%) in the combination therapy group and 186 patients (9·9%) in the high-intensity statin monotherapy group (absolute difference -0·78%; 90% CI -2·39 to 0·83). LDL cholesterol concentrations of less than 70 mg/dL at 1, 2, and 3 years were observed in 73%, 75%, and 72% of patients in the combination therapy group, and 55%, 60%, and 58% of patients in the high-intensity statin monotherapy group (all p<0·0001). Discontinuation or dose reduction of the study drug by intolerance was observed in 88 patients (4·8%) and 150 patients (8·2%), respectively (p<0·0001). INTERPRETATION: Among patients with ASCVD, moderate-intensity statin with ezetimibe combination therapy was non-inferior to high-intensity statin monotherapy for the 3-year composite outcomes with a higher proportion of patients with LDL cholesterol concentrations of less than 70 mg/dL and lower intolerance-related drug discontinuation or dose reduction. FUNDING: Hanmi Pharmaceutical."}