Cited 21 times in
Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial
DC Field | Value | Language |
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dc.contributor.author | 고영국 | - |
dc.contributor.author | 김병극 | - |
dc.contributor.author | 김중선 | - |
dc.contributor.author | 안철민 | - |
dc.contributor.author | 유승찬 | - |
dc.contributor.author | 이승준 | - |
dc.contributor.author | 이용준 | - |
dc.contributor.author | 이용호 | - |
dc.contributor.author | 최동훈 | - |
dc.contributor.author | 홍명기 | - |
dc.contributor.author | 홍성진 | - |
dc.date.accessioned | 2023-04-20T08:20:54Z | - |
dc.date.available | 2023-04-20T08:20:54Z | - |
dc.date.issued | 2023-03 | - |
dc.identifier.issn | 0195-668X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/194074 | - |
dc.description.abstract | Importance: In phase 2 studies, evolocumab, a fully human monoclonal antibody to PCSK9, reduced LDL-C levels in patients receiving statin therapy. Objective: To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Design, setting, and patients: Phase 3, 12-week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries. Interventions: Patients (n = 2067) were randomized to 1 of 24 treatment groups in 2 steps. Patients were initially randomized to a daily, moderate-intensity (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or high-intensity (atorvastatin [80 mg], rosuvastatin [40 mg]) statin. After a 4-week lipid-stabilization period, patients (n = 1899) were randomized to compare evolocumab (140 mg every 2 weeks or 420 mg monthly) with placebo (every 2 weeks or monthly) or ezetimibe (10 mg or placebo daily; atorvastatin patients only) when added to statin therapies. Main outcomes and measures: Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) level at the mean of weeks 10 and 12 and at week 12. Results: Evolocumab reduced LDL-C levels by 66% (95% CI, 58% to 73%) to 75% (95% CI, 65% to 84%) (every 2 weeks) and by 63% (95% CI, 54% to 71%) to 75% (95% CI, 67% to 83%) (monthly) vs placebo at the mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups; the LDL-C reductions at week 12 were comparable. For moderate-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL. For high-intensity statin groups, evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL. Adverse events were reported in 36%, 40%, and 39% of evolocumab-, ezetimibe-, and placebo-treated patients, respectively. The most common adverse events in evolocumab-treated patients were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all <2%). Conclusions and relevance: In this 12-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering. Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Oxford University Press | - |
dc.relation.isPartOf | EUROPEAN HEART JOURNAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Anticholesteremic Agents* / adverse effects | - |
dc.subject.MESH | Atherosclerosis* / drug therapy | - |
dc.subject.MESH | Atherosclerosis* / prevention & control | - |
dc.subject.MESH | Cardiovascular Diseases* / drug therapy | - |
dc.subject.MESH | Cholesterol, LDL | - |
dc.subject.MESH | Diabetes Mellitus* / drug therapy | - |
dc.subject.MESH | Diabetes Mellitus* / epidemiology | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Ezetimibe / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Yong-Joon Lee | - |
dc.contributor.googleauthor | Jae Young Cho | - |
dc.contributor.googleauthor | Seng Chan You | - |
dc.contributor.googleauthor | Yong-Ho Lee | - |
dc.contributor.googleauthor | Kyeong Ho Yun | - |
dc.contributor.googleauthor | Yun-Hyeong Cho | - |
dc.contributor.googleauthor | Won-Yong Shin | - |
dc.contributor.googleauthor | Sang Wook Im | - |
dc.contributor.googleauthor | Woong Chol Kang | - |
dc.contributor.googleauthor | Yongwhi Park | - |
dc.contributor.googleauthor | Sung Yoon Lee | - |
dc.contributor.googleauthor | Seung-Jun Lee | - |
dc.contributor.googleauthor | Sung-Jin Hong | - |
dc.contributor.googleauthor | Chul-Min Ahn | - |
dc.contributor.googleauthor | Byeong-Keuk Kim | - |
dc.contributor.googleauthor | Young-Guk Ko | - |
dc.contributor.googleauthor | Donghoon Choi | - |
dc.contributor.googleauthor | Myeong-Ki Hong | - |
dc.contributor.googleauthor | Yangsoo Jang | - |
dc.contributor.googleauthor | Jung-Sun Kim | - |
dc.identifier.doi | 10.1093/eurheartj/ehac709 | - |
dc.contributor.localId | A00127 | - |
dc.contributor.localId | A00493 | - |
dc.contributor.localId | A00961 | - |
dc.contributor.localId | A02269 | - |
dc.contributor.localId | A02478 | - |
dc.contributor.localId | A02927 | - |
dc.contributor.localId | A02984 | - |
dc.contributor.localId | A02989 | - |
dc.contributor.localId | A04053 | - |
dc.contributor.localId | A04391 | - |
dc.contributor.localId | A04403 | - |
dc.relation.journalcode | J00805 | - |
dc.identifier.eissn | 1522-9645 | - |
dc.identifier.pmid | 36529993 | - |
dc.identifier.url | https://academic.oup.com/eurheartj/article/44/11/972/6931821 | - |
dc.subject.keyword | Atherosclerotic cardiovascular disease | - |
dc.subject.keyword | Diabetes mellitus | - |
dc.subject.keyword | Ezetimibe | - |
dc.subject.keyword | Statin | - |
dc.contributor.alternativeName | Ko, Young Guk | - |
dc.contributor.affiliatedAuthor | 고영국 | - |
dc.contributor.affiliatedAuthor | 김병극 | - |
dc.contributor.affiliatedAuthor | 김중선 | - |
dc.contributor.affiliatedAuthor | 안철민 | - |
dc.contributor.affiliatedAuthor | 유승찬 | - |
dc.contributor.affiliatedAuthor | 이승준 | - |
dc.contributor.affiliatedAuthor | 이용준 | - |
dc.contributor.affiliatedAuthor | 이용호 | - |
dc.contributor.affiliatedAuthor | 최동훈 | - |
dc.contributor.affiliatedAuthor | 홍명기 | - |
dc.contributor.affiliatedAuthor | 홍성진 | - |
dc.citation.volume | 44 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 972 | - |
dc.citation.endPage | 983 | - |
dc.identifier.bibliographicCitation | EUROPEAN HEART JOURNAL, Vol.44(11) : 972-983, 2023-03 | - |
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