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Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial

Authors
 Yong-Joon Lee  ;  Jae Young Cho  ;  Seng Chan You  ;  Yong-Ho Lee  ;  Kyeong Ho Yun  ;  Yun-Hyeong Cho  ;  Won-Yong Shin  ;  Sang Wook Im  ;  Woong Chol Kang  ;  Yongwhi Park  ;  Sung Yoon Lee  ;  Seung-Jun Lee  ;  Sung-Jin Hong  ;  Chul-Min Ahn  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Myeong-Ki Hong  ;  Yangsoo Jang  ;  Jung-Sun Kim 
Citation
 EUROPEAN HEART JOURNAL, Vol.44(11) : 972-983, 2023-03 
Journal Title
EUROPEAN HEART JOURNAL
ISSN
 0195-668X 
Issue Date
2023-03
MeSH
Anticholesteremic Agents* / adverse effects ; Atherosclerosis* / drug therapy ; Atherosclerosis* / prevention & control ; Cardiovascular Diseases* / drug therapy ; Cholesterol, LDL ; Diabetes Mellitus* / drug therapy ; Diabetes Mellitus* / epidemiology ; Drug Therapy, Combination ; Ezetimibe / therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects ; Treatment Outcome
Keywords
Atherosclerotic cardiovascular disease ; Diabetes mellitus ; Ezetimibe ; Statin
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.
Full Text
https://academic.oup.com/eurheartj/article/44/11/972/6931821
DOI
10.1093/eurheartj/ehac709
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Biomedical Systems Informatics (의생명시스템정보학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
You, Seng Chan(유승찬) ORCID logo https://orcid.org/0000-0002-5052-6399
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Lee, Yong Joon(이용준)
Lee, Yong Ho(이용호) ORCID logo https://orcid.org/0000-0002-6219-4942
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/194074
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