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Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial

Authors
 Yong-Joon Lee  ;  Sung-Jin Hong  ;  Woong Chol Kang  ;  Bum-Kee Hong  ;  Jong-Young Lee  ;  Jin-Bae Lee  ;  Hyung-Jin Cho  ;  Junghan Yoon  ;  Seung-Jun Lee  ;  Chul-Min Ahn  ;  Jung-Sun Kim  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Yangsoo Jang  ;  Myeong-Ki Hong  ;  LODESTAR investigators 
Citation
 BMJ-BRITISH MEDICAL JOURNAL, Vol.383 : e075837, 2023-10 
Journal Title
BMJ-BRITISH MEDICAL JOURNAL
ISSN
 0959-8138 
Issue Date
2023-10
MeSH
Adult ; Atorvastatin* / adverse effects ; Cataract ; Cholesterol, LDL ; Coronary Artery Disease* / drug therapy ; Diabetes Mellitus ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects ; Myocardial Infarction ; Rosuvastatin Calcium* / adverse effects ; Stroke ; Treatment Outcome ; Young Adult
Abstract
Objective: To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease.

Design: Randomised, open label, multicentre trial.

Setting: 12 hospitals in South Korea, September 2016 to November 2019.

Participants: 4400 adults (age ≥19 years) with coronary artery disease.

Interventions: Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation.

Main outcome measures: The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities.

Results: 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups.

Conclusions: In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin.
Files in This Item:
T202306304.pdf Download
DOI
10.1136/bmj-2023-075837
Appears in Collections:
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
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Lee, Yong Joon(이용준)
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, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/196779
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