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EClinicalMedicine, Oct 2023, 64 102227 | https://doi.org/10.1016/j.eclinm.2023.102227 Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trial.

Seung-Jun Lee ^a,i, Woong Chol Kang ^b,i, Jong-Young Lee^c,i, Jin-Bae Lee ^d, Tae-Hyun Yang ^e, Junghan Yoon ^f, Yong-Joon Lee ^a, Sung-Jin Hong ^a, Chul-Min Ahn ^a, Jung-Sun Kim ^a, Byeong-Keuk Kim ^a, Young-Guk Ko ^a, Donghoon Choi ^a, Bum-Kee Hong ^g, Yangsoo Jang^h, Myeong-Ki Hong^a; LODESTAR Investigators

^aSeverance Hospital, Yonsei University College of Medicine, Seoul, Korea

^bGachon University Gil Medical Center, Incheon, Korea

^cKangbuk Samsung Hospital, Sungkyunkwan University Scholl of Medicine, Seoul, Korea

^dDaegu Catholic University Medical Center, Daegu, Korea

^eInje University Busan Paik Hospital, Busan, Korea

^fWonju Severance Christian Hospital, Wonju, Korea

^gGangnam Severance Hospital, Seoul, Korea

^hCHA University College of Medicine, Seongnam, Korea

ⁱThese authors contributed equally to this work.

Corresponding authors: Bum-Kee Hong, Myeong-Ki Hong

Abstract

Background: The impact of titrated versus fixed intensity statin therapy in patients with coronary artery disease (CAD) and diabetes mellitus (DM) remains to be elucidated.

Methods: This was a pre-specified analysis of patients with and without DM from the LODESTAR trial. Patients with CAD were randomly assigned to receive either a treat-to-target strategy with a target LDL-C level of 50-70 mg/dL or a high-intensity statin treatment. Primary outcome was the 3-year composite of all-cause death, myocardial infarction, stroke, or coronary revascularization. Secondary outcomes were safety endpoints. This trial is registered with ClinicalTrials.gov, NCT02579499.

Findings: Between September 9, 2016 and November 27, 2019, 4400 patients with CAD were enrolled in the LODESTAR trial. The median age was 65 years (interquartile range, 59-73 years), 3172 (72%) were male, and 1468 (33%) had DM at baseline. There was no significant difference in the occurrence of the primary outcome between the treat-to-target group and high-intensity statin group among patients with DM (10.5% versus 11.1%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69-1.29, p = 0.70) and those without DM (6.9% versus 7.5%, HR 0.93, 95% CI 0.71-1.21, p = 0.58). Among patients without DM, there was a trend towards a lower risk of new-onset DM in the treat-to-target group (8.4% versus 10.4% in the high-intensity statin group, HR 0.79, 95% CI 0.62-1.01; p = 0.06).

Interpretation: In patients with CAD, a treat-to-target LDL-C strategy of 50-70 mg/dL as the goal was comparable to high-intensity statin therapy in terms of 3-year clinical efficacy and safety outcomes regardless of the presence of DM.

논문정보

형식Research article
게재일2023년 10월 (BRIC 등록일 2023-10-05)
연구진국내 연구진
분야 의약학 > 응용의학

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