EClinicalMedicine (Oct 2023)

Treat-to-target versus high-intensity statin treatment in patients with or without diabetes mellitus: a pre-specified analysis from the LODESTAR trialResearch in context

  • Seung-Jun Lee,
  • Woong Chol Kang,
  • Jong-Young Lee,
  • Jin-Bae Lee,
  • Tae-Hyun Yang,
  • Junghan Yoon,
  • Yong-Joon Lee,
  • Sung-Jin Hong,
  • Chul-Min Ahn,
  • Jung-Sun Kim,
  • Byeong-Keuk Kim,
  • Young-Guk Ko,
  • Donghoon Choi,
  • Bum-Kee Hong,
  • Yangsoo Jang,
  • Myeong-Ki Hong,
  • Myeong-Ki Hong,
  • Donghoon Choi,
  • Young-Guk Ko,
  • Byeong-Keuk Kim,
  • Jung-Sun Kim,
  • Chul-Min Ahn,
  • Sung-Jin Hong,
  • Seung-Jun Lee,
  • Yong-Joon Lee,
  • Bum-Kee Hong,
  • Hyuck Moon Kwon,
  • Jong-Youn Kim,
  • Pil Ki Min,
  • Young Won Yoon,
  • Byoung Kwon Lee,
  • Se-Joong Rim,
  • Eui-Young Choi,
  • Woong CholKang,
  • Pyung Chun Oh,
  • Jong-Young Lee,
  • Jin-Bae Lee,
  • Kee Sik Kim,
  • Ji Yong Choi,
  • Jae Kean Ryu,
  • Seung Pyo Hong,
  • Chang Yeon Kim,
  • Tae-Hyun Yang,
  • Hyung-Jin Cho,
  • Junghan Yoon,
  • Min-Soo Ahn,
  • Sung Gyun Ahn,
  • Jun-Won Lee,
  • Jung-Woo Son,
  • Yangsoo Jang,
  • Hyuck-Jun Yoon,
  • Cheol Hyun Lee,
  • Jongmin Hwang,
  • Yun-Kyeong Cho,
  • Seung-Ho Hur,
  • Seongwook Han,
  • Chang-Wook Nam,
  • Hyoungseop Kim,
  • Hyoung-Seob Park,
  • In-Cheol Kim,
  • Yun-Hyeong Cho,
  • Hyeon-Ju Jeong,
  • Jin-Ho Kim,
  • Chewan Lim,
  • Yongsung Suh,
  • Eui Seok Hwang,
  • Ji Hyun Lee,
  • Sung Yun Lee,
  • Sung Uk Kwon,
  • Song-Yi Kim,
  • Keun-Ho Park,
  • Hyun Kuk Ki

Journal volume & issue
Vol. 64
p. 102227

Abstract

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Summary: 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. Funding: Sam Jin Pharmaceutical, Seoul, Korea and Chong Kun Dang Pharmaceutical, Seoul, Korea.

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