1. 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
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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, 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, Kee Sik Kim, Ji Yong Choi, Jae Kean Ryu, Seung Pyo Hong, Chang Yeon Kim, Hyung-Jin Cho, Min-Soo Ahn, Sung Gyun Ahn, Jun-Won Lee, Jung-Woo Son, 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, and Hyun Kuk Ki
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Coronary artery disease ,Atherosclerosis ,Cholesterol ,Statin ,Diabetes ,Medicine (General) ,R5-920 - Abstract
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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- 2023
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