1. Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial.
- Author
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Lee YJ, Cho JY, You SC, Lee YH, Yun KH, Cho YH, Shin WY, Im SW, Kang WC, Park Y, Lee SY, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, and Kim JS
- Subjects
- Humans, Ezetimibe therapeutic use, Cholesterol, LDL, Treatment Outcome, Drug Therapy, Combination, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Anticholesteremic Agents adverse effects, Cardiovascular Diseases drug therapy, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology, Atherosclerosis drug therapy, Atherosclerosis prevention & control
- Abstract
Aims: This study evaluated the effect of moderate-intensity statin with ezetimibe combination therapy vs. high-intensity statin monotherapy among patients with diabetes mellitus (DM) and atherosclerotic cardiovascular disease (ASCVD)., Methods and Results: This was a pre-specified, stratified subgroup analysis of the DM cohort in the RACING trial. The primary outcome was a 3-year composite of cardiovascular death, major cardiovascular events, or non-fatal stroke. Among total patients, 1398 (37.0%) had DM at baseline. The incidence of the primary outcome was 10.0% and 11.3% among patients with DM randomized to ezetimibe combination therapy vs. high-intensity statin monotherapy (hazard ratio: 0.89; 95% confidence interval: 0.64-1.22; P = 0.460). Intolerance-related discontinuation or dose reduction of the study drug was observed in 5.2% and 8.7% of patients in each group, respectively (P = 0.014). LDL cholesterol levels <70 mg/dL at 1, 2, and 3 years were observed in 81.0%, 83.1%, and 79.9% of patients in the ezetimibe combination therapy group, and 64.1%, 70.2%, and 66.8% of patients in the high-intensity statin monotherapy group (all P < 0.001). In the total population, no significant interactions were found between DM status and therapy regarding primary outcome, intolerance-related discontinuation or dose reduction, and the proportion of patients with LDL cholesterol levels <70 mg/dL., Conclusion: Ezetimibe combination therapy effects observed in the RACING trial population are preserved among patients with DM. This study supports moderate-intensity statin with ezetimibe combination therapy as a suitable alternative to high-intensity statins if the latter cannot be tolerated, or further reduction in LDL cholesterol is required among patients with DM and ASCVD., Clinical Trial Registration: ClinicalTrials.gov, Identifier:NCT03044665., Competing Interests: Conflict of interest: S.C.Y. is a chief technical officer of PHI Digital Healthcare and has received consulting fee from IQVIA; B.-K.K. has received speaker’s fees from Medtronic and Abbott Vascular; M.-K.H. has received speaker’s fees from Medtronic, Abbott Vascular, and Pfizer, Y.J. has received institutional research grants from Biotronik and Hanmi, and J.-S.K. has received proctoring fees from Abbott Vascular. All other authors declare no competing interests., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
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