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Randomized Controlled Trial
. 2023 Mar 14;44(11):972-983.
doi: 10.1093/eurheartj/ehac709.

Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial

Yong-Joon Lee  1 , Jae Young Cho  2 , Seng Chan You  3 , Yong-Ho Lee  1 , Kyeong Ho Yun  2 , Yun-Hyeong Cho  4 , Won-Yong Shin  5 , Sang Wook Im  6 , Woong Chol Kang  7 , Yongwhi Park  8 , Sung Yoon Lee  9 , Seung-Jun Lee  1 , Sung-Jin Hong  1 , Chul-Min Ahn  1 , Byeong-Keuk Kim  1 , Young-Guk Ko  1 , Donghoon Choi  1 , Myeong-Ki Hong  1 , Yangsoo Jang  6 , Jung-Sun Kim  1
Affiliations
Randomized Controlled Trial

Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial

Yong-Joon Lee et al. Eur Heart J. .

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.

Keywords: Atherosclerotic cardiovascular disease; Diabetes mellitus; Ezetimibe; Statin.

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Conflict of interest statement

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.

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