Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial
- 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.
- All Author(s)
- Y. J. Lee
; J. Y. Cho
; S. C. You
; Y. H. Lee
; K. H. Yun
; Y. H. Cho
; W. Y. Shin
; S. W. Im
; W. C. Kang
; Y. Park
; S. Y. Lee
; S. J. Lee
; S. J. Hong
; C. M. Ahn
; B. K. Kim
; Y. G. Ko
; D. Choi
; M. K. Hong
; Y. Jang
; J. S. Kim
- Issued Date
- 2022
- Type
- Article
- Keyword
- Ezetimibe; Statin; Diabetes mellitus; Atherosclerotic cardiovascular disease
- Publisher
- European Society of Cardiology
- ISSN
- 0195-668x
- Citation Title
- European Heart Journal
- Citation Volume
- 44
- Citation Number
- 11
- Citation Start Page
- 972
- Citation End Page
- 983
- Language(ISO)
- eng
- DOI
- 10.1093/eurheartj/ehac709
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/2625
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