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This prespecified subgroup analysis compared the effect of combined ezetimibe and moderate-intensity statin therapy with that of high-intensity statin monotherapy in a cohort of 1398 patients with diabetes mellitus and atherosclerotic cardiovascular disease from the RACING trial. At 3 years, the incidence of cardiovascular death, major adverse cardiovascular events, and nonfatal stroke was not significantly different between the groups; however, the rate of intolerance-related drug discontinuation or dose reduction was lower and the proportion of patients achieving LDL-C levels <70 mg/dL was higher in the ezetimibe combination therapy group than in the high-intensity statin monotherapy group.
Among patients with diabetes and atherosclerosis, ezetimibe plus moderate-intensity statin therapy is a safe and effective alternative to high-intensity statin monotherapy for the secondary prevention and management of dyslipidemia.
This abstract is available on the publisher's site.
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.
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.
Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial
Eur Heart J 2022 Dec 19;[EPub Ahead of Print], YJ Lee, JY Cho, SC You, YH Lee, KH Yun, YH Cho, WY Shin, SW Im, WC Kang, Y Park, SY Lee, SJ Lee, SJ Hong, CM Ahn, BK Kim, YG Ko, D Choi, MK Hong, Y Jang, JS Kim