6/29/23, 12:42 AM RACING Pathway Feedback Search Clinical Topics Home Studies RACING RACING Disease Disease Disease Coronary artery disease Diabetes mellitus type 2 Dyslipidem Trial question What is the role of ezetimibe combination therapy in patients with diabetes mellitus and ASCVD? Study design Multi-center Open label RCT Population 1398 patients Inclusion criteria: adult patients with diabetes mellitus and ASCVD Key exclusion criteria: active liver disease; solid organ transplantation recipient; allergy / hypersensitivity to any statin or ezetimibe; life expectancy < 3 years Interventions N=701 moderate-intensity statin plus ezetimibe combination therapy (rosuvastatin 10 mg plus ezetimibe 10 mg per day) N=697 high-intensity statin monotherapy (rosuvastatin 20 mg/day) Primary outcome Composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years 11.3 % 11.3 10 8.5 % 5.7 % 2.8 % No significant difference 0.0 % https://web.pathway.md/studies/recAnspeFn8iknCC3 1/2 6/29/23, 12:42 AM RACING Pathway Moderate-intensity statin plus ezetimibe combination therapy High-intensity statin monotherapy No significant difference in composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years (10% vs. 11.3%; HR 0.89, 95% CI -1.43 to 3.21) Secondary outcomes Significant decrease in intolerance-related discontinuation or dose reduction of the study drug (5.2% vs. 8.7%; ARD -3.5, 95% CI -6.29 to -0.71) Significant increase in low-density lipoprotein cholesterol levels < 70 mg/dL at 1 year (81% vs. 64.1%; AD 16.9%, 95% CI 6.87 to 26.93) Significant increase in low-density lipoprotein cholesterol levels < 70 mg/dL at 3 years (79.9% vs. 66.8%; AD 13.1%, 95% CI 5.33 to 20.87) Conclusion In adult patients with diabetes mellitus and ASCVD, moderate-intensity statin plus ezetimibe combination therapy was not superior to high-intensity statin monotherapy with respect to the composite of cardiovascular death, major cardiovascular events, or nonfatal stroke at 3 years. Reference Yong-Joon Lee, Jae Young Cho, Seng Chan You et al. Moderate-intensity statin with ezetimibe vs. high-intensity statin in patients with diabetes and atherosclerotic cardiovascular disease in the RACING trial. Eur Heart J. 2023 Mar 14;44(11):972-983. Open reference URL https://web.pathway.md/studies/recAnspeFn8iknCC3 2/2