RACING
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 CV death, major CV events, or nonfatal stroke at 3 years
10%
11.3%
11.3 %
8.5 %
5.7 %
2.8 %
0.0 %
Moderate-intensity statin plus ezetimibe combination
therapy
High-intensity statin
monotherapy
No significant
difference ↔
No significant difference in CV death, major CV 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 LDL-C levels < 70 mg/dL at 1 year (81% vs. 64.1%; AD 16.9%, 95% CI 6.87 to 26.93).
Significant increase in LDL-C 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 CV death, major CV 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.
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