LDL-C Goal Attainment with Fixed-Dose Ezetimibe and Atorvastatin Versus High-Dose Atorvastatin in Chinese Patients: Subgroup Analysis of a Randomized Trial

INTRODUCTION: Combining ezetimibe (EZ) and statins is recommended for the treatment of elevated low-density lipoprotein-cholesterol (LDL-C). This subgroup analysis evaluated the efficacy of fixed-dose combination (FDC) therapy with EZ and atorvastatin (AS) versus AS monotherapy on attaining LDL-C goals in Chinese patients with very high risk of atherosclerotic cardiovascular disease (ASCVD) grouped by ASCVD risk, age, and sex. METHODS: Data from the phase III, randomized, double-blind study (NCT03768427) compared EZ10/AS10 mg FDC versus AS20 mg (cohort A), and EZ10/AS20 mg FDC versus AS40 mg monotherapy (cohort B) in Chinese patients with uncontrolled hypercholesterolemia. Proportions of patients attaining 2016 Chinese guideline-recommended LDL-C goals (low/medium risk [< 130 mg/dL], high risk [< 100 mg/dL], very high risk [< 70 mg/dL]) were assessed at weeks 6 and 12. Subgroup analyses by ASCVD risk, age (< 65 and ≥ 65 years), and sex were conducted. RESULTS: LDL-C goal attainment was significantly higher with FDCs versus AS monotherapy at week 12 (cohort A: 62.7% vs. 35.1%, P = 0.0009; cohort B: 67.5% vs. 31.0%, P < 0.0001). A greater proportion of patients with very high ASCVD risk attained LDL-C goals with FDCs versus AS monotherapy at week 12 (cohort A: 62.3% vs. 33.9%; cohort B: 69.1% vs. 29.5%). LDL-C goal attainment was higher with FDCs versus individual doses of AS at weeks 6 and 12 in both cohorts, regardless of age or sex. CONCLUSION: FDCs significantly improved LDL-C goal attainment compared to AS monotherapy in patients with very high ASCVD risk. In the subgroups by age and sex, a higher proportion of patients with uncontrolled hypercholesterolemia attained their LDL-C goals. TRIAL REGISTRY: Trial registration number NCT03768427.