Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

Summary

This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.

Timeline

Start

2023-07-26

Primary completion

2024-09-04

Completion

2024-10-15

Outcome

Met primary endpoint

registry analysis (other test); Ezetimibe/Atorvastatin vs Atorvastatin; p <0.0001; Least Squares (LS) mean difference -21.22 (95% CI -29.26 to -13.19); ANCOVA; NCT05761444 ↗

paper The EZ/AS lipid-lowering effect was statistically greater than AS monotherapy at week 6 (LSMD: -21.2; P < 0.0001) and week 12 (LSMD: -16.0; P < 0.0001). PMID 41673582 ↗

Publications

• Kang SH, Kwon SU, Lee JY, Seo SM, Nam CW, Park GM, Hong YJ, Lee WY, Jang JE, Chae IH. The role of early ezetimibe combination with atorvastatin in patients with atherosclerotic cardiovascular disease. BMC Cardiovasc Disord. 2026 Feb 11;26(1):233. doi: 10.1186/s12872-026-05594-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atorvastatin	Small molecule	40 mg	Oral
Comparator	Atorvastatin	Small molecule	80 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral

Indications