Abstract: Competing Interests: Declarations. Ethics approval and consent to participate: The research ethics committee of the Faculty of Medicine, Alexandria University, Egypt, reviewed and approved the study protocol. The study methodology was developed in accordance with the Declaration of Helsinki. Consent for publication: Not applicable. Informed consent : All patients signed an informed written consent for study participation. Competing interests: Prof Hala Mahfouz Badran is a co-author of this study and an Editor-in-Chief for the journal and Prof Mohamed Sobhy is a coauthor of this study and an Editorial Board member for the journal. They were not involved in handling this manuscript. The rest of the authors have no conflict of interest to declare.
Background: Lipid-lowering therapies (LLT) are well-established in reducing cardiovascular complications and improving outcomes in patients with atherosclerotic cardiovascular disease (ASCVD). However, the efficacy of LLT varies across different ethnic and geographical populations, necessitating further investigation.
Objectives: To evaluate the real-world efficacy and safety of the combination therapy of Ezetimibe 10 mg/Rosuvastatin 40 mg in Egyptian patients at very high risk of ASCVD.
Methods: This multicenter, prospective, single-arm, open-label study enrolled adult patients with documented ASCVD or at very high-risk profiles. Lipid parameters, including total cholesterol (TC), LDL-C, HDL-C, non-HDL-C, and triglycerides, were measured at baseline, 6 weeks, and 12 weeks. The primary endpoint was the proportion of patients achieving the ESC LDL-C target (< 55 mg/dL and ≥ 50% reduction). Safety assessments included adverse events, skeletal myopathy, hepatic enzyme alterations, and treatment discontinuation.
Results: A total of 1,854 participants from 25 centers across Egypt completed the 12-week follow-up. The mean age was 56 ± 11 years, with 68% male participants. Hypertension was prevalent in 72.7%, diabetes in 47.6%, smoking in 38.7%, prior ACS in 38.9%, previous percutaneous coronary intervention (PCI) in 43.7%, and prior CABG in 10.4% of the cohort. By week 12, TC decreased by 42.9%, LDL-C by 58.7%, and non-HDL-C by 54%, while HDL-C increased by 9.4%. LDL-C levels < 55 mg/dL were achieved in 35.5% of participants, ≥ 50% LDL-C reduction in 70.3%, and 32.2% met the combined ESC LDL-C goal. Skeletal muscle symptoms occurred in 11.4%, elevated liver enzymes in 4.9%, mostly mild in severity. Treatment discontinuation was minimal (1.9%), with most patients maintaining therapy.
Conclusion: In Egyptian patients at very high risk of ASCVD, the combination of Ezetimibe 10 mg/Rosuvastatin 40 mg over 12 weeks demonstrated substantial LDL-C reduction and high attainment of ESC targets, with an acceptable safety profile.
(© 2025. The Author(s).)
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