Efficacy and safety of combination therapy Ezetimibe 10/rosuvastatin 40 in Egyptian patients at very high risk of atherosclerotic cardiovascular disease.

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.