Frontiers in cardiovascular medicine · 2026
Effect of rosuvastatin and ezetimibe therapy on LDL-cholesterol reduction and non-invasive arterial injury markers in children with heterozygous familial hypercholesterolemia: a prospective, open-label, randomized study.
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Skarlovnik Ajda, Gorjanc Tevz, Sikonja Jaka, Kafol Jan, Mlinaric Matej, Cugalj Kern Barbara, Drole Torkar Ana, Kovac Jernej, Rodaro Chiara, Battelino Tadej, Groselj Urh
Аннотация
BACKGROUND AND AIMS: Individuals with familial hypercholesterolemia (FH) require early lipid-lowering therapy (LLT). We compared rosuvastatin versus ezetimibe treatment and the role of major non-invasive arterial injury markers in children with heterozygous FH.
METHODS: In this prospective, open-label, randomized study, 45 children with FH [median age 10.5 years (IQR 8.7-14.5)] received rosuvastatin 5 mg OD or ezetimibe 10 mg OD for 6.2 months. Carotid intima-media thickness (cIMT), reactive hyperemia index (RHI), pulse wave velocity (PWV), and beta stiffness were evaluated in relation to anthropometric and lipid-related variables.
RESULTS: Rosuvastatin produced a greater LDL-C reduction than ezetimibe (36.7% vs. 18.3%; p < 0.001) with 9/20 (45%) children achieving LDL-C <3.5 mmol/L compared to 2/15 (13%) in ezetimibe group. No reports of myalgias, elevations in transaminases, or creatine kinase (CK) were observed in any of the groups. Markers at baseline correlated mainly with age and anthropometry. Beta stiffness decreased during LLT in the overall cohort (-0.24; 95% CI -0.51 to -0.03, p = 0.002) and in the rosuvastatin group (-0.4; 95% CI -0.7 to -0.1, p = 0.028), with no between-group difference (p = 0.266). This likely reflects regression to the mean, as LDL-C reduction and treatment allocation had only small effects across all markers.
CONCLUSIONS: Rosuvastatin achieved greater LDL-C reduction than ezetimibe in children with FH, without difference in safety and tolerability profiles. Arterial injury markers correlated mainly with age and anthropometry, and their short-term changes were not treatment-related, likely due to limited power and the short follow-up.
METHODS: In this prospective, open-label, randomized study, 45 children with FH [median age 10.5 years (IQR 8.7-14.5)] received rosuvastatin 5 mg OD or ezetimibe 10 mg OD for 6.2 months. Carotid intima-media thickness (cIMT), reactive hyperemia index (RHI), pulse wave velocity (PWV), and beta stiffness were evaluated in relation to anthropometric and lipid-related variables.
RESULTS: Rosuvastatin produced a greater LDL-C reduction than ezetimibe (36.7% vs. 18.3%; p < 0.001) with 9/20 (45%) children achieving LDL-C <3.5 mmol/L compared to 2/15 (13%) in ezetimibe group. No reports of myalgias, elevations in transaminases, or creatine kinase (CK) were observed in any of the groups. Markers at baseline correlated mainly with age and anthropometry. Beta stiffness decreased during LLT in the overall cohort (-0.24; 95% CI -0.51 to -0.03, p = 0.002) and in the rosuvastatin group (-0.4; 95% CI -0.7 to -0.1, p = 0.028), with no between-group difference (p = 0.266). This likely reflects regression to the mean, as LDL-C reduction and treatment allocation had only small effects across all markers.
CONCLUSIONS: Rosuvastatin achieved greater LDL-C reduction than ezetimibe in children with FH, without difference in safety and tolerability profiles. Arterial injury markers correlated mainly with age and anthropometry, and their short-term changes were not treatment-related, likely due to limited power and the short follow-up.