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Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia.

Authors :
van der Graaf A
Nierman MC
Firth JC
Wolmarans KH
Marais AD
de Groot E
Source :
Acta paediatrica (Oslo, Norway : 1992) [Acta Paediatr] 2006 Nov; Vol. 95 (11), pp. 1461-6.
Publication Year :
2006

Abstract

Aim: To assess whether early initiation of statin therapy for heterozygous familial hypercholesterolaemia favourably affects lipid profiles or vascular morphological changes.<br />Methods: Children and adolescents aged 10-16 y with heterozygous familial hypercholesterolaemia were administered fluvastatin (80 mg/d) for 2 y in a single-arm two-centre study. Carotid B-mode intima-media thickness (IMT) and M-mode arterial wall stiffness (beta) were recorded. Eighty of the 85 enrolled subjects completed the trial.<br />Results: The median decrease in low-density lipoprotein (LDL) cholesterol from baseline at last study visit was 33.9%; median decreases in total cholesterol, triglycerides and apolipoprotein B were 27.1%, 5.3% and 24.2%, respectively; the median increase in high-density lipoprotein (HDL) cholesterol was 5.3%. Changes in carotid arterial wall thickness and stiffness versus baseline were fractional and statistically non-significant (delta IMT -0.005 mm, 95% CI -0.018 to +0.007 mm, n=83; and delta beta = 0.017, 95% CI -0.219 to +0.253, n=79). Adverse events, all non-serious, were reported by 58 subjects (68.2%); four were suspected to be drug-related. Change in hormone levels and sexual maturation were appropriate for this age group.<br />Conclusion: Fluvastatin lowered LDL cholesterol, total cholesterol and apolipoprotein B levels effectively over a prolonged period in children and adolescents with heterozygous familial hypercholesterolaemia. Carotid IMT and wall stiffness remained largely unchanged.

Details

Language :
English
ISSN :
0803-5253
Volume :
95
Issue :
11
Database :
MEDLINE
Journal :
Acta paediatrica (Oslo, Norway : 1992)
Publication Type :
Academic Journal
Accession number :
17062478
Full Text :
https://doi.org/10.1080/08035250600702602