Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia
Article first published online: 30 MAR 2007
Volume 95, Issue 11, pages 1461–1466, November 2006
How to Cite
Van Der Graaf, A., Nierman, M. C., Firth, J. C., Wolmarans, K. H., Marais, A. D. and De Groot, E. (2006), Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia. Acta Paediatrica, 95: 1461–1466. doi: 10.1080/08035250600702602
- Issue published online: 30 MAR 2007
- Article first published online: 30 MAR 2007
- Received 29 November 2005; revised 27 January 2006; accepted 20 March 2006
- familial hypercholesterolaemia;
Aim: To assess whether early initiation of statin therapy for heterozygous familial hypercholesterolaemia favourably affects lipid profiles or vascular morphological changes. 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 (β) were recorded. Eighty of the 85 enrolled subjects completed the trial. 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 (ΔIMT −0.005 mm, 95% CI −0.018 to +0.007 mm, n=83; and Δβ= 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.
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.