title: Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia.
abstract: OBJECTIVE
  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 (beta) 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 (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Vascular Medicine, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Anouk
authors.initials: A
authors.lastname: van der Graaf
authors.forename: Melchior C
authors.initials: MC
authors.lastname: Nierman
authors.forename: Jean C
authors.initials: JC
authors.lastname: Firth
authors.forename: Karen H
authors.initials: KH
authors.lastname: Wolmarans
authors.forename: A David
authors.initials: AD
authors.lastname: Marais
authors.forename: Eric
authors.initials: E
authors.lastname: de Groot
mesh_terms: D000293:Adolescent; D050197:Atherosclerosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D002339:Carotid Arteries / Q000000981:diagnostic imaging*; D002648:Child; D003692:Delayed-Action Preparations; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy*; D007211:Indoles / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D016037:Single-Blind Method; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D003692:Delayed-Action Preparations; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D008055:Lipids; D000077340:Fluvastatin