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Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia.
- 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.
- Subjects :
- Adolescent
Atherosclerosis diagnostic imaging
Child
Delayed-Action Preparations
Female
Fluvastatin
Humans
Hyperlipoproteinemia Type II blood
Lipids blood
Male
Single-Blind Method
Treatment Outcome
Ultrasonography
Atherosclerosis prevention & control
Carotid Arteries diagnostic imaging
Fatty Acids, Monounsaturated therapeutic use
Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
Hyperlipoproteinemia Type II drug therapy
Indoles therapeutic use
Subjects
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