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Efficacy and safety of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia
Author(s) -
Van Der Graaf Anouk,
Nierman Melchior C.,
Firth Jean C.,
Wolmarans Karen H.,
Marais A. David,
Groot Eric
Publication year - 2006
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1080/08035250600702602
Subject(s) - medicine , fluvastatin , apolipoprotein b , cholesterol , endocrinology , statin , familial hypercholesterolemia , arterial stiffness , intima media thickness , gastroenterology , cardiology , carotid arteries , simvastatin , blood pressure
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.