Efficacy and safety of ezetimibe in young children with familial hypercholesterolemia

INTERVENTION: Ezetimibe 10 mg/day versus placebo treatment for 4 months CONDITION: Familial hypercholesterolemia (FH) ; Nutritional, Metabolic, Endocrine ; Familial hypercholesterolemia PRIMARY OUTCOME: Primary endpoint will be the efficacy towards LDL‐C levels and the safety of 10 mg ezetimibe. SECONDARY OUTCOME: Secondary endpoint will be the effect of 10 mg ezetimibe on inflammatory markers and plant sterols in plasma. INCLUSION CRITERIA: 1. Male or female 2. Aged 8‐14 years 3. Heterozygous familial hypercholesterolemia defined as: a. Molecular diagnosis of FH AND LDL‐C above 95th percentile for age and sex (LDL‐C >3.88 mmol/l) despite a lipid‐lowering diet for at least 3 months b. LDL‐cholesterol above 95th percentile for age and sex (LDL‐C >3.88 mmol/l) despite a lipid‐lowering diet for at least 3 months c. One parent with either a clinical or molecular diagnosis of FH