Avis 2010

Methods	* Design: RCT * Randomization stratified by center * Blinding: double * Concealment of allocation: nr * Setting: 20 centers * Country: Netherlands, Canada, Norway, USA * Follow‐up: 12 weeks
Participants	Individuals with HeFH (N = 177) * Diagnosis: documented genetic effect or LDL‐C ≧ 190 mg/dL or LDL‐C > 160 mg/dL and early CVD in family * Inclusion: age 10 ‐ 17 years, HeFH, Tanner stage ≧ II, females at least 1 year post‐menarche * Exclusion: nr * Base population: nr Age: 10 ‐ 17 years Male: 55% Race: White populations 94% Height (mean): 164 cm Weight (mean): 58 kg BMI (mean): nr LDL‐C (mean):? mmol/L (233 mg/dL)
Interventions	* Treatment: rosuvastatin in 3 treatment arms (n = 130), 5 mg daily (n = 42), 10 mg daily (n = 44) and 20 mg daily (n = 45) * Control: placebo (n = 46) * Run‐in: diet only for 6 weeks * Diet: nr
Outcomes	LDL‐C: Friedewald's formula TC HDLC TG ASAT ALAT CK Myopathy: myalgia Adverse events: adverse event
Notes	* Open‐label phase for 40 weeks after the RCT, data not used in this review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as stratified but randomization procedure not described.
Allocation concealment (selection bias)	Unclear risk	nr
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Compliance: 87% Dropout: 2% Losses to follow‐up: 1% Missing from analysis: 1%
Selective reporting (reporting bias)	Unclear risk	No indication to suspect selective reporting.