Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk

ObjectivesTo assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia.Study designA total of 106 children and adolescents with hyperlipidemia, ages 6 to 17 years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1 mg, 2 mg, 4 mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1 mg pitavastatin to a maximum dose of 4 mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110 mg/dL (2.8 mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed.ResultsCompared with placebo, pitavastatin 1, 2, and 4 mg significantly reduced LDL-C from baseline by 23.5%, 30.1%, and 39.3%, respectively, and in the open-label study 20.5% of the subjects reached the LDL-C goal <110 mg/dL (2.8 mmol/L). No safety issues were evident.ConclusionsPitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years.Trial registrationRegistered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.