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

Abstract: Objectives: Elevated low-density lipoprotein cholesterol (LDL-C) is a risk factor for coronary heart disease (CHD) in adults, but the underlying atherogenesis begins in childhood. Therefore guidelines recommend consideration of statin therapy in children at high future CVD risk. The aim of the study was to assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia. Study design: A total of 106 hyperlipidemic children and adolescents, 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 LDL-C treatment target of 110mg/dL (2.8 mmol/L). Safety was assessed in terms of adverse event rates, including abnormal clinical laboratory variables, vital signs and physical examination.Results: Compared 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 became evident.Conclusion: Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years.