Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk
Marjet J.A.M. Braamskamp, Claudia Stefanutti, Gisle Langslet, Euridiki Drogari
DOI:
http://dx.doi.org/10.1016/j.jpeds.2015.05.006 Abstract
Objectives
To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia.
Study design
A total of 106 children and adolescents with hyperlipidemia, ages 6 to 17years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1mg, 2mg, 4mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1mg pitavastatin to a maximum dose of 4mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110mg/dL (2.8mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed.
Results
Compared with placebo, pitavastatin 1, 2, and 4mg 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 <110mg/dL (2.8mmol/L). No safety issues were evident.
Conclusions
Pitavastatin at doses up to 4mg is well tolerated and efficacious in children and adolescents aged 6-17years.
