title: Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk.
abstract: OBJECTIVE
  To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia.
  
  
  METHODS
  A 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.
  
  
  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 were evident.
  
  
  CONCLUSIONS
  Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years.
  
  
  BACKGROUND
  Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.
authors.affiliation: Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands; Department of Pediatrics, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: j.a.braamskamp@amc.uva.nl.
authors.forename: Marjet J A M
authors.initials: MJ
authors.lastname: Braamskamp
authors.affiliation: Extracorporeal Therapeutic Techniques Unit, Lipid Clinic and Atherosclerosis Prevention Center, Department of Molecular Medicine, 'Sapienza' University of Rome, 'Umberto I' Hospital, Rome, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Stefanutti
authors.affiliation: Lipid Clinic, Oslo University Hospital, Oslo, Norway.
authors.forename: Gisle
authors.initials: G
authors.lastname: Langslet
authors.affiliation: Unit on Metabolic Diseases, Choremio Research Laboratory, University of Athens, 1st Department of Pediatrics, Aghia Sophia Children's Hospital, Athens, Greece.
authors.forename: Euridiki
authors.initials: E
authors.lastname: Drogari
authors.affiliation: Department of Pediatrics, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Albert
authors.initials: A
authors.lastname: Wiegman
authors.affiliation: Kowa Research Europe Ltd, Wokingham, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Hounslow
authors.affiliation: Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: John J P
authors.initials: JJ
authors.lastname: Kastelein
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001053:Apolipoproteins / Q000097:blood; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology*; D002648:Child; D002784:Cholesterol / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000097:blood / Q000188:drug therapy*; D008297:Male; D011804:Quinolines / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D001053:Apolipoproteins; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D014280:Triglycerides; D002784:Cholesterol; C108475:pitavastatin