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

AbstractOBJECTIVES:
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 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.
TRIAL REGISTRATION:
Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.
AuthorsMarjet J A M Braamskamp, Claudia Stefanutti, Gisle Langslet, Euridiki Drogari, Albert Wiegman, Neil Hounslow, John J P Kastelein, PASCAL Study Group
JournalThe Journal of pediatrics (J Pediatr) Vol. 167 Issue 2 Pg. 338-43.e5 (Aug 2015) ISSN: 1097-6833 [Electronic] United States
PMID26059337 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2015 Elsevier Inc. All rights reserved.
Chemical References
  • Apolipoproteins
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Quinolines
  • Triglycerides
  • Cholesterol
  • pitavastatin
Topics
  • Adolescent
  • Age Factors
  • Apolipoproteins (blood)
  • Cardiovascular Diseases (blood, etiology)
  • Child
  • Cholesterol (blood)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Europe
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors (pharmacokinetics, therapeutic use)
  • Hyperlipidemias (blood, drug therapy)
  • Male
  • Quinolines (pharmacokinetics, therapeutic use)
  • Risk Factors
  • Treatment Outcome
  • Triglycerides (blood)

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