Abstract | OBJECTIVES: 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.
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Authors | Marjet J A M Braamskamp, Claudia Stefanutti, Gisle Langslet, Euridiki Drogari, Albert Wiegman, Neil Hounslow, John J P Kastelein, PASCAL Study Group |
Journal | The Journal of pediatrics
(J Pediatr)
Vol. 167
Issue 2
Pg. 338-43.e5
(Aug 2015)
ISSN: 1097-6833 [Electronic] United States |
PMID | 26059337
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
Chemical References |
- Apolipoproteins
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Quinolines
- Triglycerides
- Cholesterol
- pitavastatin
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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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