Efficacy and Safety of Pitavastatin in Children and Adolescents at High Future Cardiovascular Risk
| Autor: | Braamskamp, Mj, Stefanutti, C, Langslet, G, Drogari, E, Wiegman, A, Hounslow, N, Kastelein, Jj, PASCAL Study Group including Kolovou, G, Elisaf, M, Middeldorp, S, García Jiménez MC, Ponce, Ec, Di Giacomo, S, Morozzi, C, Pozzi, C, Peretti, N, Thompson, G, Mccrindle, B, Guardamagna, Ornella |
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| Přispěvatelé: | Other departments, Paediatric Metabolic Diseases, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Blood lipids Hyperlipidemias Familial hypercholesterolemia Placebo Pediatrics law.invention Dose-Response Relationship Pharmacotherapy Randomized controlled trial Double-Blind Method law Risk Factors Internal medicine Hyperlipidemia Age Factors Apolipoproteins Cardiovascular Diseases Child Cholesterol Dose-Response Relationship Drug Europe Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors Quinolines Treatment Outcome Triglycerides Pediatrics Perinatology and Child Health Medicine (all) Medicine Pitavastatin Adverse effect business.industry Perinatology and Child Health medicine.disease Physical therapy Drug business medicine.drug |
| Zdroj: | Journal of pediatrics, 167(2), 338-+. Mosby Inc. |
| ISSN: | 2011-0049 0022-3476 |
| Popis: | To assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia.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 of110 mg/dL (2.8 mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed.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 goal110 mg/dL (2.8 mmol/L). No safety issues were evident.Pitavastatin at doses up to 4 mg is well tolerated and efficacious in children and adolescents aged 6-17 years.Registered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32. |
| Databáze: | OpenAIRE |
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