Marjet J A M Braamskamp1, Claudia Stefanutti2, Gisle Langslet3, Euridiki Drogari4, Albert Wiegman5, Neil Hounslow6, John J P Kastelein7. 1. 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. 2. Extracorporeal Therapeutic Techniques Unit, Lipid Clinic and Atherosclerosis Prevention Center, Department of Molecular Medicine, 'Sapienza' University of Rome, 'Umberto I' Hospital, Rome, Italy. 3. Lipid Clinic, Oslo University Hospital, Oslo, Norway. 4. Unit on Metabolic Diseases, Choremio Research Laboratory, University of Athens, 1st Department of Pediatrics, Aghia Sophia Children's Hospital, Athens, Greece. 5. Department of Pediatrics, Academic Medical Center, Amsterdam, The Netherlands. 6. Kowa Research Europe Ltd, Wokingham, United Kingdom. 7. Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
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 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.
RCT Entities:
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 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.
Authors: Alpo Vuorio; Jaana Kuoppala; Petri T Kovanen; Steve E Humphries; Serena Tonstad; Albert Wiegman; Euridiki Drogari; Uma Ramaswami Journal: Cochrane Database Syst Rev Date: 2017-07-07
Authors: Alpo Vuorio; Jaana Kuoppala; Petri T Kovanen; Steve E Humphries; Serena Tonstad; Albert Wiegman; Euridiki Drogari; Uma Ramaswami Journal: Cochrane Database Syst Rev Date: 2019-11-07