کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6220479 | 1607440 | 2015 | 11 صفحه PDF | دانلود رایگان |
ObjectivesTo assess the safety and efficacy of pitavastatin in children and adolescents with hyperlipidemia.Study designA total of 106 children and adolescents with hyperlipidemia, ages 6 to 17Â years, were enrolled in a 12-week randomized, double-blind, placebo-controlled study and randomly assigned to pitavastatin 1Â mg, 2Â mg, 4Â mg, or placebo. During a 52-week extension period, subjects were up-titrated from 1Â mg pitavastatin to a maximum dose of 4Â mg in an effort to achieve an optimum low-density lipoprotein cholesterol (LDL-C) treatment target of <110Â mg/dL (2.8Â mmol/L). Adverse events rates, including abnormal clinical laboratory variables, vital signs, and physical examination were assessed.ResultsCompared with placebo, pitavastatin 1, 2, and 4Â 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 <110Â mg/dL (2.8Â mmol/L). No safety issues were evident.ConclusionsPitavastatin at doses up to 4Â mg is well tolerated and efficacious in children and adolescents aged 6-17Â years.Trial registrationRegistered with EudraCT 2011-004964-32 and EudraCT 2011-004983-32.
Journal: The Journal of Pediatrics - Volume 167, Issue 2, August 2015, Pages 338-343.e5