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Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hypercholesterolemia.

Abstract：

AIM:The purpose of this study was to evaluate the efficacy and safety of LIVALO tablets (pitavastatin) in Japanese male children with heterozygous familial hypercholesterolemia (FH). METHODS:A multicenter, randomized, double-blind, parallel study was conducted in 14 male children 10-15 years of age with heterozygous FH. Pitavastatin (1 mg/day or 2 mg/day) was administered orally for 52 weeks.The primary endpoint was the percent change in the LDL-cholesterol (LDL-C) concentrations from baseline to endpoint (repeated measures ANCOVA at Weeks 8 and 12). Secondary endpoints included the percentage of patients who achieved the target LDL-C concentration and percent changes in the levels of lipoprotein and lipid parameters at the visit performed at 52 weeks. RESULTS:The percent change in LDL-C from baseline (mean 258 mg/dL for all patients) to the endpoint was -27.3% (95%CI; -34.0, -20.5) and -34.3% (95%CI; -41.0, -27.5) in the patients receiving 1 mg and 2 mg of pitavastatin, respectively. Stable reductions in the total cholesterol (TC), non-HDL cholesterol (non-HDL-C), apolipoprotein B (Apo-B) and LDL-C levels and non-HDL-C/HDL-C and Apo-B/Apo-A1 ratios were observed up to 52 weeks in both groups. One patient in each dose group (14%) reached the treatment target level of 130 mg/dL.Adverse events were observed in seven (100%) patients receiving 1 mg and five (71%) patients receiving 2 mg of pitavastatin, although none were considered related to the study treatment. One patient in the 1 mg group reported a musculoskeletal AE; however, it was attributed to recent excessive exercise. CONCLUSIONS:Pitavastatin significantly reduced the LDL-C levels and was well tolerated when administered at usual adult doses in 14 male children 10-15 years of age with heterozygous FH. Pitavastatin is a promising therapeutic agent for pediatric dyslipidemia with few safety concerns.

journal_name

J Atheroscler Thromb

journal_title

Journal of atherosclerosis and thrombosis

authors

Harada-Shiba M,Arisaka O,Ohtake A,Okada T,Suganami H,NK-104-PH 01 study registration group.

doi

10.5551/jat.28753

subject

Has Abstract

pub_date

2016-01-01 00:00:00

pages

48-55

issue

eissn

1340-3478

issn

1880-3873

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hypercholesterolemia.