Trial reportJournal of atherosclerosis and thrombosis2018
Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hypercholesterolemia in Japan and Europe.
Trial report in Journal of atherosclerosis and thrombosis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Pitavastatin for lowering lipids.The Cochrane database of systematic reviews · 2020 · on this mapPooled it
- Statins for children with familial hypercholesterolemia.The Cochrane database of systematic reviews · 2019Pooled it
- Transitioning Adolescents and Young Adults with Lipid Disorders to Adult Health Care.Current atherosclerosis reports · 2024Review
- Familial Hypercholesterolaemia as a Predisposing Factor for Atherosclerosis.Biomedicines · 2022Review
- Review
- Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection.Clinical pharmacokinetics · 2020Review
- HMG-CoA Reductase Inhibitors as Drug Leads againstACS chemical neuroscience · 2020Article
- Dyslipidemia and cardiovascular health in childhood nephrotic syndrome.Pediatric nephrology (Berlin, Germany) · 2020 · on this mapReview
- The Knowns and Unknowns of Contemporary Statin Therapy for Familial Hypercholesterolemia.Current atherosclerosis reports · 2020Review
- Familial hypercholesterolaemia: evolving knowledge for designing adaptive models of care.Nature reviews. Cardiology · 2020Review
- Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up.Cardiovascular diabetology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimChildren with Familial Hypercholesterolemia (FH) are widely prescribed statins, and it has been suggested that the effects of statins differ among ethnicities. We compared the efficacy and safety of pitavastatin in children and adolescents with FH in clinical trials conducted in Japan and Europe.
methodsLow-density lipoprotein cholesterol (LDL-C) reductions, adjusted for confounding factors, and safety were compared between the studies in Japan and Europe. In the Japanese study, 14 males with heterozygous FH, aged 11.8±1.6 years, were randomized to 52-week double-blind treatment with 1 or 2 mg/day pitavastatin. In the European study, 106 children and adolescents with high risk hyperlipidemia (103 heterozygous FH), aged 10.6±2.9 years, were randomized to 12-week double-blind treatment with 1, 2 or 4 mg/day pitavastatin or placebo; 84 of these patients and 29 new patients participated in a 52-week open-label extension study.
resultsAge, body weight and baseline LDL-C were identified as factors influencing LDL-C reduction. There were no significant differences in the adjusted mean percentage reduction in LDL-C in Japanese and European children by pitavastatin (24.5% and 23.6%, respectively at 1 mg/day and 33.5% and 30.8%, respectively at 2 mg/day). Pitavastatin was well tolerated without any difference in the frequency or nature of adverse events between the treatment groups, or between the studies.
conclusionThere were no significant differences between the efficacy or safety of pitavastatin in Japanese and European children and adolescents with FH, suggesting no relevant ethnic differences in the safety or efficacy of pitavastatin.
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Registered trials
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