Enteric-coated cysteamine for the treatment of paediatric non-alcoholic fatty liver disease

Autor:	R, Dohil, S, Schmeltzer, B L, Cabrera, T, Wang, J, Durelle, K B, Duke, J B, Schwimmer, J E, Lavine
Rok vydání:	2011
Předmět:	Male Adolescent Cysteamine Body Weight Pilot Projects Antioxidants Body Mass Index Fatty Liver Oxidative Stress Treatment Outcome Non-alcoholic Fatty Liver Disease Humans Female Adiponectin Tablets Enteric-Coated Insulin Resistance Child Transaminases
Zdroj:	Alimentary pharmacologytherapeutics. 33(9)
ISSN:	1365-2036
Popis:	Non-alcoholic fatty liver disease (NAFLD) is a common cause of liver disease in children. Hepatic fat accumulation and oxidative stress contribute to its pathogenesis. Cysteamine bitartrate readily traverses cellular membranes and is a potent antioxidant.To evaluate the safety and efficacy of enteric-coated (EC) cysteamine in children with NAFLD.Children, aged ≥10 y, meeting screening criteria with biopsy-proven NAFLD and serum ALT ≥60 IU/L, received twice-daily EC-cysteamine for 24 weeks. Monthly ALT, AST, body mass index (BMI) and gastrointestinal symptom scores were measured. Subjects with50% reduction or normalisation of ALT achieved the primary endpoint.Of the 13 children enrolled (mean age 14.0 years), 11 completed EC-cysteamine therapy (mean dose 15.2 mg/kg/day) and were included in the final analysis. For these 11 subjects, the mean ALT levels at baseline and 24 weeks were 120.2 and 55 IU/L respectively (P = 0.002), and the AST levels were 60 and 36 IU/L respectively (P = 0.007). The primary endpoint was reached in 7 and normalisation (≤40 IU/L) of ALT in 5. After 24 week therapy, mean adiponectin levels increased (P = 0.009) and CK-18 fragment levels decreased (P = 0.013), insulin levels remained unchanged (P = 0.99). Mean leptin levels were decreased in responders (P = 0.044). Mean BMI was 34.5 at baseline and 34.2 kg/m(2) after treatment (P = 0.35). Mean symptom scores at baseline (1.1) and at 24 weeks (0.7) were similar. No major adverse events were reported.Enteric-coated cysteamine reduces ALT and AST levels in children with NAFLD without reduction in body mass index. Further studies will evaluate optimal cysteamine therapeutic dose and effect on liver histology in NAFLD (Clinicaltrials.gov protocol ID: 07-1699).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid________::0068bd474c8234a02fcd1473cf1226cf https://pubmed.ncbi.nlm.nih.gov/21395631 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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