Oral Tocofersolan Corrects or Prevents Vitamin E Deficiency in Children with Chronic Cholestasis.

Background/Aims: d-alpha-tocopheryl polyethylene glycol 1000 succinate (Tocofersolan, Vedrop(R)), has been developed in Europe to provide an orally bioavailable source of vitamin E in children with cholestasis. The aim was to analyze the safety/efficacy of Vedrop(R) in a large group of children with chronic cholestasis. Methods: 274 Children receiving Vedrop(R) for vitamin E deficiency or for its prophylaxis were included from 7 European centers. Median age at treatment onset was 2 months and median follow-up was 11 months. Vedrop(R) was prescribed at a daily dose of 0.34 ml/kg (25 IU/kg) of body weight. Three methods were used to determine a sufficient serum vitamin E status: vitamin E; vitamin E/(total cholesterol); vitamin E/(total cholesterol + triglycerides). Results: Before Vedrop(R) therapy, 51% of children had proven vitamin E deficiency, 30% had normal vitamin E status and 19% had an unknown vitamin E status. During the first months of treatment, vitamin E status was restored in the majority of children with insufficient levels at baseline (89% had a normal status at 6 months). All children with a normal baseline vitamin E status had a normal vitamin E status at 6 months. Among children with an unknown vitamin E status at baseline, 93% had a normal vitamin E status at 6 months. A sufficient vitamin E status was observed in 80% of children with significant cholestasis (serum total bilirubin > 34.2 [mu]mol/L). No serious adverse reaction was reported. Conclusions: Vedrop(R) seems a safe and effective oral formulation of vitamin E that restores and/or maintains sufficient serum vitamin E level in the majority of children with cholestasis, avoiding the need for intramuscular vitamin E injections. (C) 2016 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

from Gastroenterology via xlomafota13 on Inoreader http://ift.tt/29WO92a
via IFTTT