One-year Experience With Composite Intravenous Lipid Emulsion in Children on Home Parenteral Nutrition.
Journal
Journal of pediatric gastroenterology and nutrition
ISSN: 1536-4801
Titre abrégé: J Pediatr Gastroenterol Nutr
Pays: United States
ID NLM: 8211545
Informations de publication
Date de publication:
01 03 2021
01 03 2021
Historique:
pubmed:
3
12
2020
medline:
22
6
2021
entrez:
2
12
2020
Statut:
ppublish
Résumé
Composite lipid emulsion (CLE) composed of soybean oil, medium-chain triglycerides, olive oil, and fish oil is approved in the US for parenterally fed adults. For stable children discharged on home parenteral nutrition (HPN) without cholestasis (direct bilirubin > 2.0 mg/dL), CLE has theoretical benefits over soybean-based intravenous lipid emulsion due to reduced phytosterol exposure with higher calorie support to permit reduced glucose infusion rates (GIRs), omega-3 supplementation, and supplemental α-tocopherol. In this prospective, single-center open-label research study, safety and efficacy outcomes were evaluated in patients on HPN younger than 18 years treated with CLE at 1 to 3 g · kg-1 · day-1 over 12 months. The primary outcome was change in anthropometrics and GIRs compared with baseline. Secondary outcomes were changes in fatty acid profiles and liver function and enzyme tests compared with baseline. Fifty-seven subjects were treated with a median age of 7 years. The diagnosis was short bowel syndrome in 72%. Change in practice was associated with a decrease in mean GIRs from 17 to 14 mg · kg-1 · h-1 at 4 to 6 months postbaseline and beyond with a coincidental decline in mean arachidonic acid and stable growth parameters. No significant adverse events were noted. CLE was safe and well-tolerated in stable children on HPN at 1 year, but further studies are needed in this population to appreciate long-term outcomes.
Sections du résumé
BACKGROUND
Composite lipid emulsion (CLE) composed of soybean oil, medium-chain triglycerides, olive oil, and fish oil is approved in the US for parenterally fed adults. For stable children discharged on home parenteral nutrition (HPN) without cholestasis (direct bilirubin > 2.0 mg/dL), CLE has theoretical benefits over soybean-based intravenous lipid emulsion due to reduced phytosterol exposure with higher calorie support to permit reduced glucose infusion rates (GIRs), omega-3 supplementation, and supplemental α-tocopherol.
METHODS
In this prospective, single-center open-label research study, safety and efficacy outcomes were evaluated in patients on HPN younger than 18 years treated with CLE at 1 to 3 g · kg-1 · day-1 over 12 months. The primary outcome was change in anthropometrics and GIRs compared with baseline. Secondary outcomes were changes in fatty acid profiles and liver function and enzyme tests compared with baseline.
RESULTS
Fifty-seven subjects were treated with a median age of 7 years. The diagnosis was short bowel syndrome in 72%. Change in practice was associated with a decrease in mean GIRs from 17 to 14 mg · kg-1 · h-1 at 4 to 6 months postbaseline and beyond with a coincidental decline in mean arachidonic acid and stable growth parameters. No significant adverse events were noted.
CONCLUSIONS
CLE was safe and well-tolerated in stable children on HPN at 1 year, but further studies are needed in this population to appreciate long-term outcomes.
Identifiants
pubmed: 33264184
pii: 00005176-202103000-00024
doi: 10.1097/MPG.0000000000003011
doi:
Substances chimiques
Fat Emulsions, Intravenous
0
Fish Oils
0
Olive Oil
0
Triglycerides
0
Soybean Oil
8001-22-7
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
451-455Subventions
Organisme : FDA HHS
ID : R01 FD003436
Pays : United States
Informations de copyright
Copyright © 2020 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
Références
Boullata JI, Gilbert K, Sacks G, et al. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr 2014; 38:334–377.
Tashiro T, Ogata H, Yokoyama H, et al. The effect of fat emulsion (Intralipid) on essential fatty acid deficiency in infants receiving intravenous alimentation. J Pediatr Surg 1976; 11:505–515.
Postuma R, Pease PW, Watts R, et al. Essential fatty acid deficiency in infants receiving parenteral nutrition. J Pediatr Surg 1978; 13:393–398.
Carter BA, Taylor OA, Prendergast DR, et al. Stigmasterol, a soy lipid-derived phytosterol, is an antagonist of the bile acid nuclear receptor FXR. Pediatr Res 2007; 62:301–306.
Tazuke Y, Teitelbaum DH. Alteration of canalicular transporters in a mouse model of total parenteral nutrition. J Pediatr Gastroenterol Nutr 2009; 48:193–202.
Kurvinen A, Nissinen MJ, Andersson S, et al. Parenteral plant sterols and intestinal failure-associated liver disease in neonates. J Pediatr Gastroenterol Nutr 2012; 54:803–811.
Fresenius Kabi. “Fresenius Kabi Launches Smoflipid® in the United States.” August 2018. Available at: https://www.fresenius-kabi.com/us/news/fresenius-kabi-launches-smoflipid-in-the-united-states . Accessed December 1, 2020.
Cober MP, Teitelbaum DH. Prevention of parenteral nutrition-associated liver disease: lipid minimization. Curr Opin Organ Transplant 2010; 15:330–333.
Colomb V, Jobert-Giraud A, Lacaille F, et al. Role of lipid emulsions in cholestasis associated with long-term parenteral nutrition in children. JPEN J Parenter Enteral Nutr 2000; 24:345–350.
Lam G, Strogach IG, Baron N, et al. Normal growth and essential fatty acid status in children with intestinal failure on lipid limitation. J Pediatr Gastroenterol Nutr 2016; 62:335–340.
Grimm H, Mertes N, Goeters C, et al. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr 2006; 45:55–60.
Goulet O, Antebi H, Wolf C, et al. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr 2010; 34:485–495.
Lam CKL, Church PC, Haliburton B, et al. Long-term exposure of children to a mixed lipid emulsion is less hepatotoxic than soybean-based lipid emulsion. J Pediatr Gastroenterol Nutr 2018; 66:501–504.
Repa A, Binder C, Thanhaeuser M, et al. A mixed lipid emulsion for prevention of parenteral nutrition associated cholestasis in extremely low birth weight infants: a randomized clinical trial. J Pediatr 2018; 194:87.e81–93.e81.
Ho BE, Chan SC, Faino AV, et al. Evaluation of SMOFlipid in pediatric intestinal-failure patients and its effects on essential fatty acid levels. JPEN J Parenter Enteral Nutr 2020; May 15. Epub ahead of print.
Tripp MG, Menon SK, Mikrut BA. Stability of total nutrient admixtures in a dual-chamber flexible container. Am J Hosp Pharm 1990; 47:2496–2503.
Hurvich CM, Tsai C-L. Regression and time series model selection in small samples. Biometrika 1989; 76:297–307.
Blom G. Statistical Estimates and Transformed Beta Variables. New York, NY: John Wiley & Sons, Inc; 1958.
Baker MA, Mitchell PD, O’Loughlin AA, et al. Characterization of fatty acid profiles in infants with intestinal failure-associated liver disease. JPEN J Parenter Enteral Nutr 2018; 42:71–77.
Memon N, Hussein K, Hegyi T, et al. Essential fatty acid deficiency with SMOFlipid reduction in an infant with intestinal failure-associated liver disease. JPEN J Parenter Enteral Nutr 2019; 43:438–441.
Carey AN, Rudie C, Mitchell PD, et al. Essential fatty acid status in surgical infants receiving parenteral nutrition with a composite lipid emulsion: a case series. JPEN J Parenter Enteral Nutr 2019; 43:305–310.
Moon HJ, Hwang IW, Lee JW, et al. A case of fat overload syndrome after rapid infusion of SMOFlipid emulsion in an adult. Am J Emerg Med 2017; 35:660.e663–660.e664.
Hojsak I, Kolacek S. Fat overload syndrome after the rapid infusion of SMOFlipid emulsion. JPEN J Parenter Enteral Nutr 2014; 38:119–121.
Winkler MF, DiMaria-Ghalili RA, Guenter P, et al. Characteristics of a cohort of home parenteral nutrition patients at the time of enrollment in the sustain registry. JPEN J Parenter Enteral Nutr 2016; 40:1140–1149.
Raphael BP, Murphy M, Gura KM, et al. Discrepancies between prescribed and actual pediatric home parenteral nutrition solutions. Nutr Clin Pract 2016; 31:654–658.
Raphael BP, Duggan C. Prevention and treatment of intestinal failure-associated liver disease in children. Semin Liver Dis 2012; 32:341–347.
Belza C, Thompson R, Somers GR, et al. Persistence of hepatic fibrosis in pediatric intestinal failure patients treated with intravenous fish oil lipid emulsion. J Pediatr Surg 2017; 52:795–801.
Van Gossum A, Pironi L, Messing B, et al. Transient elastography (FibroScan) is not correlated with liver fibrosis but with cholestasis in patients with long-term home parenteral nutrition. JPEN J Parenter Enteral Nutr 2015; 39:719–724.