Original article Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid) e A double-blind, randomised, multicentre study in adults Stanislaw Klek a , Cecile Chambrier b , Pierre Singer c , Moshe Rubin c , Tim Bowling d , Michael Staun e , Francisca Joly f , Henrik Rasmussen g , Boyd J. Strauss h , Geert Wanten i , Ross Smith j , Arun Abraham k , Kinga Szczepanek a , Jon Shaffer k, * a Jagiellonian University Medical College, Krakow, Poland b Hopital de la Croix Rousse, Lyon, France c Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel d University Hospital, Nottingham, UK e Rigshospitalet, Copenhagen, Denmark f Hopital Beaujon, Clichy la Garenne, France g Aalborg University Hospital, Aalborg, Denmark h Monash Medical Centre, Monash University, Melbourne, Australia i University Medical Center Nijmegen, Netherlands j North Shore Private Hospital, Saint Leonards, Australia k Salford Royal NHS Foundation Trust, Intestinal Failure Unit, Salford M68HD, UK article info Article history: Received 12 September 2011 Accepted 20 June 2012 Keywords: Lipid emulsions Long-term intestinal failure Parenteral nutrition SMOFlipid Liver function Short bowel syndrome summary Precis: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion con- taining four different types of oils is safe and well tolerated in long-term PN. Background & aim: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium- chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). Methods: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n ¼ 34) or soybean emulsion (Intralipid, control n ¼ 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phos- pholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s- TNF)-receptor(R)II were also evaluated. Results: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/ fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, doco- sahexaenoic acid and nÀ3/nÀ6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum a-tocopherol concentrations significantly increased in the study group compared to control (p ¼ 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p ¼ 0.03). Conclusions: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile. Ó 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. 1. Introduction Intravenous lipid emulsions are an essential component of parenteral nutrition (PN) regimens, representing a major source of energy and essential fatty acids (FAs). 1 Intralipid, the first * Corresponding author. E-mail address: jon.shaffer@srft.nhs.uk (J. Shaffer). Contents lists available at SciVerse ScienceDirect Clinical Nutrition journal homepage: http://www.elsevier.com/locate/clnu 0261-5614/$ e see front matter Ó 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved. http://dx.doi.org/10.1016/j.clnu.2012.06.011 Clinical Nutrition 32 (2013) 224e231