Safety and Efficacy of a New Parenteral Lipid Emulsion (SMOFlipid) in Surgical Patients: A Randomized, Double-Blind, Multicenter Study

Abstract

Background/Aims: A new lipid emulsion based on soybean oil, medium chain triglycerides, olive oil and fish oil (SMOFlipid) was tested for safety, tolerance, metabolic and clinical efficacy in surgical patients. Methods: In a prospective, double-blind European multicenter study, postoperative patients (elective abdominal or thoracic surgery) were randomized to receive isonitrogenous, isoenergetic (30–35 kcal/kg) total parenteral nutrition over 5 postoperative days including either SMOFlipid^® 20% or standard soybean oil emulsion (Lipovenoes^® 20%) as lipid source (1.5 g kg^–1 day^–1). Metabolic efficacy measurements included serum levels of triglycerides (AUC), phospholipids, and total cholesterol. Safety/tolerance parameters were: hematology; clinical chemistry; coagulation profile; clinical course (arterial blood pressure, heart rate, body temperature), and documentation of adverse events. Clinical efficacy was monitored by length of hospital stay and mortality. Results: The 2 groups (per-protocol population: SMOFlipid n = 99, and Lipovenoes n = 100) were similar with respect to demographic characteristics and types of surgical intervention. Concentrations of serum triglycerides, phospholipids, and total cholesterol were comparable in both groups and within the expected ranges. Laboratory and clinical parameters were not different. A trend towards a reduced length of hospital stay was observed with SMOFlipid (15.7 ± 6.3 vs. 17.8 ± 13.2 days). Conclusions: SMOFlipid is clinically safe and well tolerated in postoperative patients. There are indications that SMOFlipid may be associated with a better liver tolerance and a shorter length of hospitalization.

Review article: the management of long‐term parenteral nutrition

“…18 An example of such a preparation is SMOFlipid, an emulsion containing soya bean, medium chain triglycerides, olive and fish oil, yielding an improved ratio of omega 3 and 6 fatty acids, which, in the acute, post-operative setting, has been associated with a better hepatic tolerance and reduced length of hospital stay. 19 Further evidence is needed to assess the advantages and disadvantages of alternative lipid emulsions in longer term HPN. Electrolytes can be delivered either in commercially available carbohydrate and amino acid solutions or may be added to PN formulations to meet individual requirements.…”

Tarm- og flerorgantransplantasjon ved kronisk tarmsvikt

“…Clinical studies have shown that fat emulsions containing a mixture of soya, coconut, olive and fish oil result in less cholestasis, particularly in children (16). Randomised studies of SMOF lipids in connection with chronic intestinal failure are taking place in Europe and the USA (17).…”

Effects unrelated to anti-inflammation of lipid emulsions containing fish oil in parenteral nutrition for adult patients

“…Several prospective studies have been published assessing the preventive effect of IVLEs containing FO on alterations in LETs or PNALD (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21). Characteristics of these studies are shown in table I.…”

“…Prospective studies collecting data on plasma clearance of IVLEs containing FO are presented in table II (6)(7)(8)(12)(13)(14)16,17,(19)(20)(21)(30)(31)(32)(33)(34).…”