Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults.
CONCLUSIONS
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 containing four different types of oils is safe and well tolerated in long-term PN.


OBJECTIVE
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 = 34) or soybean emulsion (Intralipid, control n = 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 phospholipids 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, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 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 = 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.
Jagiellonian University Medical College, Krakow, Poland.
Stanislaw
S
Klek
Cecile
C
Chambrier
Pierre
P
Singer
Moshe
M
Rubin
Tim
T
Bowling
Michael
M
Staun
Francisca
F
Joly
Henrik
H
Rasmussen
Boyd J
BJ
Strauss
Geert
G
Wanten
Ross
R
Smith
Arun
A
Abraham
Kinga
K
Szczepanek
Jon
J
Shaffer
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D004281:Docosahexaenoic Acids / Q000097:blood; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000097:blood; D004655:Emulsions / Q000008:administration & dosage; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage*; D043371:Fatty Acids, Omega-6 / Q000097:blood; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D000069463:Olive Oil; D010288:Parenteral Nutrition / Q000009:adverse effects*; D057947:Parenteral Nutrition Solutions / Q000008:administration & dosage*; D010743:Phospholipids / Q000008:administration & dosage*; D010938:Plant Oils / Q000008:administration & dosage; D018124:Receptors, Tumor Necrosis Factor / Q000097:blood; D013024:Soybean Oil / Q000008:administration & dosage*; D014280:Triglycerides / Q000008:administration & dosage; D014810:Vitamin E / Q000008:administration & dosage / Q000097:blood; D055815:Young Adult
D004655:Emulsions; D005217:Fat Emulsions, Intravenous; D043371:Fatty Acids, Omega-6; D005395:Fish Oils; D015850:Interleukin-6; D000069463:Olive Oil; D057947:Parenteral Nutrition Solutions; D010743:Phospholipids; D010938:Plant Oils; D018124:Receptors, Tumor Necrosis Factor; D014280:Triglycerides; C545823:soybean oil, phospholipid emulsion; D014810:Vitamin E; D004281:Docosahexaenoic Acids; D013024:Soybean Oil; D015118:Eicosapentaenoic Acid; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D001663:Bilirubin