Parenteral nutrition and cyclosporine: do lipids make a difference? A prospective randomized crossover trial.
OBJECTIVE
This prospective, controlled, randomized crossover trial was conducted to assess the effects of parenteral nutrition, with or without lipids, in cyclosporine (CyA) pharmacokinetics.


METHODS
10 adult patients were randomized on the day of allogeneic bone marrow transplantation to receive isocaloric and isonitrogenous parenteral nutrition admixtures without (regimen A) or with lipids (regimen B). Admixtures were started on average by day + 7.4; 5 patients received regimen A followed by B, 5 in reverse order. Blood samples were collected at day 4 after transplantation, under oral diet, and 4 days after the initiation of each regimen as the sole nutrition support. At each time point, 8 whole blood samples were analysed for CyA to evaluate: area under the curve (AUC), trough concentration and systemic clearance. Clinical/laboratory events were recorded until 31 months of follow-up.


RESULTS
There was no evidence of a period or treatment-by period interaction, thus results were combined for further analysis. There were no statistically significant differences between regimens in any CyA pharmacokinetic parameters; there were no significant differences from baseline values, except for a higher systemic clearance of CyA with regimen A (0.40+/-0.09 vs 0.29+/-0.06 L/Kg/h, p=0.03).


CONCLUSIONS
The provision of 0.8 g/Kg/d of a 50:50 mixture of medium and long chain triglycerides did not affect CyA parameters, which were closer to baseline. In the short or long term there were no attributable side effects.
Santos
P
P
Center of Nutrition and Metabolism, University Hospital of Santa Maria, Av. Egas Moniz, 1649-028 Lisboa, Portugal.
Lourenço
R
R
Camilo
M E
ME
Oliveira
A G
AG
Figueira
I
I
Pereira
M E
ME
Ferreira
B
B
Carmo
J A
JA
Lacerda
J M
JM
D000328:Adult; D019540:Area Under Curve; D016026:Bone Marrow Transplantation; D018592:Cross-Over Studies; D016572:Cyclosporine / Q000097:blood / Q000493:pharmacokinetics*; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D011446:Prospective Studies
D005217:Fat Emulsions, Intravenous; D007166:Immunosuppressive Agents; D016572:Cyclosporine