Parenteral nutrition and cyclosporine: do lipids make a difference? A prospective randomized crossover trial

Aims: This prospective, controlled, randomized crossover trial was conducte d 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 ma rrow transplantation to receive isocaloric and isonitrogenous parenteral nu trition admixtures without (regimen A) or with lipids (regimen B). Admixtur es were started on average by day + 7.4; 5 patients received regimen A foll owed 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 r egimen as the sole nutrition support. At each time point, 8 whole blood sam ples were analysed for CyA to evaluate: area under the curve (AUC), trough concentration and systemic clearance. Clinical/laboratory events were recor ded until 31 months of follow-up. Results: There was no evidence of a period or treatment-by period interacti on, thus results were combined for further analysis. There were no statisti cally significant differences between regimens in any CyA pharmacokinetic p arameters; there were no significant differences from baseline values, exce pt 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 lo ng chain triglycerides did not affect CyA parameters, which were closer to baseline. In the short or long term there were no attributable side effects . (C) 2001 Harcourt Publishers Ltd.