DELAYED OMEGA-3-FATTY-ACID SUPPLEMENTS IN RENAL-TRANSPLANTATION - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

An earlier reported trial suggests that omega-3 fatty acids in fish oi l supplements at 6 g/day with administration commencing at the time of engraftment may reduce acute CsA renal dysfunction. When started at t he time of renal transplant, there are improvements in renal hemodynam ics and blood pressure, and a decrease in rejection episodes. To exami ne the effect of later introduction of omega-3 fatty acids, 133 cadave r renal transplant recipients received CsA, prednisone, and AZA for 16 weeks (period 1). If patients were stable without rejection or infect ion activity, they were randomized to 9 g of eicosapentanoic acid (EPA ), 18 g of EPA, 9 g of corn oil, or 18 g of corn oil in l-g capsules a s supplements. Glomerular filtration rate, renal blood flow, number of rejection episodes, blood pressure, and episodes of CsA nephrotoxicit y were followed for 26 weeks in a double-blind manner (period 2). Nine ty patients were evaluable and completed the protocol. There were 50 c orn oil placebo patients, 22 low dose EPA patients, and 18 high dose E PA patients. In period 1, there were 27 rejection episodes in 21 patie nts without differences among subsequent treatment groups. In period 2 , there were 13 rejection episodes in 4 patients. No patient with an E PA level in plasma statistically higher than placebo had a rejection e pisode. All allografts functioned for the entire 6 months with none lo st to rejection. All 5 episodes of acute CsA nephrotoxicity occurred i n placebo-treated patients without differences in whole blood CsA amon g toxic patients, other placebo patients, and EPA-treated recipients. At the end of the study, there were no differences in glomerular filtr ation rate, renal blood flow, or creatinine clearance among groups. Di astolic blood pressure fell by 9 mmHg during period 2 in high dose fis h oil recipients and by 10 mmHg in low dose fish oil recipients (P<0.0 5), while it rose by 2 mmHg in placebo patients. No serious adverse ef fects of EPA supplements were noted, although compliance based on plas ma EPA was erratic. Based on our experience and that in the literature , administration of omega-3 fatty acids for purposes of kidney protect ion would seem to be most useful when started early after surgery. Lat e administration in our study was associated with minor clinical benef its.