ENISOPROST IN LIVER-TRANSPLANTATION

Previous human studies in renal transplant recipients have shown a low er incidence of acute rejection and cyclosporine-associated acute neph rotoxicity when prostaglandins are administered in conjunction with st andard immunosuppressants. This study evaluates the effects of enisopr ost (EP), a synthetic PGE methyl ester analog, in a single-center, pro spective, randomized, double-blind, placebo-controlled, parallel group trial in 81 consecutive adult patients undergoing orthotopic liver tr ansplantation (OLT), The subjects received EP 100 mg p.o, t,i,d, (n=40 ) or placebo (n=41) for the first 12 weeks after OLT, Immunosuppressio n was based on cyclosporine, azathioprine, and corticosteroids, Effect ive renal plasma flow and glomerular filtration rate were determined a t 4 and 12 weeks after OLT. Eighty-one patients entered the study; six ty-six patients completed the 16-week study period, There were no stat istically significant differences between EP- and placebo-treated grou ps at 12 weeks for creatinine clearance, glomerular filtration rate, a nd effective renal plasma flow, At least 1 episode of cyclosporine nep hrotoxicity occurred in 7/40 patients (17.5%) in the EP group compared with 9/41 patients (20.0%) in the placebo group (P=0.781), There was no significant difference in the incidence of graft rejection episodes in the 2 groups, Enisoprost, as used in this study, does not have any beneficial effect on renal function or incidence of rejection in OLT recipients.