Enisoprost in liver transplantation.
Previous human studies in renal transplant recipients have shown a lower incidence of acute rejection and cyclosporine-associated acute nephrotoxicity when prostaglandins are administered in conjunction with standard immunosuppressants. This study evaluates the effects of enisoprost (EP), a synthetic PGE methyl ester analog, in a single-center, prospective, randomized, double-blind, placebo-controlled, parallel group trial in 81 consecutive adult patients undergoing orthotopic liver transplantation (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. Immunosuppression was based on cyclosporine, azathioprine, and corticosteroids. Effective renal plasma flow and glomerular filtration rate were determined at 4 and 12 weeks after OLT. Eighty-one patients entered the study; sixty-six patients completed the 16-week study period. There were no statistically significant differences between EP- and placebo-treated groups at 12 weeks for creatinine clearance, glomerular filtration rate, and effective renal plasma flow. At least 1 episode of cyclosporine nephrotoxicity 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.
Ismail
T
T
Liver Unit, Queen Elizabeth Hospital, Birmingham, United Kingdom.
Ayres
R
R
Kiff
P
P
McMaster
P
P
Neuberger
J
J
D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016572:Cyclosporine / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007668:Kidney / Q000187:drug effects / Q000503:physiopathology; D007677:Kidney Function Tests; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000527:Alprostadil; C054594:enisoprost