MISOPROSTOL IN RENAL-TRANSPLANT RECIPIENTS - A PROSPECTIVE, RANDOMIZED, CONTROLLED-STUDY ON THE PREVENTION OF ACUTE REJECTION EPISODES AND CYCLOSPORINE-A NEPHROTOXICITY

The aim of this prospective and randomized study was to determine whet her misoprostol, an analogue of PGE1, could decrease the incidence and the number of rejection episodes and could improve the renal function over a 12-month follow-up, when given at 400 mug/day for 12 months in renal transplant patients. Given the known side-effects and the addit ive cost of misoprostol, a benefit of the therapy should be a decrease of at least 50% in the incidence of rejection episodes in the treated group. Therefore, 60 consecutive renal transplant patients were rando mized to receive misoprostol or to receive aluminium and magnesium hyd roxide. Patients received steroids, azathioprine, antithymocyte globul ins, and cyclosporin A (CsA). CsA was randomly started on day 0 or on day 8. At 12 months, no difference in the incidence of rejection episo des was observed: 63.3% in the 30 patients of the misoprostol+ group v ersus 70.0% in the misoprostol- group (P = 0.558 Mantel-Cox). The rena l function, assessed by plasma creatinine, inulin, and para-aminohippu ric acid clearances, was not significantly different between misoprost ol+ and misoprostol- groups. No episode of CsA nephrotoxicity was obse rved in any patient of group one or group two. At 12 months, the mean dosage of CsA was 4.9 +/- 0.28 mg/kg/day in the misoprostol+ group ver sus 4.52 +/- 0.23 mg/kg/day in the misoprostol- group and the trough l evel was not significantly different between the two groups. The graft survival rate at 12 months was 86.7% in the Misoprostol+ group and 83 .33% in the misoprostol- group. The trial failed to demonstrate a sign ificant beneficial effect of misoprostol on the decrease of acute reje ction episodes, on the prevention of CsA nephrotoxicity, or on the imp rovement of renal function over a 12-month period.