Misoprostol in renal transplant recipients: a prospective, randomized, controlled study on the prevention of acute rejection episodes and cyclosporin A nephrotoxicity

The aim of this prospective and randomized study was to determinewhether misoprostol, an analogue of PGE1, could decrease theincidence and the number of rejection episodes and could improvethe renal function over a 12-month follow-up, when given at400 µg/day for 12 months in renal transplant patients.Given the known side-effects and the additive 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 randomizedto receive misoprostol or to receive aluminium and magnesiumhydroxide. Patients received steroids, azathioprine, antithymocyteglobulins, and cyclosporin A (CsA). CsA was randomly startedon day 0 or on day 8. At 12 months, no difference in the incidenceof rejection episodes was observed: 63.3% in the 30 patientsof the misoprostol + group versus 70.0% in the misoprostol-group(P=0.558 Mantel-Cox). The renal function, assessed by plasmacreatinine, inulin, and para-aminohippuric acid clearances,was not significantly different between misoprostol + and misoprostol-groups.No episode of CsA nephrotoxicity was observed in any patientof group one or group two. At 12 months, the mean dosage ofCsA was 4.9±0.28 mg/kg/day in the misoprostol+group versus4.52 ± 0.23 mg/kg/day in the misoprostol - group andthe trough level was not significantly different between thetwo groups. The graft survival rate at 12 months was 86.7% inthe Misoprostol+ group and 83.33% in the misoprostol- group.The trial failed to demonstrate a significant beneficial effectof misoprostol on the decrease of acute rejection episodes,on the prevention of CsA nephrotoxicity, or on the improvementof renal function over a 12-month period.