Randomized trial of misoprostol in patients with chronic renal transplant rejection

Chronic vascular rejection is a major cause of long-term graft failure after renal transplantation. We investigated the effect of the addition of misoprostol (200 micrograms four times daily) to standard immunosuppressive therapy on the outcome of chronic rejection in a double-blind, placebo-controlled trial. Patients had to fulfill predefined histological and clinical criteria. After an entry of 40 patients into the study (22 misoprostol, 18 placebo), the inclusion of additional patients was terminated because of a high incidence of withdrawal due to adverse effects. Of the patients who used their study medication for at least 3 months (16 misoprostol, 15 placebo), graft function deteriorated in all but 5 misoprostol-treated and all but 2 placebo-treated patients. There was no difference in dialysis-free survival. Withdrawal because of adverse effects (mainly gastrointestinal complaints) occurred in 3 cases in the placebo group and in 11 cases in the misoprostol group (P < 0.05). In conclusion, we found no evidence for a beneficial effect of misoprostol on the course of chronic renal allograft rejection, while use of the drug was accompanied by a high incidence of side effects.