LACK OF A RENAL-PROTECTIVE EFFECT OF MISOPROSTOL IN RHEUMATOID-ARTHRITIS PATIENTS RECEIVING CYCLOSPORINE-A - RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Objective. To assess whether the synthetic prostaglandin misoprostol i s renal protective in rheumatoid arthritis (RA) patients who are begin ning cyclosporin A (CSA) therapy. Methods. In this randomized, placebo -controlled, multicenter trial, 50 patients with active RA were random ized to receive either misoprostol (800 mu g/day) or placebo for 16 we eks. After 2 weeks of pretreatment with misoprostol or placebo, all pa tients concomitantly received CSA at an initial and maximum dosage of 5 mg/kg/day for 12 weeks. Results. A significant increase in the serum creatinine level was observed in both treatment groups, with no diffe rence noted between groups. There was a high withdrawal rate in both g roups, primarily due to adverse events. Conclusion. A renal-protective effect was not demonstrated for misoprostol compared with placebo in RA patients who are beginning CSA therapy.