Lack of a renal–protective effect of misoprostol in rheumatoid arthritis patients receiving cyclosporin a. results of a randomized, placebo–controlled trial

✍ Scribed by Michael E. Weinblatt; Bernard F. Germain; Joel M. Kremer; Bruce A. Wall; Michael H. Weisman; Agnes L. Maier; Jonathan S. Coblyn

• Publisher: John Wiley and Sons
• Year: 1994
• Tongue: English
• Weight: 469 KB
• Volume: 37
• Category: Article
• ISSN: 0004-3591
• DOI: 10.1002/art.1780370908

✦ Synopsis

To assess whether the synthetic prostaglandin misoprostol is renal protective in rheumatoid arthritis (RA) patients who are beginning cyclosporin A (CSA) therapy.

Methods. In this randomized, placebo-controlled, multicenter trial, 50 patients with active RA were randomized to receive either misoprostol (800 pg/day) or placebo for 16 weeks. After 2 weeks of pretreatment with misoprostol or placebo, all patients concomitantly received CSA at an initial and maximum dosage of 5 mgkglday for 12 weeks.

Results. A significant increase in the serum creatinine level was observed in both treatment groups, with no difference noted between groups. There was a high withdrawal rate in both groups, 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.

Cyclosporin A (CSA) has been used for the therapy of active rheumatoid arthritis (RA) (l,Z), and renal dysfunction has been identified as an important toxicity associated with this treatment. Lower doses Supported by a grant from Searle Pharmaceuticals.