title: Lack of a renal-protective effect of misoprostol in rheumatoid arthritis patients receiving cyclosporin A. Results of a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  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 micrograms/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 mg/kg/day 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.
  
  
  CONCLUSIONS
  A renal-protective effect was not demonstrated for misoprostol compared with placebo in RA patients who are beginning CSA therapy.
authors.affiliation: Brigham and Women's Hospital, Boston, MA 02115.
authors.forename: M E
authors.initials: ME
authors.lastname: Weinblatt
authors.forename: B F
authors.initials: BF
authors.lastname: Germain
authors.forename: J M
authors.initials: JM
authors.lastname: Kremer
authors.forename: B A
authors.initials: BA
authors.lastname: Wall
authors.forename: M H
authors.initials: MH
authors.lastname: Weisman
authors.forename: A L
authors.initials: AL
authors.lastname: Maier
authors.forename: J S
authors.initials: JS
authors.lastname: Coblyn
mesh_terms: D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D007668:Kidney / Q000187:drug effects*; D007674:Kidney Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011446:Prospective Studies
chemical_list: D010919:Placebos; D016595:Misoprostol; D016572:Cyclosporine