Lack of a renal-protective effect of misoprostol in rheumatoid arthritis patients receiving cyclosporin A. Results of a randomized, placebo-controlled trial.
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.
Weinblatt
M E
ME
Brigham and Women's Hospital, Boston, MA 02115.
Germain
B F
BF
Kremer
J M
JM
Wall
B A
BA
Weisman
M H
MH
Maier
A L
AL
Coblyn
J S
JS
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
D010919:Placebos; D016595:Misoprostol; D016572:Cyclosporine