Effect of misoprostol on ibuprofen-induced renal dysfunction in patients with decompensated cirrhosis: results of a double-blind placebo-controlled parallel group study.

OBJECTIVES: Patients with cirrhosis are prone to develop renal failure upon administration of nonsteroidal anti-inflammatory drugs. The aim of the present study was to determine the safety and efficacy of misoprostol (400 microg) in two repeated doses for the prevention of ibuprofen-induced decrements in renal function in decompensated cirrhotics.
METHODS: Patients were given ibuprofen (800 mg) with either misoprostol (n = 9) or a placebo (n = 10). Sixty minutes later another dose of misoprostol or the placebo was administered. Renal function tests were assessed by clearance techniques.
RESULTS: Administration of ibuprofen with a placebo caused significant decreases in urinary output, inulin clearance, sodium excretion, osmolar clearance, free water clearance, and urinary prostaglandin E2 excretion. Coadministration of ibuprofen and the first misoprostol dose maintained urinary output and sodium excretion, and caused an increase in free water clearance. These changes were maintained only for 1 h. Administration of the second dose of misoprostol temporarily improved inulin and creatinine clearances. Half the patients who received misoprostol suffered from episodes of chills, fever, and diarrhea.
CONCLUSION: Ibuprofen causes renal dysfunction in decompensated cirrhotics, whereas misoprostol may have some protective renal effects, which are, however, short lived and clinically insignificant. Because of side effects, misoprostol should be used with caution in these patients.

RCT Entities:   Population Interventions Outcomes