Evaluation of the renal protective effect of misoprostol in elderly, osteoarthritic patients at risk for nonsteroidal anti-inflammatory drug-induced renal dysfunction.
An age greater than 60 and diuretic use have been implicated as risk factors for nonsteroidal anti-inflammatory drug (NSAID)-induced decreases in renal function. Misoprostol, a prostaglandin E1 analog, was studied in nine elderly osteoarthritic patients at risk for NSAID-induced renal dysfunction to determine whether it could prevent NSAID-induced renal dysfunction. Subjects received ibuprofen 2400 mg/day and either misoprostol 800 mcg/day or placebo for 14 days in a randomized, double-blinded, crossover trial. Glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) studies using inulin and PAH plasma clearance, urinary prostaglandin E2 (PGE2) and protein excretion, and serum electrolytes were obtained at baseline, after the first dose, and on day 7 and 14 of each treatment period. Prostaglandin E2 excretion was significantly reduced after the first dose of ibuprofen and throughout the 14 days in both the misoprostol and placebo treatment groups. No statistically significant differences in GFR, ERPF, protein excretion, serum potassium, or serum sodium were detected between misoprostol and placebo treatment during the 14 days of ibuprofen treatment. However, a subset of two patients who exhibited a decrease of greater than 20% in GFR during placebo treatment, appeared to demonstrate an attenuation of this decline when treated with misoprostol. Effect of time, independent of treatment group, indicated that ERPF was significantly decreased from baseline after the first dose of ibuprofen (P < or = 0.05), whereas GFR was notably diminished from baseline on day 14 only (P < or = 0.05). Misoprostol does not influence GFR and ERPF in unselected subjects purportedly at risk for NSAID-induced renal dysfunction.(ABSTRACT TRUNCATED AT 250 WORDS)
Fullerton
T
T
Center for Clinical Pharmacy Research, State University of New York at Buffalo.
Sica
D A
DA
Blum
R A
RA
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D015232:Dinoprostone / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects; D007674:Kidney Diseases / Q000139:chemically induced / Q000150:complications / Q000517:prevention & control*; D007677:Kidney Function Tests; D016595:Misoprostol / Q000627:therapeutic use*; D010003:Osteoarthritis / Q000150:complications* / Q000188:drug therapy; D012079:Renal Circulation / Q000187:drug effects; D012307:Risk Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016595:Misoprostol; D015232:Dinoprostone; D007052:Ibuprofen