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Effect of Cyclooxygenase-2 Inhibition on Renal Function in Elderly Persons Receiving a Low-Salt Diet: A Randomized, Controlled Trial

Suzanne K. Swan, MD; David W. Rudy, MD; Kenneth C. Lasseter, MD; Charles F. Ryan, PhD; Kristin L. Buechel, PA-C; Laurence J. Lambrecht, PharmD; Manuel B. Pinto, BE; Stacy C. Dilzer, RN; Olga Obrda, BS; Kimberly J. Sundblad, BSN; Carol P. Gumbs, BA; David L. Ebel, BS, RPh; Hui Quan, PhD; Patrick J. Larson, MS; Jules I. Schwartz, PharmD, MPH; Thomas A. Musliner, MD; Barry J. Gertz, MD, PhD; D. Craig Brater, MD; and Siu-Long Yao, MD
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Copyright ©2004 by the American College of Physicians

Ann Intern Med. 2000;133(1):1-9. doi:10.7326/0003-4819-133-1-200007040-00002
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Background: Most nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclooxygenase-1 (COX-1), whose inhibition is associated with gastrointestinal ulceration, and COX-2, whose inhibition is associated with therapeutic benefits. Although agents that do not produce COX-1 activity may have fewer adverse effects, targeted disruption of the COX-2 allele in mice has resulted in severe renal problems, suggesting that COX-2 inhibition may also produce adverse effects.

Objective: To determine the effect of rofecoxib, a member of the coxib class of drugs and a specific inhibitor of the COX-2 enzyme, on renal function in elderly patients.

Design: A randomized, three-period, single-dose crossover study and a randomized, parallel-group, multiple-dose study.

Setting: Clinical research units.

Patients: 75 patients 60 to 80 years of age.

Intervention: In the first study, single doses of rofecoxib, 250 mg (about 5-fold to 20-fold the recommended dose); indomethacin, 75 mg; and placebo were administered to 15 patients. In the second study, multiple doses of rofecoxib, 12.5 or 25 mg/d; indomethacin, 50 mg three times daily; or placebo were administered to 60 patients. Patients in both studies received a low-sodium diet.

Measurements: Glomerular filtration rate, creatinine clearance, and urinary and serum sodium and potassium values.

Results: Compared with placebo, single doses of rofecoxib and indomethacin decreased the glomerular filtration rate by 0.23 mL/s (P < 0.001) and 0.18 mL/s (P = 0.003), respectively. In contrast, respective decreases of 0.14, 0.13, and 0.10 mL/s were observed after multiple doses of rofecoxib, 12.5 mg/d (P = 0.019); rofecoxib, 25 mg (P = 0.029), and indomethacin (P = 0.086) were administered. Changes in creatinine clearance and serum and urinary sodium and potassium were less pronounced.

Conclusions: The effects of COX-2 inhibition on renal function are similar to those observed with nonselective NSAIDs. Thus, COX-2 seems to play an important role in human renal function.





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