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Effects of Etoricoxib and Comparator Nonsteroidal Anti-Inflammatory Drugs on Urinary Sodium Excretion, Blood Pressure, and Other Renal Function Indicators in Elderly Subjects Consuming a Controlled Sodium Diet

From Merck Research Laboratories, Rahway, New Jersey (Dr Schwartz, Dr Thach, Ms Miller, Mr Hreniuk, Ms Hilliard, Ms Snyder, Dr Gertz, Dr Gottesdiener) and Clinical Pharmacology Associates, Miami, Florida (Dr Lasseter).

This multicenter, double-blind, randomized, placebo-controlled, parallel-group study assessed renal function during dosing with etoricoxib 90 mg daily, celecoxib 200 mg twice daily, and naproxen 500 mg twice daily. Male and female subjects 60 to 81 years old (n = 85), in sodium balance on a controlled, normal sodium diet, were treated for 15 days. There were no clinically meaningful between-treatment differences in urinary sodium excretion, creatinine clearance, body weight, or serum electrolytes during the 2 weeks of treatment. Etoricoxib and celecoxib had no effect on the urinary thromboxane metabolite, 11-dehydrothromboxane B₂, while significantly decreasing the urinary prostacyclin metabolite, 2,3-dinor-6-keto PGF₁. Decreases were greater for both metabolites following naproxen. Ambulatory systolic blood pressures were significantly higher than placebo for all treatments, with moderately greater increases for etoricoxib relative to other active treatments on day 14. Ambulatory diastolic blood pressures were significantly higher than placebo for etoricoxib and naproxen but not for celecoxib.

Key Words: Etoricoxib • celecoxib • naproxen • sodium excretion • blood pressure

Address for correspondence: Dr Jules I. Schwartz, Merck Research Laboratories, 126 E. Lincoln Avenue, PO Box 2000, RY34-A552, Rahway, NJ 07065-0900; e-mail: jules_schwartz{at}merck.com.

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