Comparison of rofecoxib, celecoxib, and naproxen on renal function in elderly subjects receiving a normal-salt diet
| Autor: | Kay Brune, R. N. Kalyani, K. Vandormael, Barry J. Gertz, G. B. Holmes, Keith Gottesdiener, M. P. Malice, K.-J. Redfern, M. Laurenzi, K. C. Lasseter, Jules I. Schwartz |
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| Rok vydání: | 2002 |
| Předmět: |
Male
medicine.medical_specialty Naproxen Analgesic Urology Renal function Blood Pressure Placebo Kidney Electrolytes Lactones Double-Blind Method Internal medicine medicine Humans Pharmacology (medical) Cyclooxygenase Inhibitors Sulfones Sodium Chloride Dietary Rofecoxib Aged Pharmacology Aged 80 and over Sulfonamides biology business.industry Weight change Body Weight Sodium Middle Aged Diet Endocrinology Celecoxib Creatinine biology.protein Potassium Pyrazoles Female Cyclooxygenase business medicine.drug |
| Zdroj: | Clinical pharmacology and therapeutics. 72(1) |
| ISSN: | 0009-9236 |
| Popis: | Background This study compared directly the renal effects of two selective cyclooxygenase (COX)-2 inhibitors (rofecoxib and celecoxib) with naproxen (dual COX-1/COX-2 inhibitor) and placebo in healthy elderly subjects on a sodium-replete diet. Methods A total of 67 elderly subjects stabilized in the clinic for weight andurinary sodium on a controlled 200-mEq sodium diet were randomized in a double-blind fashion to receive rofecoxib, 25 mg daily (n = 17); celecoxib, 200 mg twice daily (n = 17); naproxen, 500 mg twice daily (n = 17); or matching placebo (n = 16) for 28 days. Subjects were sequestered in the clinic for the first 14 treatment days on the controlled diet. Results Daily urinary sodium excretion during the first 72 hours of treatment (primary endpoint) significantly decreased in rofecoxib, celecoxib, and naproxen groups compared with baseline (P ≤ .05). Rofecoxib and celecoxib decreases in urinarysodium excretion rates that were comparable with each other, on the basis of predefined boundaries (−39.5 versus −27.1 mEq/d, respectively) and to naproxen (−40.6, mEq/d). Rofecoxib, celecoxib, and naproxen increased mean systolic blood pressure to a similar degree (3.4, 4.3, and 3.1 mm Hg, respectively, versus −1.3 mm Hg for placebo) after 14 days of treatment; small changes also occurred in diastolic blood pressure (0.3, 0.8, and −0.4 mm Hg, respectively, versus −1.4 mm Hg for placebo). Changes from baseline in creatinine clearance, body weight, and urinary potassium excretion among active treatments were similar. After 28 days of treatment, findings were generally consistent with those at 14 days. No subject reported edema or discontinued treatment as the result of an adverse experience. Conclusion In healthy elderly subjects on a sodium-replete diet, the COX-2 inhibitors rofecoxib and celecoxib did not differ from a nonselective nonsteroidal anti-inflammatory drug (naproxen), in influencing renal function as measured by urinary sodium excretion, systolic and diastolic blood pressure, creatinine clearance, or weight change. Clinical Pharmacology & Therapeutics (2002) 72, 50–61; doi: 10.1067/mcp.2002.126182 |
| Databáze: | OpenAIRE |
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