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SAT0055 Effect of rofecoxib, celecoxib, and naproxen on blood pressure and urinary sodium excretion in elderly volunteers
  1. JI Schwartz1,
  2. MP Malice2,
  3. KC Lasseter3,
  4. GB Holmes4,
  5. KM Gottesdiener1,
  6. K Brune5
  1. 1Clinical Pharmacology, Merck & Co, Inc., Rahway
  2. 2Biostatistics, Merck & Co, Inc., Brussels, Belgium
  3. 3Clinical Research, Clinical Pharmacology Associates, Miami
  4. 4Clinical Research, SFBC-International, Miami, USA
  5. 5Clinical Pharmacology, University Erlangen, Erlangen, Germany


Background Nonsteroidal anti-inflammatory drugs (NSAIDs) can affect sodium reabsorption by decreasing the synthesis of renal prostaglandins. Since COX-2 is constitutively expressed in the kidney, it is hypothesised that the effects of COX-2 inhibitors on sodium handling would be similar to non-selective NSAIDs. It is hypothesised moreover that the effects of the two COX-2 inhibitors on sodium handling would be similar.

Objectives This study evaluated the effects of two COX-2 inhibitors [rofecoxib, 25 mg QD and celecoxib, 200 mg BID], a nonselective NSAID [naproxen, 500 mg BID], and placebo on blood pressure (BP) and urinary sodium excretion during a 2-week in-house administration.

Methods 67 healthy elderly (60 to 80 years) subjects participated in a double-blind, placebo-controlled, parallel-group study. Subjects received a weight-maintaining isocaloric diet (200 mEq sodium, 0.8 g/kg protein, 80 to 120 mEq potassium daily), beginning 8–13 days prior to the first dose of study drug. After attaining sodium balance [based on stable weight (within 0.5 kg) and 24-hour urinary sodium between 180 to 220 mEq on 2 consecutive days], subjects were randomised to treatment. Daily 24-hour urine collections were obtained. Daily BP measurements were taken at 8AM and 8PM, and more often (8 AM, Noon, 4 PM, and 8 PM) on Days -1, 1, 7, and 14.

Results Least-Squares mean changes from baseline (SE) for average daily BP on Day 14 (prespecified primary endpoint for BP) are shown in the Table 1 below. There was no significant difference between the active treatment groups in daily average sodium excretion during the first 3 days or over 2 weeks of treatment (p > 0.05). No incidence of peripheral oedema occurred during the 2 week treatment. Two subjects experienced elevated systolic BP during the course of the trial (one on each COX-2 inhibitor).

Abstract SAT0055 Table 1

Conclusion These results, obtained under well-controlled conditions for two weeks, suggest that the COX-2 selective agents, rofecoxib and celecoxib, have similar effects on BP and urinary sodium excretion; their effect is similar also to that of non-selective NSAIDs.

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