Concomitant use of nonsteroidal anti-inflammatory drugs (
NSAIDs), including the
cyclooxygenase-2 (COX-2) specific inhibitors, with
antihypertensive medication is common practice for many patients with
arthritis. This study evaluated the effects of
celecoxib 200 mg/day and
rofecoxib 25 mg/day on blood pressure (BP) and
edema in a 6-week, randomized, parallel-group, double-blind study in patients > or =65 years of age with
osteoarthritis who were treated with fixed
antihypertensive regimens. One thousand ninety-two patients received study medication (
celecoxib, n = 549;
rofecoxib, n = 543). Significantly more patients in the
rofecoxib group compared with the
celecoxib group developed increased systolic BP (change >20 mm Hg plus absolute value > or =140 mm Hg) at any time point (14.9% vs 6.9%, p <0.01).
Rofecoxib caused the greatest increase in systolic BP in patients receiving
angiotensin-converting enzyme inhibitors or beta blockers, whereas those on
calcium channel antagonists or
diuretic monotherapy receiving either
celecoxib or
rofecoxib showed no significant increases in BP. Clinically significant new-onset or worsening
edema associated with
weight gain developed in a greater percentage of patients in the
rofecoxib group (7.7%) compared with the
celecoxib group (4.7%) (p <0.05). Thus, in patients with controlled
hypertension on a fixed
antihypertensive regimen, careful monitoring of BP is warranted after the initiation of
celecoxib or
rofecoxib therapy.