Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or =65 years of age with systemic hypertension and osteoarthritis.
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.
Whelton
Andrew
A
Universal Clinical Research Center, Inc., and The Johns Hopkins University School of Medicine, Baltimore, Maryland 21030-1603, USA. huntvalley@col.com
White
William B
WB
Bello
Alfonso E
AE
Puma
Joseph A
JA
Fort
John G
JG
D000367:Age Factors; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use; D004311:Double-Blind Method; D004341:Drug Evaluation; D004487:Edema / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy*; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D009656:North America; D010003:Osteoarthritis / Q000150:complications* / Q000188:drug therapy*; D011720:Pyrazoles; D013449:Sulfonamides / Q000627:therapeutic use*; D013450:Sulfones; D013599:Systole / Q000187:drug effects; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000959:Antihypertensive Agents; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D000068579:Celecoxib