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William B. White, Andrew Whelton, Alfonso E. Bello, John G. Fort, P-447: Blood pressure control and edema rates in older patients with systolic hypertension and osteoarthritis following treatment with COX-2 specific inhibitors, American Journal of Hypertension, Volume 14, Issue S1, April 2001, Page 181A, https://doi.org/10.1016/S0895-7061(01)01619-3
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Studies during the past 15 years have shown that nonsteroidal anti-inflammatory agents (NSAIDs) may interfere with the efficacy of antihypertensive drug therapy. Less is known about celecoxib and rofecoxib, the new cyclooxygenase-2 (COX-2) specific inhibitors. To assess the impact of the COX-2 inhibitors on systolic blood pressure (SBP) control and the development of edema in older (≥ 65 years) treated hypertensive patients with osteoarthritis, we evaluated celecoxib and rofecoxib in a randomized, double-blind, prospective, parallel group clinical trial. Methods: 810 patients with hypertension received either celecoxib 200 mg QD (n=411) or rofecoxib 25 mg QD (n=399) for 6 weeks. Changes from baseline in mean SBP and body weight were determined in the overall patient population and in those patients who developed lower extremity edema. Edema was defined as any change from baseline occurring on a 5-point scale of 0 to ++++. Results: Changes in SBP and body weight are shown below for the entire study group and for those who developed edema:
Mean changes from baseline in SBP were lower in patients on celecoxib than in rofecoxib-treated patients in all groups. Among patients in whom edema developed, the mean changes from baseline in SBP were higher than that observed in the overall population. These data suggest that there may be a relationship between the development of edema and a loss of BP control among patients with hypertension receiving COX-2 specific inhibitors. Grant/Research Support - Pharmacia, AstraZeneca, BMS Consultant - Pharmacia, TEVA, Boehringer Ingelheim, Speakers' Bureau - most major pharmaceutical companies. (See Table)
| . | Week 1 . | Week 2 . | Week 6 . | |||
|---|---|---|---|---|---|---|
| . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . |
| Change in SBP (mm Hg) | ||||||
| All pts. | -0.3±0.6a | 2.1 ± 0.6 | -0.2 ±0.6b | 2.6 ± 0.7 | -0.5 ± 0.7b | 2.6 ± 0.8 |
| w/ edema | 1.6 ± 1.3 | 4.6 ± 1.1 | 2.7 ± 1.5 | 5.8 ± 1.5 | -1.1 ± 1.6b | 5.9 ± 1.5 |
| Change in weight (%) | ||||||
| All pts | 0.1 ±0.1b | 0.6 ± 0.1 | 0.2 ±0.1b | 0.7 ± 0.1 | 0.2 ± 0.1b | 0.6 ± 0.1 |
| w/ edema | 0.4 ±0.1c | 0.8 ± 0.2 | 0.5 ±0.1b | 1.1 ± 0.2 | 0.8 ± 0.2d | 1.2 ± 0.2 |
| . | Week 1 . | Week 2 . | Week 6 . | |||
|---|---|---|---|---|---|---|
| . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . |
| Change in SBP (mm Hg) | ||||||
| All pts. | -0.3±0.6a | 2.1 ± 0.6 | -0.2 ±0.6b | 2.6 ± 0.7 | -0.5 ± 0.7b | 2.6 ± 0.8 |
| w/ edema | 1.6 ± 1.3 | 4.6 ± 1.1 | 2.7 ± 1.5 | 5.8 ± 1.5 | -1.1 ± 1.6b | 5.9 ± 1.5 |
| Change in weight (%) | ||||||
| All pts | 0.1 ±0.1b | 0.6 ± 0.1 | 0.2 ±0.1b | 0.7 ± 0.1 | 0.2 ± 0.1b | 0.6 ± 0.1 |
| w/ edema | 0.4 ±0.1c | 0.8 ± 0.2 | 0.5 ±0.1b | 1.1 ± 0.2 | 0.8 ± 0.2d | 1.2 ± 0.2 |
P=0.014;
P<0.01;
P=0.047;
P=0.061 for celecoxib vs rofecoxib.
| . | Week 1 . | Week 2 . | Week 6 . | |||
|---|---|---|---|---|---|---|
| . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . |
| Change in SBP (mm Hg) | ||||||
| All pts. | -0.3±0.6a | 2.1 ± 0.6 | -0.2 ±0.6b | 2.6 ± 0.7 | -0.5 ± 0.7b | 2.6 ± 0.8 |
| w/ edema | 1.6 ± 1.3 | 4.6 ± 1.1 | 2.7 ± 1.5 | 5.8 ± 1.5 | -1.1 ± 1.6b | 5.9 ± 1.5 |
| Change in weight (%) | ||||||
| All pts | 0.1 ±0.1b | 0.6 ± 0.1 | 0.2 ±0.1b | 0.7 ± 0.1 | 0.2 ± 0.1b | 0.6 ± 0.1 |
| w/ edema | 0.4 ±0.1c | 0.8 ± 0.2 | 0.5 ±0.1b | 1.1 ± 0.2 | 0.8 ± 0.2d | 1.2 ± 0.2 |
| . | Week 1 . | Week 2 . | Week 6 . | |||
|---|---|---|---|---|---|---|
| . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . | Celecoxib . | Rofecoxib . |
| Change in SBP (mm Hg) | ||||||
| All pts. | -0.3±0.6a | 2.1 ± 0.6 | -0.2 ±0.6b | 2.6 ± 0.7 | -0.5 ± 0.7b | 2.6 ± 0.8 |
| w/ edema | 1.6 ± 1.3 | 4.6 ± 1.1 | 2.7 ± 1.5 | 5.8 ± 1.5 | -1.1 ± 1.6b | 5.9 ± 1.5 |
| Change in weight (%) | ||||||
| All pts | 0.1 ±0.1b | 0.6 ± 0.1 | 0.2 ±0.1b | 0.7 ± 0.1 | 0.2 ± 0.1b | 0.6 ± 0.1 |
| w/ edema | 0.4 ±0.1c | 0.8 ± 0.2 | 0.5 ±0.1b | 1.1 ± 0.2 | 0.8 ± 0.2d | 1.2 ± 0.2 |
P=0.014;
P<0.01;
P=0.047;
P=0.061 for celecoxib vs rofecoxib.
- antihypertensive agents
- hypertension
- systolic hypertension
- cyclooxygenase-2
- edema
- systolic blood pressure
- anti-inflammatory agents, non-steroidal
- brachial plexus neuritis
- consultants
- osteoarthritis
- celecoxib
- rofecoxib
- cyclooxygenase-2 inhibitors
- older adult
- lower extremity edema
- blood pressure regulation
- pharmaceutical company
