The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 diabetes mellitus

James R. Sowers, William B. White, Bertram Pitt, Andrew Whelton, Lee S. Simon, Nathaniel Winer, Alan Kivitz, Hein Van Ingen, Thomas Brabant, John G. Fort

Research output: Contribution to journalArticle

Abstract

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors may attenuate the efficacy of antihypertensive agents in high-riskpatients. Therefore, we conducted a double-blind, randomized trial to evaluate the effects of celecoxib, rofecoxib, and naproxen on 24-hour blood pressure (BP) in patients with type 2 diabetes, hypertension, and osteoarthritis. Methods: Patients were randomly assigned to treatment with 200 mg of celecoxib once daily (n= 136), 25 mg of rofecoxib once daily (n=138), or 500 mg of naproxen twice daily (n=130) for 12 weeks. Twenty-four-hour ambulatory BP monitoring and validated arthritis efficacy assessments were conducted at randomization and at weeks 6 and 12 of treatment. The primary end point was the mean change from baseline in average 24-hour systolic BP at week 6. Results: Reductions in osteoarthritis symptoms, including pain, mobility, and stiffness, were similar in all treatment groups. The mean ± SE 24-hour systolic BP following 6 weeks of therapy was increased significantly by rofecoxib (from 130.3 ± 1.2 to 134.5 ± 1.4 mm Hg; P 135 mm Hg) was significandy greater with rofecoxib (30%) than with celecoxib (16%) (P = .05) but not significantly greater than with naproxen (19%). Conclusions: At equally effective doses for osteoarthritis management, treatment with rofecoxib but not celecoxib or naproxen induced a significant increase in 24-hour systolic BP. However, destabilization of hypertension control occurred to some extent in all 3 treatment groups; this phenomenon was seen more often in patients treated with rofecoxib than with the other therapies.

Original languageEnglish (US)
Pages (from-to)161-168
Number of pages8
JournalArchives of Internal Medicine
Volume165
Issue number2
DOIs
StatePublished - Jan 24 2005

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Celecoxib
Cyclooxygenase 2 Inhibitors
Osteoarthritis
Type 2 Diabetes Mellitus
Anti-Inflammatory Agents
Naproxen
Blood Pressure
Hypertension
Therapeutics
Ambulatory Blood Pressure Monitoring
Random Allocation
Antihypertensive Agents
Arthritis
rofecoxib
Pain
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Internal Medicine

Cite this

The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 diabetes mellitus. / Sowers, James R.; White, William B.; Pitt, Bertram; Whelton, Andrew; Simon, Lee S.; Winer, Nathaniel; Kivitz, Alan; Van Ingen, Hein; Brabant, Thomas; Fort, John G.

In: Archives of Internal Medicine, Vol. 165, No. 2, 24.01.2005, p. 161-168.

Research output: Contribution to journalArticle

Sowers, James R. ; White, William B. ; Pitt, Bertram ; Whelton, Andrew ; Simon, Lee S. ; Winer, Nathaniel ; Kivitz, Alan ; Van Ingen, Hein ; Brabant, Thomas ; Fort, John G. / The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 diabetes mellitus. In: Archives of Internal Medicine. 2005 ; Vol. 165, No. 2. pp. 161-168.
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abstract = "Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors may attenuate the efficacy of antihypertensive agents in high-riskpatients. Therefore, we conducted a double-blind, randomized trial to evaluate the effects of celecoxib, rofecoxib, and naproxen on 24-hour blood pressure (BP) in patients with type 2 diabetes, hypertension, and osteoarthritis. Methods: Patients were randomly assigned to treatment with 200 mg of celecoxib once daily (n= 136), 25 mg of rofecoxib once daily (n=138), or 500 mg of naproxen twice daily (n=130) for 12 weeks. Twenty-four-hour ambulatory BP monitoring and validated arthritis efficacy assessments were conducted at randomization and at weeks 6 and 12 of treatment. The primary end point was the mean change from baseline in average 24-hour systolic BP at week 6. Results: Reductions in osteoarthritis symptoms, including pain, mobility, and stiffness, were similar in all treatment groups. The mean ± SE 24-hour systolic BP following 6 weeks of therapy was increased significantly by rofecoxib (from 130.3 ± 1.2 to 134.5 ± 1.4 mm Hg; P 135 mm Hg) was significandy greater with rofecoxib (30{\%}) than with celecoxib (16{\%}) (P = .05) but not significantly greater than with naproxen (19{\%}). Conclusions: At equally effective doses for osteoarthritis management, treatment with rofecoxib but not celecoxib or naproxen induced a significant increase in 24-hour systolic BP. However, destabilization of hypertension control occurred to some extent in all 3 treatment groups; this phenomenon was seen more often in patients treated with rofecoxib than with the other therapies.",
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AU - White, William B.

AU - Pitt, Bertram

AU - Whelton, Andrew

AU - Simon, Lee S.

AU - Winer, Nathaniel

AU - Kivitz, Alan

AU - Van Ingen, Hein

AU - Brabant, Thomas

AU - Fort, John G.

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N2 - Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors may attenuate the efficacy of antihypertensive agents in high-riskpatients. Therefore, we conducted a double-blind, randomized trial to evaluate the effects of celecoxib, rofecoxib, and naproxen on 24-hour blood pressure (BP) in patients with type 2 diabetes, hypertension, and osteoarthritis. Methods: Patients were randomly assigned to treatment with 200 mg of celecoxib once daily (n= 136), 25 mg of rofecoxib once daily (n=138), or 500 mg of naproxen twice daily (n=130) for 12 weeks. Twenty-four-hour ambulatory BP monitoring and validated arthritis efficacy assessments were conducted at randomization and at weeks 6 and 12 of treatment. The primary end point was the mean change from baseline in average 24-hour systolic BP at week 6. Results: Reductions in osteoarthritis symptoms, including pain, mobility, and stiffness, were similar in all treatment groups. The mean ± SE 24-hour systolic BP following 6 weeks of therapy was increased significantly by rofecoxib (from 130.3 ± 1.2 to 134.5 ± 1.4 mm Hg; P 135 mm Hg) was significandy greater with rofecoxib (30%) than with celecoxib (16%) (P = .05) but not significantly greater than with naproxen (19%). Conclusions: At equally effective doses for osteoarthritis management, treatment with rofecoxib but not celecoxib or naproxen induced a significant increase in 24-hour systolic BP. However, destabilization of hypertension control occurred to some extent in all 3 treatment groups; this phenomenon was seen more often in patients treated with rofecoxib than with the other therapies.

AB - Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors may attenuate the efficacy of antihypertensive agents in high-riskpatients. Therefore, we conducted a double-blind, randomized trial to evaluate the effects of celecoxib, rofecoxib, and naproxen on 24-hour blood pressure (BP) in patients with type 2 diabetes, hypertension, and osteoarthritis. Methods: Patients were randomly assigned to treatment with 200 mg of celecoxib once daily (n= 136), 25 mg of rofecoxib once daily (n=138), or 500 mg of naproxen twice daily (n=130) for 12 weeks. Twenty-four-hour ambulatory BP monitoring and validated arthritis efficacy assessments were conducted at randomization and at weeks 6 and 12 of treatment. The primary end point was the mean change from baseline in average 24-hour systolic BP at week 6. Results: Reductions in osteoarthritis symptoms, including pain, mobility, and stiffness, were similar in all treatment groups. The mean ± SE 24-hour systolic BP following 6 weeks of therapy was increased significantly by rofecoxib (from 130.3 ± 1.2 to 134.5 ± 1.4 mm Hg; P 135 mm Hg) was significandy greater with rofecoxib (30%) than with celecoxib (16%) (P = .05) but not significantly greater than with naproxen (19%). Conclusions: At equally effective doses for osteoarthritis management, treatment with rofecoxib but not celecoxib or naproxen induced a significant increase in 24-hour systolic BP. However, destabilization of hypertension control occurred to some extent in all 3 treatment groups; this phenomenon was seen more often in patients treated with rofecoxib than with the other therapies.

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