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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, MD;
William B. White, MD;
Bertram Pitt, MD;
Andrew Whelton, MD;
Lee S. Simon, MD;
Nathaniel Winer, MD;
Alan Kivitz, MD;
Hein van Ingen, MD;
Thomas Brabant, MD;
John G. Fort, MD; for the Celecoxib Rofecoxib Efficacy and Safety in Comorbidities Evaluation Trial (CRESCENT) Investigators
Arch Intern Med. 2005;165:161-168.
Background Nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors may attenuate the efficacy of antihypertensive agents in high-risk patients. 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<.001) but not by celecoxib (132.0 ± 1.3 to 131.9 ± 1.3 mm Hg; P = .54) or naproxen (133.7 ± 1.5 to 133.0 ± 1.4 mm Hg; P = .74). The BP difference between rofecoxib and celecoxib was 3.78 mm Hg (95% confidence interval, 1.18-6.38; P = .005); between rofecoxib and naproxen, 3.85 mm Hg (95% confidence interval, 1.15-6.55; P = .005). The proportion of patients with controlled hypertension at baseline who developed ambulatory hypertension by week 6 (24-hour systolic BP>135 mm Hg) was significantly 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.
Author Affiliations: State University of New York, Brooklyn (Drs Sowers and Winer); University of Connecticut School of Medicine, Farmington (Dr White); University of Michigan School of Medicine, Ann Arbor (Dr Pitt); Universal Clinical Research Center and The Johns Hopkins University School of Medicine, Baltimore, Md (Dr Whelton); Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (Dr Simon); Altoona Center for Clinical Research, Duncansville, Pa (Dr Kivitz); Pfizer Inc, Peapack, NJ (Drs van Ingen and Fort); and Krankenhaus St Joseph-Stift, Bremen, Germany (Dr Brabant). Dr Sowers is now at the University of Missouri School of Medicine, Columbia.
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