TY - JOUR
T1 - Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement (Trial)
AU - Ruschitzka, Frank
AU - Borer, Jeffrey S.
AU - Krum, Henry
AU - Flammer, Andreas J.
AU - Yeomans, Neville D.
AU - Libby, Peter
AU - Luscher, Thomas F.
AU - Solomon, Daniel H.
AU - Husni, M. Elaine
AU - Graham, David Y.
AU - Davey, Deborah A.
AU - Wisniewski, Lisa M.
AU - Menon, Venu
AU - Fayyad, Rana
AU - Beckerman, Bruce
AU - Iorga, Dinu
AU - Lincoff, A. Michael
AU - Nissen, Steven E.
PY - 2017
Y1 - 2017
N2 - Aims. Non-steroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but associate with increased blood pressure (BP) and adverse cardiovascular (CV) events. PRECISION-ABPM, a substudy of PRECISION was conducted at 60 sites, to determine BP effects of the selective COX-2 inhibitor celecoxib vs. the non-selective NSAIDs naproxen and ibuprofen. Methods and results. In this double-blind, randomized, multicentre non-inferiority CV-safety trial, 444 patients (mean age 62 +/- 10 years, 54% female) with osteoarthritis (92%) or rheumatoid arthritis (8%) and evidence of or at increased risk for coronary artery disease received celecoxib (100-200 mg bid), ibuprofen (600-800 mg tid), or naproxen (375-500 mg bid) with matching placebos in a 1: 1: 1 allocation, to assess the effect on 24-h ambulatory BP after 4 months. The change in mean 24-h systolic BP (SBP) in celecoxib, ibuprofen and naproxen-treated patients was -0.3 mmHg [95% confidence interval (CI), -2.25, 1.74], 3.7 (95% CI, 1.72, 5.58) and 1.6 mmHg (95% CI, -0.40, 3.57), respectively. These changes resulted in a difference of -3.9 mmHg (P = 0.0009) between celecoxib and ibuprofen, of -1.8 mmHg (P = 0.12) between celecoxib and naproxen, and of -2.1 mmHg (P = 0.08) between naproxen and ibuprofen. The percentage of patients with normal baseline BP who developed hypertension (mean 24-h SBP >= 130 and/or diastolic BP >= 80 mmHg) was 23.2% for ibuprofen, 19.0% for naproxen, and 10.3% for celecoxib (odds ratio 0.39, P = 0.004 and odds ratio 0.49, P = 0.03 vs. ibuprofen and naproxen, respectively). Conclusions. In PRECISION-ABPM, allocation to the non-selective NSAID ibuprofen, compared with the COX-2 selective inhibitor celecoxib was associated with a significant increase of SBP, and a higher incidence of new-onset hypertension.
AB - Aims. Non-steroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but associate with increased blood pressure (BP) and adverse cardiovascular (CV) events. PRECISION-ABPM, a substudy of PRECISION was conducted at 60 sites, to determine BP effects of the selective COX-2 inhibitor celecoxib vs. the non-selective NSAIDs naproxen and ibuprofen. Methods and results. In this double-blind, randomized, multicentre non-inferiority CV-safety trial, 444 patients (mean age 62 +/- 10 years, 54% female) with osteoarthritis (92%) or rheumatoid arthritis (8%) and evidence of or at increased risk for coronary artery disease received celecoxib (100-200 mg bid), ibuprofen (600-800 mg tid), or naproxen (375-500 mg bid) with matching placebos in a 1: 1: 1 allocation, to assess the effect on 24-h ambulatory BP after 4 months. The change in mean 24-h systolic BP (SBP) in celecoxib, ibuprofen and naproxen-treated patients was -0.3 mmHg [95% confidence interval (CI), -2.25, 1.74], 3.7 (95% CI, 1.72, 5.58) and 1.6 mmHg (95% CI, -0.40, 3.57), respectively. These changes resulted in a difference of -3.9 mmHg (P = 0.0009) between celecoxib and ibuprofen, of -1.8 mmHg (P = 0.12) between celecoxib and naproxen, and of -2.1 mmHg (P = 0.08) between naproxen and ibuprofen. The percentage of patients with normal baseline BP who developed hypertension (mean 24-h SBP >= 130 and/or diastolic BP >= 80 mmHg) was 23.2% for ibuprofen, 19.0% for naproxen, and 10.3% for celecoxib (odds ratio 0.39, P = 0.004 and odds ratio 0.49, P = 0.03 vs. ibuprofen and naproxen, respectively). Conclusions. In PRECISION-ABPM, allocation to the non-selective NSAID ibuprofen, compared with the COX-2 selective inhibitor celecoxib was associated with a significant increase of SBP, and a higher incidence of new-onset hypertension.
KW - cardiovascular system
KW - cyclooxygenase 2
KW - hypertension
KW - inhibitors
KW - nonsteroidal anti, inflammatory agents
KW - osteoarthritis
UR - http://handle.westernsydney.edu.au:8081/1959.7/uws:45062
U2 - 10.1093/eurheartj/ehx508
DO - 10.1093/eurheartj/ehx508
M3 - Article
SN - 1522-9645
SN - 0195-668X
VL - 38
SP - 3282
EP - 3292
JO - European Heart Journal
JF - European Heart Journal
IS - 44
ER -