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. ClinicalTrials gov number NCT00346216

中文翻译：

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布洛芬、萘普生和塞来昔布对关节炎患者的血压差异影响：PRECISION-ABPM（塞来昔布综合安全性与布洛芬或萘普生动态血压测量的前瞻性随机评估）试验

非甾体抗炎药 (NSAIDs) 是非选择性和选择性环氧合酶 2 (COX-2) 抑制剂，是世界范围内使用最广泛的处方药之一，但与血压升高 (BP) 和心血管不良反应相关。简历）事件。PRECISION-ABPM 是 PRECISION 的一个子研究，在 60 个地点进行，以确定选择性 COX-2 抑制剂塞来昔布与非选择性 NSAID 萘普生和布洛芬的血压影响。方法和结果 在这项双盲、随机、多中心非劣效性 CV 安全性试验中，444 名患有骨关节炎 (92%) 或类风湿性关节炎 (8%) 的患者（平均年龄 62 ± 10 岁，54% 女性）和或冠心病风险增加的患者接受塞来昔布（100-200 mg 每日两次）、布洛芬（600-800 mg 每日一次）或萘普生（375-500 mg 每日两次）与匹配安慰剂的 1:1：1 分配，以评估 4 个月后对 24 小时动态血压的影响。塞来昔布、布洛芬和萘普生治疗患者的平均 24 小时收缩压 (SBP) 变化为 -0.3 mmHg [95% 置信区间 (CI), -2.25, 1.74], 3.7 (95% CI, 1.72, 5.58)和 1.6 mmHg (95% CI, -0.40, 3.57)。这些变化导致塞来昔布和布洛芬之间的差异为 - 3.9 mmHg (P = 0.0009)，塞来昔布和萘普生之间的差异为 - 1.8 mmHg (P = 0.12)，萘普生和布洛芬之间的差异为 - 2.1 mmHg (P = 0.08)。基线血压正常的患者发生高血压（平均 24 小时 SBP ≥ 130 和/或舒张压 ≥ 80 mmHg）的百分比为布洛芬组为 23.2%，萘普生组为 19.0%，塞来昔布组为 10.3%（优势比 0.39，P = 0.004 和优势比 0.49，分别与布洛芬和萘普生相比，P = 0.03）。结论 PRECISION-ABPM 中，与 COX-2 选择性抑制剂塞来昔布相比，非选择性 NSAID 布洛芬的分配与 SBP 显着增加和新发高血压的发生率较高有关。临床试验政府编号 NCT00346216