Shin Sooyoung
Department of clinical Pharmacy, College of Pharmacy, Ajou University, Yeongtong-gu, Suwon, Republic of Korea,
Research institute of Pharmaceutical science and Technology (RIPST), Ajou University, Yeongtong-gu, Suwon, Republic of Korea,
J Pain Res. 2018 Dec 14;11:3211-3219. doi: 10.2147/JPR.S186000. eCollection 2018.
A 2011 systematic review found an increased cardiovascular (CV) risk at both ≤200 mg/day and >200 mg/day doses of celecoxib. This study aimed to evaluate adverse drug events with celecoxib relative to traditional nonsteroidal anti-inflammatory drugs (NSAIDs) in real-world practice settings, focusing on gastrointestinal (GI), CV, and renal toxicity, in older patients with osteoarthritis or rheumatoid arthritis.
In this population-based retrospective cohort study using national health insurance claims data in Korea, patients aged 65 years and older with arthritis who were treated with celecoxib or traditional NSAIDs for ≥30 days in 2016, were included for study analyses. The primary outcome was hospital encounter for GI bleeding associated with celecoxib vs traditional NSAIDs use. The secondary outcomes included a composite of CV diseases, coronary revascularization, and incident renal events.
After 1:1 propensity score matching, 73,748 patients in each cohort were identified for study entry. Celecoxib treatment which lasted for ≥120 days was associated with a lower risk of GI bleeding than traditional NSAIDs (OR=0.84, =0.03). Such a relationship was not observed in shorter treatment strata and overall in all strata combined. When patients with gastroprotective prophylaxis were excluded from subgroup analysis, no evidence of improved GI tolerability was observed with celecoxib. CV and renal risks appeared higher with celecoxib than with traditional NSAIDs (OR=1.08, <0.001 and OR=1.22, <0.001, respectively). About 4.7 % of celecoxib users received a higher than maximum dose (400 mg/day); a dose-dependent increase in CV and renal risks was assessed with celecoxib.
Celecoxib was associated with decreased risk of GI bleeding compared with traditional NSAIDs when treatment lasted for ≥120 days, but such a relationship was not found among subgroup patients with no concomitant use of gastroprotective prophylaxis. Celecoxib users were more likely to experience CV and renal events than traditional NSAIDs users, and a dose-dependent risk relationship was observed with celecoxib.
2011年的一项系统评价发现，塞来昔布剂量≤200毫克/天和>200毫克/天时心血管（CV）风险均增加。本研究旨在评估在现实临床环境中，与传统非甾体抗炎药（NSAIDs）相比，塞来昔布在骨关节炎或类风湿关节炎老年患者中的药物不良事件，重点关注胃肠道（GI）、心血管和肾脏毒性。
在这项基于人群的回顾性队列研究中，使用韩国国家健康保险索赔数据，纳入2016年接受塞来昔布或传统NSAIDs治疗≥30天的65岁及以上关节炎患者进行研究分析。主要结局是与使用塞来昔布和传统NSAIDs相关的胃肠道出血住院情况。次要结局包括心血管疾病、冠状动脉血运重建和新发肾脏事件的复合情况。
经过1:1倾向评分匹配后，每个队列中确定了73748例患者纳入研究。持续≥120天的塞来昔布治疗与胃肠道出血风险低于传统NSAIDs相关（OR = 0.84，P = 0.03）。在较短治疗分层以及所有分层合并分析中均未观察到这种关系。当在亚组分析中排除接受胃保护预防的患者时，未观察到塞来昔布在胃肠道耐受性方面有改善的证据。塞来昔布使用者的心血管和肾脏风险似乎高于传统NSAIDs使用者（OR分别为1.08，P < 0.001和1.22，P < 0.001）。约4.7%的塞来昔布使用者接受的剂量高于最大剂量（400毫克/天）；评估发现塞来昔布存在剂量依赖性的心血管和肾脏风险增加。
与传统NSAIDs相比，当治疗持续≥120天时，塞来昔布与胃肠道出血风险降低相关，但在未同时使用胃保护预防措施的亚组患者中未发现这种关系。塞来昔布使用者比传统NSAIDs使用者更易发生心血管和肾脏事件，且观察到塞来昔布存在剂量依赖性风险关系。
