Medical Affairs, Pfizer Inc., New York, NY 10017, USA.
Curr Med Res Opin. 2011 Jul;27(7):1359-66. doi: 10.1185/03007995.2011.581274. Epub 2011 May 12.
Gastrointestinal (GI) tolerability is an important treatment consideration for physicians when choosing a nonselective nonsteroidal anti-inflammatory drug (NSAID) for their elderly arthritis patients. The objective of this study was to compare the GI tolerability of the cyclooxygenase-2 selective NSAID celecoxib and nonselective NSAIDs in elderly patients with arthritis aged 65 years or older.
This was a retrospective, pooled analysis of patients aged 65 years or older with osteoarthritis (OA), rheumatoid arthritis (RA), or ankylosing spondylitis (AS) from randomized, parallel-group trials. Selected trials had a duration of ≥2 weeks and at least one celecoxib 200-400 mg/day and one nonselective NSAID (naproxen, ibuprofen, or diclofenac) arm. Patient-level data from the safety populations of the trials were pooled. Analysis included the combined incidence of the GI intolerability adverse events (AEs) (abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea) and incidence and time to trial discontinuation due to these intolerability AEs.
A total of 21 trials were selected involving 9461 elderly patients (mean age 71.9 years). Of these, 5872 received celecoxib, 1104 naproxen, 151 ibuprofen, and 2334 diclofenac. The combined incidence of GI intolerability AEs were reported by significantly fewer patients treated with celecoxib (16.7%) than naproxen (29.4%; p < 0.0001), ibuprofen (26.5%; p = 0.0016), or diclofenac (21.0%; p < 0.0001). The discontinuation rate due to GI intolerability AEs was significantly lower for celecoxib (4.0%) versus naproxen (8.1%; p < 0.0001) and ibuprofen (7.3%; p < 0.05), but not diclofenac (4.2%; p = 0.75).
Among elderly arthritis patients, the incidence of GI intolerability AEs was lower with celecoxib than with naproxen, ibuprofen, or diclofenac. Fewer elderly patients discontinued due to GI intolerability AEs with celecoxib than with either naproxen or ibuprofen.
胃肠道（GI）耐受性是医生在为老年关节炎患者选择非选择性非甾体抗炎药（NSAID）时的一个重要考虑因素。本研究的目的是比较 COX-2 选择性 NSAID 塞来昔布和非选择性 NSAID 在 65 岁或以上老年关节炎患者中的 GI 耐受性。
这是一项对来自随机、平行组试验的 65 岁或以上骨关节炎（OA）、类风湿关节炎（RA）或强直性脊柱炎（AS）患者的回顾性、汇总分析。入选试验的持续时间≥2 周，至少有塞来昔布 200-400mg/天和一种非选择性 NSAID（萘普生、布洛芬或双氯芬酸）组。汇总了试验安全性人群的患者水平数据。分析包括 GI 不耐受不良事件（AE）（腹痛、便秘、腹泻、消化不良、气胀、恶心）的综合发生率以及因这些不耐受 AE 而终止试验的发生率和时间。
共纳入 21 项涉及 9461 例老年患者（平均年龄 71.9 岁）的试验。其中 5872 例接受塞来昔布治疗，1104 例接受萘普生治疗，151 例接受布洛芬治疗，2334 例接受双氯芬酸治疗。接受塞来昔布治疗的患者 GI 不耐受 AE 的综合发生率明显低于萘普生（29.4%；p<0.0001）、布洛芬（26.5%；p=0.0016）或双氯芬酸（21.0%；p<0.0001）。因 GI 不耐受 AE 而停药的发生率塞来昔布明显低于萘普生（8.1%；p<0.0001）和布洛芬（7.3%；p<0.05），但与双氯芬酸（4.2%；p=0.75）无差异。
在老年关节炎患者中，塞来昔布的 GI 不耐受 AE 发生率低于萘普生、布洛芬或双氯芬酸。与萘普生或布洛芬相比，因 GI 不耐受 AE 而停药的老年患者更少。
