Division of Rheumatology, Center for Inflammatory Joint Diseases, Munich, Germany.
Curr Med Res Opin. 2012 Sep;28(9):1537-45. doi: 10.1185/03007995.2012.717528. Epub 2012 Aug 16.
To compare the safety and efficacy of celecoxib versus diclofenac slow release (SR) plus omeprazole in elderly arthritis patients.
Patients aged≥65 years, with osteoarthritis and/or rheumatoid arthritis, at high gastrointestinal (GI) risk who participated in the CONDOR trial (Celecoxib vs. Omeprazole and Diclofenac in Patients With Osteoarthritis and Rheumatoid Arthritis) were included in this subanalysis. CONDOR was a 6-month prospective, double-blind, randomized, parallel-group, multicenter, international study comparing treatment with celecoxib 200 mg twice daily (BID) versus diclofenac SR 75 mg BID plus omeprazole 20 mg daily.
The primary end point was a composite of Clinically Significant Upper and Lower GI Events adjudicated by an independent blinded expert committee. Efficacy was determined by the Patient's Global Assessment of Arthritis.
A total of 2446 patients aged≥65 years were included in the intent-to-treat (ITT) population (n=1219 celecoxib; n=1227 diclofenac). Eight patients in the celecoxib group and 52 in the diclofenac group were adjudicated as having Clinically Significant Upper and Lower GI events (adjusted odds ratio: 6.27; p<0.0001). Clinically significant reductions in hemoglobin (≥2 g/dL) and/or hematocrit (≥10%) were observed in 23 patients in the celecoxib group and in 76 in the diclofenac group (relative risk: 3.22 [95% confidence interval: 2.04-5.07]; p<0.0001). Incidence of moderate-to-severe abdominal symptoms and discontinuation of treatment due to GI adverse events (AEs) were lower in the celecoxib group. The Patient's Global Assessment of Arthritis score least squares mean change from baseline to final visit and percentage of patients rating treatment efficacy as good/very good at baseline and final visit were similar in both groups.
The dose of celecoxib used is consistent with the European label for the management of osteoarthritis and may not reflect what is commonly prescribed in current clinical practice in the United States. The data were obtained in a clinical trial setting where patients were enrolled based on specific inclusion and exclusion criteria; as such, the patients may not be broadly representative of the patient population in a general practice setting.
Efficacy was comparable in the two treatment groups. There were fewer endpoints as well as fewer GI AEs reported in patients treated with celecoxib compared with diclofenac. These data may help physicians in their treatment decisions for elderly patients with arthritis.
比较塞来昔布与双氯芬酸缓释片（SR）加奥美拉唑在老年关节炎患者中的安全性和疗效。
本亚分析纳入了 CONDOR 试验（塞来昔布与奥美拉唑和双氯芬酸治疗骨关节炎和类风湿关节炎患者）中年龄≥65 岁、有胃肠道（GI）高风险的骨关节炎和/或类风湿关节炎患者。CONDOR 是一项为期 6 个月的前瞻性、双盲、随机、平行分组、多中心、国际研究，比较了塞来昔布 200mg 每日两次（BID）与双氯芬酸 SR 75mg BID 加奥美拉唑 20mg 每日的治疗效果。
主要终点是由独立盲法专家委员会判定的上消化道和下消化道临床显著事件的复合终点。通过患者的关节炎总体评估来确定疗效。
共有 2446 名年龄≥65 岁的患者纳入意向治疗（ITT）人群（塞来昔布组 n=1219；双氯芬酸组 n=1227）。塞来昔布组有 8 例患者和双氯芬酸组有 52 例患者被判定为上消化道和下消化道临床显著事件（校正优势比：6.27；p<0.0001）。塞来昔布组有 23 例患者出现血红蛋白（≥2g/dL）和/或红细胞压积（≥10%）的临床显著下降，双氯芬酸组有 76 例患者出现这种情况（相对风险：3.22[95%置信区间：2.04-5.07]；p<0.0001）。塞来昔布组的中度至重度腹部症状发生率和因 GI 不良反应（AE）而停药的比例较低。两组患者的关节炎总体评估评分自基线至末次随访的最小二乘均数变化以及基线和末次随访时患者对治疗效果的评价为良好/非常好的比例均相似。
使用的塞来昔布剂量与欧洲治疗骨关节炎的标签一致，可能与美国目前临床实践中的常用剂量不一致。数据来自临床试验环境，患者是根据特定的纳入和排除标准入组的；因此，患者可能不能广泛代表一般实践环境中的患者群体。
两组治疗的疗效相当。与双氯芬酸相比，接受塞来昔布治疗的患者报告的终点事件和胃肠道不良事件更少。这些数据可能有助于医生为老年关节炎患者做出治疗决策。
