CIBERehd. IIS Aragón, Universidad de Zaragoza, Zaragoza, Spain.
Aliment Pharmacol Ther. 2012 Sep;36(5):485-92. doi: 10.1111/j.1365-2036.2012.05213.x. Epub 2012 Jul 15.
Nonsteroidal anti-inflammatory drugs are associated with gastrointestinal (GI) damage. The Celecoxib vs. Omeprazole and Diclofenac for At-Risk Osteoarthritis and Rheumatoid Arthritis Patients (CONDOR) trial showed that a haemoglobin drop ≥2 g/dL adjudicated as either of defined or presumed GI origin was the most frequent component/event for the composite GI primary end point. This adverse event is potentially clinically relevant in long-term NSAID treatment.
To define potential risk factors associated with a decrease in haemoglobin/haematocrit.
Post hoc analysis of the CONDOR trial was conducted in the intention-to-treat population. Clinically significant blood loss was defined as: (i) a haemoglobin drop ≥2 g/dL and/or a haematocrit drop ≥10%; and (ii) blood loss adjudicated as either of defined or presumed GI origin. Fifteen risk factors were evaluated by stepwise logistic regression. Each factor had to be significant at <0.20 α to be included in the model.
A total of 64/3774 (1.7%) osteoarthritis (OA) patients had decreased haemoglobin/haematocrit and were adjudicated to the GI endpoint. Significant risk factors, at the 0.20 α level found to be associated with clinically significant blood loss in OA patients included [odds ratio (80% CI)] baseline C-reactive protein (CRP) levels [2.27 (1.46-3.53)], history of gastritis and history of GI intolerance [1.55 (1.06-2.28)], positive Helicobacter pylori at screening [1.54 (1.07-2.22)], increasing age [1.17 (1.04-1.32)] and body mass index [BMI; 1.03 (1.00-1.06)].
Monitoring for decreases in haemoglobin should be considered for all OA patients and especially those with an increased age, BMI, history of gastritis and GI intolerance, CRP levels >1 mg/dL and/or positive H. pylori status, as this may affect their clinical management.
非甾体抗炎药与胃肠道（GI）损伤有关。Celecoxib 与 Omeprazole 和 Diclofenac 用于高危骨关节炎和类风湿关节炎患者（CONDOR）试验表明，血红蛋白下降≥2g/dL 被判定为明确或假定的 GI 来源的复合 GI 主要终点是最常见的组成/事件。这种不良事件在长期 NSAID 治疗中可能具有临床相关性。
确定与血红蛋白/血细胞比容下降相关的潜在危险因素。
对 CONDOR 试验进行事后分析，分析人群为意向治疗人群。临床显著失血定义为：（i）血红蛋白下降≥2g/dL 和/或血细胞比容下降≥10%；（ii）被判定为明确或假定的 GI 来源的失血。通过逐步逻辑回归评估了 15 个危险因素。每个因素都必须在<0.20α时有统计学意义才能纳入模型。
共有 64/3774（1.7%）例骨关节炎（OA）患者出现血红蛋白/血细胞比容下降，并被判定为 GI 终点。在 OA 患者中，与临床显著失血相关的显著危险因素（在 0.20α水平）包括[比值比（80%可信区间）]基线 C 反应蛋白（CRP）水平[2.27（1.46-3.53）]、胃炎病史和 GI 不耐受史[1.55（1.06-2.28）]、筛查时幽门螺杆菌阳性[1.54（1.07-2.22）]、年龄增长[1.17（1.04-1.32）]和体重指数[BMI；1.03（1.00-1.06）]。
应考虑所有 OA 患者监测血红蛋白下降，尤其是年龄较大、BMI 较高、有胃炎和 GI 不耐受史、CRP 水平>1mg/dL 和/或幽门螺杆菌阳性的患者，因为这可能会影响他们的临床管理。
