Scheinberg Morton, Pott Júnior Henrique, Macêdo Eduardo de Almeida, Bocchi de Oliveira Monalisa Fernanda, Ecclissato Christina, Amazonas Roberto Bleuel
Clinical Research Center Hospital AACD, Hospital Israelita Albert Einstein, São Paulo, Brazil.
Medical Affairs Department, EMS Pharma Inc., Hortolândia, Brazil,
Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
This study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms.
Patients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Secondary endpoints were mean visual analog scale score of dyspeptic symptoms (nausea, abdominal discomfort/pain, epigastric burning, postprandial fullness), mean visual analog scale score of individual dyspeptic symptoms, and individual score of dyspeptic symptoms according to patient diary. This study is registered at ClinicalTrials.gov: NCT01670552.
A total of 490 patients were enrolled and randomized, and 399 completed treatment (naproxen/esomeprazole, n=201; nimesulide/pantoprazole, n=198). The difference in mean change in the modified Western Ontario and McMaster Universities Osteoarthritis Index pain score after 7 days of treatment between the two treatment groups was 2.33 mm (95% CI, -1.22 to 5.89 mm). After 14 days of therapy, the difference was 0.45 mm (95% CI, -3.29 to 4.19 mm). The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful.
The present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain.
本研究调查了萘普生/埃索美拉唑镁固定剂量复方片剂和尼美舒利/泮托拉唑的安全性和有效性，以确定这两种治疗方案是否同样适合缓解骨关节炎疾病患者的疼痛和消化不良症状。
患者被随机分配，每天两次接受尼美舒利/泮托拉唑（100毫克/20毫克）或萘普生/埃索美拉唑镁（500毫克/20毫克）治疗，为期14天。主要终点定义为改良的西安大略和麦克马斯特大学骨关节炎指数疼痛子量表的平均变化。次要终点为消化不良症状（恶心、腹部不适/疼痛、上腹部烧灼感、餐后饱胀感）的平均视觉模拟量表评分、个体消化不良症状的平均视觉模拟量表评分以及根据患者日记记录的消化不良症状个体评分。本研究已在ClinicalTrials.gov注册：NCT01670552。
共纳入490例患者并进行随机分组，39９例完成治疗（萘普生/埃索美拉唑组，n = 201；尼美舒利/泮托拉唑组，n = 198）。两个治疗组治疗7天后改良的西安大略和麦克马斯特大学骨关节炎指数疼痛评分的平均变化差异为2.33毫米（95%CI，-1.22至5.89毫米）。治疗14天后，差异为0.45毫米（95%CI，-3.29至4.19毫米）。合并组中最常见的不良事件为腹部不适、腹胀、消化不良和恶心，但这些均未被认为具有临床意义。
本研究表明，与萘普生/埃索美拉唑相比，尼美舒利/泮托拉唑固定剂量联合用药14天治疗骨关节炎疼痛具有非劣效性。
