Janssen Japan , Tokyo , Japan.
Curr Med Res Opin. 2013 Oct;29(10):1399-409. doi: 10.1185/03007995.2013.831816. Epub 2013 Aug 23.
This phase 3 study evaluated the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for the management of moderate to severe, chronic malignant tumor-related cancer pain.
This randomized, double-blind, active-controlled study included Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Patients were randomized (1:1) to receive oral tapentadol ER (25-200 mg bid) or oral oxycodone HCl CR (5-40 mg bid) for 4 weeks of double-blind treatment. ClinicalTrials.gov identifier: NCT01165281.
This study was designed to evaluate the non-inferiority of the efficacy provided by tapentadol ER versus oxycodone CR, based on the mean change in average pain intensity (11 point numerical rating scale) from baseline to the last 3 days of study drug administration. Treatment-emergent adverse events (TEAEs) were recorded throughout the study.
Of the 374 patients who were screened, 343 were randomized and 236 completed treatment. The least-squares mean difference in the change in pain intensity from baseline to the last 3 days of study treatment between tapentadol ER and oxycodone CR was -0.06 (95% confidence interval [CI], -0.506 to 0.383). The upper limit of the 95% CI was <1 (the predefined threshold value for non-inferiority), indicating that tapentadol ER provided analgesic efficacy that was non-inferior to that of oxycodone CR. The percentage of patients reporting at least one TEAE was similar in the tapentadol ER (87.5% [147/168]) and oxycodone CR (90.1% [155/172]) treatment groups, but the incidence of gastrointestinal TEAEs was lower in the tapentadol ER group (55.4% [93/168]) than in the oxycodone CR group (67.4% [116/172]).
Tapentadol ER (25-200 mg bid) provides analgesic efficacy that is non-inferior to that provided by oxycodone HCl CR (5-40 mg bid) for the management of moderate to severe, chronic malignant tumor-related pain, and is well tolerated overall, with a better gastrointestinal tolerability profile than oxycodone CR.
这项 3 期研究评估了与盐酸羟考酮控释片（CR）相比，酒石酸氢可酮控释片（ER）用于治疗中重度慢性恶性肿瘤相关癌痛的疗效和安全性。
本研究为随机、双盲、阳性药物对照研究，纳入了日本和韩国的中重度慢性恶性肿瘤相关疼痛患者。患者随机（1:1）接受酒石酸氢可酮 ER（25-200mg，bid）或盐酸羟考酮 CR（5-40mg，bid）治疗，为期 4 周的双盲治疗。临床试验注册号：NCT01165281。
本研究旨在评估酒石酸氢可酮 ER 与盐酸羟考酮 CR 的疗效非劣效性，主要观察指标为从基线到研究药物治疗最后 3 天平均疼痛强度（11 点数字评分量表）的变化。记录整个研究过程中的治疗中出现的不良事件（TEAEs）。
在 374 例筛选患者中，343 例患者被随机分组，236 例患者完成了治疗。酒石酸氢可酮 ER 和盐酸羟考酮 CR 治疗组从基线到研究药物治疗最后 3 天疼痛强度变化的最小二乘均数差值为-0.06（95%置信区间[-0.506，0.383]）。95%置信区间的上限<1（非劣效性的预设阈值），表明酒石酸氢可酮 ER 的镇痛疗效不劣于盐酸羟考酮 CR。酒石酸氢可酮 ER 治疗组（87.5%[147/168]）和盐酸羟考酮 CR 治疗组（90.1%[155/172]）报告至少 1 例 TEAEs 的患者比例相似，但酒石酸氢可酮 ER 组胃肠道 TEAEs 的发生率（55.4%[93/168]）低于盐酸羟考酮 CR 组（67.4%[116/172]）。
酒石酸氢可酮 ER（25-200mg，bid）用于治疗中重度慢性恶性肿瘤相关疼痛的疗效不劣于盐酸羟考酮 CR（5-40mg，bid），总体耐受良好，胃肠道耐受性优于盐酸羟考酮 CR。
