Premier Research, Austin, TX, USA.
Curr Med Res Opin. 2009 Jun;25(6):1551-61. doi: 10.1185/03007990902952825.
To evaluate the relative efficacy and tolerability of tapentadol immediate release (IR) and oxycodone IR for management of moderate to severe pain following orthopedic surgery (bunionectomy).
Randomized patients (N = 901) received oral tapentadol IR 50 or 75 mg, oxycodone HCl IR 10 mg, or placebo every 4-6 h over a 72-h period following surgery. Acetaminophen (< or =2 g) was allowed in the first 12 h after the first dose of study drug. In the primary analysis, tapentadol IR (50 and 75 mg) was evaluated for efficacy superior to placebo and non-inferior to oxycodone HCl IR 10 mg (using sum of pain intensity difference [SPID] over 48 h), and tolerability superior to oxycodone IR (using incidence of treatment-emergent adverse events [TEAEs] of nausea and/or vomiting).
Statistically significantly higher mean SPID(48) values were observed with tapentadol IR (50 and 75 mg) and oxycodone HCl IR 10 mg than placebo (all p < 0.001). The efficacy of tapentadol IR 50 mg and 75 mg was non-inferior to oxycodone HCl IR 10 mg. The incidence of TEAEs of nausea and/or vomiting was statistically significantly lower with tapentadol IR 50 mg versus oxycodone IR 10 mg (35 vs. 59%; p < 0.001). No statistically significant difference in the incidence of nausea and/or vomiting was observed between tapentadol IR 75 mg and oxycodone IR 10 mg (51 vs. 59%; p = 0.057). A possible limitation of this study was that the intense dose and patient monitoring may not represent real-world situations and may result in higher incidences of TEAEs than expected in a practice setting; this bias would be similar for all treatment groups.
Clinically meaningful and statistically significant improvements were observed with tapentadol IR 50 mg and 75 mg compared with placebo for the relief of moderate-to-severe acute pain after orthopedic surgery. Tapentadol IR 50 mg and 75 mg were non-inferior to oxycodone HCl IR 10 mg for the treatment of acute pain based on the primary efficacy endpoint of SPID(48) and the pre-specified margin of 48 points. The incidence of nausea and/or vomiting was statistically significantly lower for tapentadol IR 50 mg and numerically lower for tapentadol IR 75 mg than for oxycodone HCl IR 10 mg.
评估盐酸他喷他多速释片和盐酸羟考酮速释片治疗骨科手术后（拇囊炎切除术）中度至重度疼痛的相对疗效和耐受性。
随机分组的患者（N=901）在手术后 72 小时内，每 4-6 小时口服他喷他多速释片 50 或 75mg、盐酸羟考酮控释片 10mg 或安慰剂。在首次服用研究药物后的 12 小时内，允许使用对乙酰氨基酚（<或=2g）。在主要分析中，评估了他喷他多速释片（50mg 和 75mg）在疗效方面优于安慰剂，且不劣于盐酸羟考酮控释片 10mg（采用 48 小时内疼痛强度差总和[SPID]），在耐受性方面优于盐酸羟考酮控释片（采用恶心和/或呕吐的治疗中出现的不良事件[TEAEs]发生率）。
与安慰剂相比，他喷他多速释片（50mg 和 75mg）和盐酸羟考酮控释片 10mg 观察到的平均 SPID（48）值显著更高（均 p<0.001）。他喷他多速释片 50mg 和 75mg 的疗效与盐酸羟考酮控释片 10mg 相当。与盐酸羟考酮控释片 10mg 相比，他喷他多速释片 50mg 的恶心和/或呕吐 TEAEs 发生率显著降低（35 对 59%；p<0.001）。他喷他多速释片 75mg 与盐酸羟考酮控释片 10mg 相比，恶心和/或呕吐发生率无统计学差异（51 对 59%；p=0.057）。本研究的一个可能局限性是，高剂量和患者监测可能无法代表实际情况，并且可能导致 TEAEs 发生率高于预期，这种偏倚在所有治疗组中相似。
与安慰剂相比，他喷他多速释片 50mg 和 75mg 可显著改善骨科手术后中度至重度急性疼痛的缓解程度。基于主要疗效终点 SPID（48）和预先指定的 48 分边界，他喷他多速释片 50mg 和 75mg 与盐酸羟考酮控释片 10mg 治疗急性疼痛的疗效相当。与盐酸羟考酮控释片 10mg 相比，他喷他多速释片 50mg 和他喷他多速释片 75mg 的恶心和/或呕吐发生率均显著降低，且他喷他多速释片 75mg 的发生率略有降低。
