Biondi David M, Xiang Jim, Etropolski Mila, Moskovitz Bruce
Therapeutic Area Lead, Neuroscience, Janssen Scientific Affairs, LLC, Raritan, New Jersey.
Associate Director, Biostatistics and Programming, Janssen Research & Development, LLC, Raritan, New Jersey.
J Opioid Manag. 2015 Sep-Oct;11(5):393-403. doi: 10.5055/jom.2015.0289.
Management of chronic pain in elderly adult patients is often complicated by analgesic medication-related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients (≥ 75 years of age) with moderate to severe, chronic osteoarthritis knee or low back pain.
Data were pooled from three similarly designed, randomized, doubleblind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥ 75 years of age were evaluated. Each study consisted of a 3-week titration and 12-week maintenance period. Patients received placebo, tapentadol ER (100-250 mg bid), or oxycodone HCl CR (20-50 mg bid). Tolerability was evaluated using adverse event reporting. Efficacy was evaluated using pain intensity ratings (11-point numerical rating scale).
For patients ≥ 75 years of age (n = 210), incidences of gastrointestinal treatment-emergent adverse events (TEAEs) overall and TEAEs of vomiting and the composite of nausea and/or vomiting were significantly lower in the tapentadol ER group compared with the oxycodone CR group (all p ≤ 0.0206). Tapentadol ER treatment was associated with significant reductions in pain intensity from baseline to week 15 compared with placebo (p = 0.0075); differences between the oxycodone CR and placebo groups failed to reach statistical significance (p = 0.1195), likely related to a higher treatment discontinuation rate in the oxycodone CR group. No significant differences were observed between the tapentadol ER and oxycodone CR groups in the change in pain intensity from baseline to week 15 (p = 0.2135).
In elderly adult patients ≥ 75 years of age with moderate to severe, chronic osteoarthritis knee or low back pain, tapentadol ER (100-250 mg bid) provided significant pain relief compared with placebo and had a better overall gastrointestinal tolerability profile than oxycodone CR.
老年成年患者慢性疼痛的管理常常因止痛药物相关的副作用而变得复杂。这项对汇总数据的事后分析评估了在患有中度至重度慢性膝骨关节炎或腰痛的老年成年患者（≥75岁）中，与羟考酮控释片（CR）相比，曲马多缓释片（ER）的耐受性和镇痛效果。
数据来自三项设计相似、随机、双盲、安慰剂对照和活性药物对照的3期研究，这些研究针对中度至重度慢性膝骨关节炎（NCT00421928、NCT00486811）或腰痛（NCT00449176）使用曲马多缓释片，对≥75岁患者的数据进行了评估。每项研究包括为期3周的滴定期和12周的维持期。患者接受安慰剂、曲马多缓释片（100 - 250 mg，每日两次）或盐酸羟考酮控释片（20 - 50 mg，每日两次）。通过不良事件报告评估耐受性。使用疼痛强度评分（11点数字评分量表）评估疗效。
对于≥75岁的患者（n = 210），与羟考酮控释片组相比，曲马多缓释片组总体胃肠道治疗中出现的不良事件（TEAE）以及呕吐的TEAE和恶心及/或呕吐的复合事件发生率显著更低（所有p≤0.0206）。与安慰剂相比，曲马多缓释片治疗使从基线到第15周的疼痛强度显著降低（p = 0.0075）；羟考酮控释片组与安慰剂组之间的差异未达到统计学显著性（p = 0.1195），这可能与羟考酮控释片组较高的治疗中断率有关。从基线到第15周，曲马多缓释片组与羟考酮控释片组在疼痛强度变化方面未观察到显著差异（p = 0.2135）。
在≥75岁患有中度至重度慢性膝骨关节炎或腰痛的老年成年患者中，与安慰剂相比，曲马多缓释片（100 - 250 mg，每日两次）能显著缓解疼痛，并且总体胃肠道耐受性优于羟考酮控释片。
