Rauck Richard L, Nalamachu Srinivas, Wild James E, Walker George S, Robinson Cynthia Y, Davis Charles S, Farr Stephen J
Carolinas Pain Institute, Center for Clinical Research, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Pain Med. 2014 Jun;15(6):975-85. doi: 10.1111/pme.12377. Epub 2014 Feb 12.
A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP).
This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20-100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction (Subject Global Assessment of Medication) were assessed.
Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids.
Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP.
已研发出一种氢可酮（HC）的单药长效制剂用于治疗慢性中重度疼痛。本研究旨在检验HC长效制剂在有阿片类药物使用经验的中重度慢性下腰痛（CLBP）成人患者中的安全性和有效性。
这项多中心、富集入组、随机撤药研究包括一个开放标签转换/滴定阶段（≤6周），随后是安慰剂对照、双盲治疗阶段（12周）。在转换/滴定阶段，受试者（N = 510）从其当前使用的阿片类药物转换，并滴定至HC长效制剂的稳定剂量（每12小时20 - 100 mg）。在治疗阶段，受试者（每组N = 151）接受HC长效制剂或安慰剂治疗；允许使用解救药物。主要疗效终点是从基线到第85天平均疼痛强度的平均变化。评估缓解率（疼痛改善30%）和满意度（受试者对药物的整体评估）。
两组间人口统计学和基线特征相似。从基线到第85天，HC长效制剂治疗组的平均疼痛强度评分的均值±标准差变化显著低于安慰剂组（0.48 ± 1.56 vs 0.96 ± 1.55；P = 0.008）。治疗组的缓解者显著更多（68% vs 31%；P < 0.001）。受试者对药物的整体评估平均得分显著增加（0.8 ± 1.3 vs 0.0 ± 1.4；P < 0.0001），表明对HC长效制剂的满意度更高。不良事件谱与其他阿片类药物一致。
长效HC耐受性良好且有效，不存在对乙酰氨基酚相关的肝毒性风险，可用于治疗CLBP。
