A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
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DOI：
10.5055/jom.2014.0239
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发表时间：
2014-11-01
影响因子：
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通讯作者：
Sommerville, Kenneth W
中科院分区：
文献类型：
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作者：
Arora, Samir;Setnik, Beatrice;Sommerville, Kenneth W
目的：评估盐酸羟考酮和盐酸螯合纳曲酮 (ALO-02) 给药长达 12 个月的长期安全性。设计：开放标签、单组安全性研究。地点：32 个美国研究中心（ClinicalTrials.gov 标识符 NCT01428583）。患者：395 名成人（有阿片类药物使用经验和干预措施：开放标签口服 ALO-02 胶囊，每日剂量范围为 20 至 160 mg 羟考酮，持续长达 12 个月。主要观察指标：不良事件 (AE) 和药物相关 AE 的数量和类型，包括戒断评估（临床阿片戒断量表；COWS），药代动力学、疗效和异常行为（当前阿片类药物滥用测量）。 结果：共有 193 名患者（48.9%）接受 ALO-02 ≥181 天，105 名患者（26.6%）接受 ≥361 天。最常见的治疗中出现的 AE 是恶心（25.3%）、便秘（21.3%）、呕吐（13.9%）和头痛（11.6%）。最常见的药物相关不良事件是便秘（18.0%）、恶心（14.9%）、嗜睡（8.4%）、疲劳（6.8%）、头晕（5.6%）和呕吐（5.1%）。在整个研究期间的每次就诊中，大多数患者（86.6%）的 COWS 最高总分低于轻度戒断症状的水平。通过简短疼痛量表 (BPI-SF) 测量的疼痛严重程度评分随着时间的推移而下降。结论：在使用过阿片类药物和未使用过阿片类药物的 CNCP 人群中，重复服用 ALO-02 长达 12 个月是安全的，且耐受性良好。 ALO-02 表现出与缓释阿片类药物一致的安全性和预期的镇痛功效。按指示服用时，添加隔离纳曲酮对患者没有显着的临床影响。
OBJECTIVE: To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months.DESIGN: Open-label, single-arm safety study.SETTING: Thirty-two US research centers (ClinicalTrials.gov identifier NCT01428583).PATIENTS: Three hundred ninety-five adults (opioid experienced and opioid naive) with moderate-to-severe chronic noncancer pain (CNCP).INTERVENTIONS: Open-label, oral ALO-02 capsules, daily dose ranging from 20 to 160 mg oxycodone for up to 12 months.MAIN OUTCOME MEASURES: Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure).RESULTS: A total of 193 (48.9 percent) patients received ALO-02 for ≥181 days and 105 (26.6 percent) patients for ≥361 days. The most common treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), vomiting (13.9 percent), and headache (11.6 percent). The most common drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS total score below the level for mild withdrawal symptoms at every visit throughout the study. Pain severity scores as measured by the short Form of the Brief Pain Inventory (BPI-SF) decreased over time.CONCLUSIONS: Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naive patients. ALO-02 demonstrated a safety profile consistent with extended-release opioids and the expected analgesic efficacy. The addition of sequestered naltrexone had no significant clinical effect on patients when taken as directed.