Clinical Development and Operations, Pfizer Inc., Durham, NC, USA.
Pfizer Inc., Durham, NC, USA.
Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.
To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain. Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged ≥18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into ≥65 years and <65 years age groups. Treatment-emergent adverse events (TEAEs), use of concomitant medications, clinical laboratory measurements, and occurrences of opioid withdrawal using reported adverse events (AEs) and Clinical Opiate Withdrawal Scale (COWS) scores assessed safety. Data pooling was employed for the titration and maintenance phases of both studies. Respectively 805 and 436 patients received ≥1 dose of ALO-02 in the titration and maintenance phases; 121 (15.0%) and 83 (14.6%) patients, respectively, were aged ≥65 years in the titration and maintenance phases. Average doses of ALO-02 were lower in the older patients in both phases. Incidences of TEAEs were comparable between age groups in both phases and generally lower in the maintenance phase. Concomitant medications were taken more often by patients aged ≥65 years. Incidences of potentially clinically significant laboratory results were low in both phases with no clinically important differences between age groups. There were few reports of opioid withdrawal events as assessed by reported AEs and COWS scores. One patient aged ≥65 years experienced an AE of opioid withdrawal. The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain. NCT01571362, NCT01428583.
评估盐酸羟考酮和盐酸纳曲酮隔离物（一种阿片类药物滥用防御制剂）在慢性疼痛患者中的安全性和耐受性是否受年龄影响。对两项慢性下背痛或慢性非癌痛患者的临床研究数据进行分析。≥18 岁、需长期持续使用阿片类药物镇痛的患者分为≥65 岁和＜65 岁年龄组。使用治疗中出现的不良事件（TEAEs）、伴随药物使用、临床实验室检测值，以及报告的不良事件（AE）和临床阿片戒断量表（COWS）评分中出现的阿片类药物戒断情况评估安全性。对两项研究的滴定和维持阶段数据进行合并分析。分别有 805 例和 436 例患者在滴定和维持阶段接受了≥1 剂 ALO-02；分别有 121 例（15.0%）和 83 例（14.6%）≥65 岁的患者在滴定和维持阶段接受治疗。在两个阶段，老年患者的 ALO-02 平均剂量均较低。在两个阶段，年龄组之间 TEAEs 的发生率相似，且在维持阶段发生率更低。≥65 岁患者更常使用伴随药物。在两个阶段，潜在具有临床意义的实验室结果发生率均较低，且年龄组之间无显著差异。AE 和 COWS 评分评估的阿片类药物戒断事件报告较少。一名≥65 岁患者出现阿片类药物戒断事件的 AE。在慢性疼痛患者中，≥65 岁患者和＜65 岁患者使用 ALO-02 的安全性和耐受性相似。NCT01571362，NCT01428583。
