Parsons Bruce, Fujii Koichi, Nozawa Kazutaka, Yoshiyama Tamotsu, Ortiz Marie, Whalen Edward
Global Medical Product Evaluation, Pfizer Inc, New York, NY, USA,
Medical Affairs, Pfizer Japan Inc, Shibuya-ku, Tokyo, Japan.
J Pain Res. 2019 Mar 22;12:1061-1068. doi: 10.2147/JPR.S181729. eCollection 2019.
Although analyses of pooled clinical trial data have reported how international populations respond to pregabalin by baseline neuropathic pain (NeP) severity, no studies have evaluated this specifically in patients from Japan. Thus, this post hoc pooled analysis evaluated the efficacy of pregabalin in Japanese subjects for treating moderate or severe baseline NeP.
Data were pooled from three placebo-controlled trials enrolling Japanese subjects with postherpetic neuralgia (PHN), diabetic peripheral neuropathy (DPN), and spinal cord injury (SCI). The efficacy of pregabalin was evaluated by baseline pain severity (moderate or severe NeP). The trials on PHN and DPN included a 1-week titration of pregabalin from 150 mg/day to 300 or 600 mg/day; the SCI trial included a 4-week dose optimization phase (150 mg/day, titrated up to 600 mg/day). Treatment durations were 13-16 weeks (excluding 1-week taper periods), and pregabalin was administered in two divided doses per day.
Mean baseline pain scores and demographic characteristics were comparable between treatment cohorts. Pregabalin treatment significantly reduced pain scores from baseline to endpoint compared with placebo in subjects with both moderate (<0.001) and severe (<0.05) baseline pain. Significant improvements in mean sleep scores from baseline to endpoint were associated with pregabalin compared with placebo in subjects with both moderate and severe baseline pain (both <0.0001). A greater proportion of subjects in both pain cohorts achieved a ≥30% reduction in pain from baseline with pregabalin vs placebo (<0.05). Higher proportions of pregabalin-treated vs placebo-treated subjects shifted to a less severe pain category at endpoint. Consistent with the known safety profile of pregabalin, common adverse events included dizziness, somnolence, weight gain, and peripheral edema.
Pregabalin demonstrated efficacy for pain relief and sleep improvement with a consistent safety profile in Japanese subjects with either moderate or severe baseline pain severity.
NCT0039490130, NCT0055347522, NCT0040774524.
尽管对汇总临床试验数据的分析报告了国际人群根据基线神经性疼痛（NeP）严重程度对普瑞巴林的反应情况，但尚无研究专门针对日本患者进行评估。因此，这项事后汇总分析评估了普瑞巴林在日本受试者中治疗中度或重度基线NeP的疗效。
数据来自三项安慰剂对照试验，这些试验纳入了患有带状疱疹后神经痛（PHN）、糖尿病性周围神经病变（DPN）和脊髓损伤（SCI）的日本受试者。通过基线疼痛严重程度（中度或重度NeP）评估普瑞巴林的疗效。PHN和DPN试验包括将普瑞巴林从150mg/天滴定至300或600mg/天，为期1周；SCI试验包括一个为期4周的剂量优化阶段（150mg/天，滴定至600mg/天）。治疗持续时间为13 - 16周（不包括1周的减量期），普瑞巴林每日分两次给药。
治疗组之间的平均基线疼痛评分和人口统计学特征具有可比性。在中度（<0.001）和重度（<0.05）基线疼痛的受试者中，与安慰剂相比，普瑞巴林治疗可使疼痛评分从基线显著降低至终点。在中度和重度基线疼痛的受试者中，与安慰剂相比，普瑞巴林可使平均睡眠评分从基线至终点有显著改善（均<0.0001）。与安慰剂相比，在两个疼痛组中，使用普瑞巴林的受试者中有更大比例的人疼痛较基线降低了≥30%（<0.05）。在终点时，接受普瑞巴林治疗的受试者转向疼痛较轻类别的比例高于接受安慰剂治疗的受试者。与普瑞巴林已知的安全性特征一致，常见不良事件包括头晕、嗜睡、体重增加和外周水肿。
在基线疼痛严重程度为中度或重度的日本受试者中，普瑞巴林显示出缓解疼痛和改善睡眠的疗效，且安全性特征一致。
NCT0039490130、NCT0055347522、NCT0040774524。
