Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses.
Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses.
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DOI：
10.2337/dc07-2105
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发表时间：
2008-07
期刊：
影响因子：
16.2
通讯作者：
Emir B
中科院分区：
文献类型：
--
作者：
Freeman R;Durso-Decruz E;Emir B
目的-评价普瑞巴林在有效剂量范围内的疗效、安全性和耐受性，确定每日三次（TID）与每日两次（BID）给药方案的疗效差异，并使用7项普瑞巴林治疗疼痛性糖尿病周围神经病变（DPN）试验的数据，采用至事件发生时间分析确定持续治疗效果的起效时间。研究设计和方法--数据汇集在7个双盲、随机、安慰剂对照试验中，使用普瑞巴林治疗疼痛性DPN，剂量为150、300和600 mg/天，TID或BID。只有一项试验包括所有三种剂量，四项试验使用TID给药。所有研究都有相同的基本选择标准，治疗持续时间范围为5至13周。汇总分析显示，普瑞巴林显著降低了与DPN相关的疼痛和疼痛相关的睡眠干扰（150、300和600 mg/天TID给药vs.安慰剂，所有P ≤ 0.007）。BID给药时，仅600 mg/天剂量显示有效性（P ≤ 0.001）。与普瑞巴林相关的疼痛和睡眠干扰减少似乎与剂量呈正相关;在600 mg/天治疗的患者中观察到最大效果。Kaplan-Meier分析显示，至持续（终点时≥30%）1分改善的中位发生时间，接受普瑞巴林600 mg/d治疗的患者为4天，接受普瑞巴林300 mg/d治疗的患者为5天，接受普瑞巴林150 mg/d治疗的患者为13天，接受安慰剂治疗的患者为60天。最常见的治疗后出现的不良事件是头晕、嗜睡和外周水肿。结论：普瑞巴林在其有效剂量范围内治疗与DPN患者疼痛的显著、剂量相关性改善相关。
OBJECTIVE—To evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range, to determine differences in the efficacy of three times daily (TID) versus twice daily (BID) dosage schedules, and to use time-to-event analysis to determine the time to onset of a sustained therapeutic effect using data from seven trials of pregabalin in painful diabetic peripheral neuropathy (DPN). RESEARCH DESIGN AND METHODS—Data were pooled across seven double-blind, randomized, placebo-controlled trials using pregabalin to treat painful DPN with dosages of 150, 300, and 600 mg/day administered TID or BID. Only one trial included all three of these dosages, and TID dosing was used in four. All studies shared fundamental selection criteria, and treatment durations ranged from 5 to 13 weeks. RESULTS—Pooled analysis showed that pregabalin significantly reduced pain and pain-related sleep interference associated with DPN (150, 300, and 600 mg/day administered TID vs. placebo, all P ≤ 0.007). Only the 600 mg/day dosage showed efficacy when administered BID (P ≤ 0.001). Pain and sleep interference reductions associated with pregabalin appear to be positively correlated with dosage; the greatest effect was observed in patients treated with 600 mg/day. Kaplan-Meier analysis revealed that the median time to onset of a sustained (≥30% at end point) 1-point improvement was 4 days in patients treated with pregabalin at 600 mg/day, 5 days in patients treated with pregabalin at 300 mg/day, 13 days in patients treated with pregabalin at 150 mg/day, and 60 days in patients receiving placebo. The most common treatment-emergent adverse events were dizziness, somnolence, and peripheral edema. CONCLUSIONS—Treatment with pregabalin across its effective dosing range is associated with significant, dose-related improvement in pain in patients with DPN.
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