Topiramate vs placebo in painful diabetic neuropathy - Analgesic and metabolic effects
Topiramate vs placebo in painful diabetic neuropathy - Analgesic and metabolic effects
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DOI：
10.1212/01.wnl.0000137341.89781.14
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发表时间：
2004-09-14
期刊：
影响因子：
9.9
通讯作者：
Vinik, AI
中科院分区：
文献类型：
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作者：
Raskin, P;Donofrio, PD;Vinik, AI
背景资料：使用相同的方法，三个同时进行的托吡酯治疗疼痛性糖尿病神经病变（PDN）的安慰剂对照试验没有达到显著性。这项独立但同时进行的安慰剂对照试验使用不同的方法评估托吡酯在PDN中的疗效和耐受性。研究方法：这项为期12周的多中心、随机、双盲试验纳入了323例PDN和疼痛视觉模拟（PVA）评分至少为40的受试者，评分范围为0（无疼痛）至100（可能的最严重疼痛）。托吡酯（n = 214）或安慰剂（n = 109）滴定至400 mg每日或最大耐受剂量。仅在前6周内允许使用短效补救镇痛剂。结果：除平均体重（托吡酯，101.4 kg;安慰剂，95.7 kg; p = 0.028）外，两组的基线特征相似。托吡酯治疗12周后PVA量表评分（从68.0降至46.2 mm）比安慰剂组（从69.1降至54.0 mm; p = 0.038）更有效。50%的托吡酯治疗受试者和34%的安慰剂治疗受试者对治疗有反应，定义为PVA量表评分降低> 30%（p = 0.004）。托吡酯单药治疗也降低了最严重的疼痛强度（p = 0.003 vs安慰剂）和睡眠中断（p = 0.020 vs安慰剂）。腹泻、食欲不振和嗜睡是托吡酯组最常见的不良事件。托吡酯减轻体重（-2.6 vs + 0.2 kg安慰剂; p < 0.001），而不影响血糖控制。结论：托吡酯单药治疗疼痛性糖尿病神经病变患者比安慰剂更有效地减轻疼痛和体重。
Background: Using identical methods, three simultaneous placebo-controlled trials of topiramate for painful diabetic neuropathy (PDN) did not reach significance. This independent yet concurrent placebo-controlled trial used different methods to assess topiramate efficacy and tolerability in PDN. Methods: This 12-week, multicenter, randomized, double-blind trial included 323 subjects with PDN and pain visual analog (PVA) score of at least 40 on a scale from 0 ( no pain) to 100 ( worst possible pain). Topiramate (n = 214) or placebo ( n = 109) was titrated to 400 mg daily or maximum tolerated dose. Short-acting rescue analgesics were permitted only during the first 6 weeks. Results: Baseline characteristics were comparable between groups except for mean body weight ( topiramate, 101.4 kg; placebo, 95.7 kg; p = 0.028). Twelve weeks of topiramate treatment reduced PVA scale score ( from 68.0 to 46.2 mm) more effectively than placebo ( from 69.1 to 54.0 mm; p = 0.038). Fifty percent of topiramate-treated subjects and 34% of placebo-treated subjects responded to treatment, defined as > 30% reduction in PVA scale score ( p = 0.004). Topiramate monotherapy also reduced worst pain intensity ( p = 0.003 vs placebo) and sleep disruption ( p = 0.020 vs placebo). Diarrhea, loss of appetite, and somnolence were the most commonly reported adverse events in the topiramate group. Topiramate reduced body weight ( - 2.6 vs + 0.2 kg for placebo; p < 0.001) without disrupting glycemic control. Conclusions: Topiramate monotherapy reduced pain and body weight more effectively than placebo in patients with painful diabetic neuropathy.