Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain.
Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain.
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DOI：
10.1186/1471-2377-9-6
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发表时间：
2009-02-10
期刊：
影响因子：
2.6
通讯作者：
Monz B
中科院分区：
文献类型：
--
作者：
Quilici S;Chancellor J;Löthgren M;Simon D;Said G;Le TK;Garcia-Cebrian A;Monz B
在治疗糖尿病周围神经性疼痛（DPNP）的药物之间，很少有直接的正面比较。批准或推荐用于该适应症的药物包括度洛西汀（DLX）、普瑞巴林（PGB）、加巴喷丁（GBP）和阿米替林（AMT）。我们进行了一项间接荟萃分析，比较DLX与PGB和GBP在DPNP中的疗效和耐受性，使用安慰剂作为常见比较物。我们检索了PubMed、EMBASE、CENTRAL数据库和监管网站中评估DPNP中DLX、PGB、GBP和AMT的随机、双盲、安慰剂对照、平行组或交叉临床试验（rct）。使用批准剂量并在5-13周后进行评估的研究组符合条件。疗效标准为：所有三种药物的24小时疼痛严重程度减轻（24 h PS），缓解率（疼痛减轻≥50%）和患者总体改善/改变印象（PGI-I/C）仅用于DLX和PGB。耐受性标准包括：停药、腹泻、头晕、头痛、恶心和嗜睡。与安慰剂进行直接比较，对每种药物至少两项研究报告的终点进行固定效应和随机效应分析。使用贝叶斯模拟对DLX与PGB和GBP进行间接比较。DLX的3项研究、PGB的6项研究、GBP的2项研究和AMT的无研究符合纳入标准。在DLX、PGB和GBP的随机效应和固定效应分析中，它们在所有疗效参数上都优于安慰剂，但存在一些耐受性权衡。DLX与PGB的间接比较发现24 h PS无差异，但PGI-I/C（有利于PGB）和头晕（有利于DLX）的差异明显。DLX与GBP比较，差异无统计学意义。从现有的少数适合间接比较的研究来看，DLX对DPNP的疗效和耐受性与GBP和PGB相当。度洛西汀为这种致残状况提供了一个重要的治疗选择。
Few direct head-to-head comparisons have been conducted between drugs for the treatment of diabetic peripheral neuropathic pain (DPNP). Approved or recommended drugs in this indication include duloxetine (DLX), pregabalin (PGB), gabapentin (GBP) and amitriptyline (AMT). We conducted an indirect meta-analysis to compare the efficacy and tolerability of DLX with PGB and GBP in DPNP, using placebo as a common comparator. We searched PubMed, EMBASE, CENTRAL databases and regulatory websites for randomized, double-blind, placebo-controlled, parallel group or crossover clinical trials (RCTs) assessing DLX, PGB, GBP and AMT in DPNP. Study arms using approved dosages with assessments after 5–13 weeks were eligible. Efficacy criteria were: reduction in 24-hour pain severity (24 h PS) for all three drugs, and response rate (≥ 50% pain reduction) and Patient Global Impression of Improvement/Change (PGI-I/C) for DLX and PGB only. Tolerability criteria included: discontinuation, diarrhoea, dizziness, headache, nausea and somnolence. Direct comparisons versus placebo were conducted with pooled fixed – and random-effects analyses on endpoints reported in at least two studies of each drug. Indirect comparisons were performed between DLX and each of PGB and GBP using Bayesian simulation. Three studies of DLX, six of PGB, two of GBP and none of AMT met the inclusion criteria. In random-effects and fixed-effects analyses of DLX, PGB and GBP, all were superior to placebo for all efficacy parameters, with some tolerability trade-offs. Indirect comparison of DLX with PGB found no differences in 24 h PS, but significant differences in PGI-I/C, favouring PGB, and in dizziness, favouring DLX were apparent. Comparing DLX and GBP, there were no statistically significant differences. From the few available studies suitable for indirect comparison, DLX shows comparable efficacy and tolerability to GBP and PGB in DPNP. Duloxetine provides an important treatment option for this disabling condition.
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