Stratified analyses for selecting appropriate target patients with diabetic peripheral neuropathy for long-term treatment with an aldose reductase inhibitor, epalrestat.
Stratified analyses for selecting appropriate target patients with diabetic peripheral neuropathy for long-term treatment with an aldose reductase inhibitor, epalrestat.
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DOI：
10.1111/j.1464-5491.2008.02490.x
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发表时间：
2008-07
影响因子：
3.5
通讯作者：
Shigeta, Y.
中科院分区：
文献类型：
--
作者：
Hotta, N.;Kawamori, R.;Atsumi, Y.;Baba, M.;Kishikawa, H.;Nakamura, J.;Oikawa, S.;Yamada, N.;Yasuda, H.;Shigeta, Y.
关键词：
全面评估依帕司他（一种醛糖还原酶抑制剂）在改善主观症状和神经功能方面的长期疗效，以确定对依帕司他治疗有反应的糖尿病周围神经病变患者。对醛糖还原酶抑制剂-糖尿病并发症试验（ADCT）中患者的数据进行了分层分析。ADCT包括糖尿病周围神经病变、中位运动神经传导速度≥ 40 m/s和糖化血红蛋白（HbA 1c）≤ 9.0%的患者。分析了患者3年的HbA 1c和主观症状的纵向数据（依帕司他n = 231，对照受试者n = 273）。基于背景变量（血糖控制、视网膜病变或蛋白尿分级）进行分层分析，以检查主观症状与神经功能之间的关系。进行多因素logistic回归分析。分层亚组分析显示，依帕司他在血糖控制良好和糖尿病并发症严重程度较低的患者中的疗效显著更好。在对照组中，无论是否获得症状性获益，神经功能均无改善。在依帕司他组中，症状改善的患者神经功能恶化较少或改善。依帕司他与对照受试者的疗效比值比约为2：1（HbA 1c ≤ 7.0%的患者为4：1）。我们的研究结果表明，依帕司他，一种醛糖还原酶抑制剂，如果用于适当的患者，将提供一种预防和治疗糖尿病神经病变的临床意义。糖尿病Med.25，818-825（2008）
The long-term efficacy of epalrestat, an aldose reductase inhibitor, in improving subjective symptoms and nerve function was comprehensively assessed to identify patients with diabetic peripheral neuropathy who responded to epalrestat treatment. Stratified analyses were conducted on data from patients in the Aldose Reductase Inhibitor—Diabetes Complications Trial (ADCT). The ADCT included patients with diabetic peripheral neuropathy, median motor nerve conduction velocity ≥ 40 m/s and with glycated haemoglobin (HbA1c) ≤ 9.0%. Longitudinal data on HbA1c and subjective symptoms of the patients for 3 years were analysed (epalrestat n = 231, control subjects n = 273). Stratified analyses based on background variables (glycaemic control, grades of retinopathy or proteinuria) were performed to examine the relationship between subjective symptoms and nerve function. Multiple logistic regression analyses were conducted. Stratified subgroup analyses revealed significantly better efficacy of epalrestat in patients with good glycaemic control and less severe diabetic complications. In the control group, no improvement in nerve function was seen regardless of whether symptomatic benefit was obtained. In the epalrestat group, nerve function deteriorated less or improved in patients whose symptoms improved. The odds ratio of the efficacy of epalrestat vs. control subjects was approximately 2 : 1 (4 : 1 in patients with HbA1c ≤ 7.0%). Our results suggest that epalrestat, an aldose reductase inhibitor, will provide a clinically significant means of preventing and treating diabetic neuropathy if used in appropriate patients. Diabet. Med. 25, 818–825 (2008)
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影响因子：
4.2
作者：
Boulton, A J
通讯作者：
Boulton, A J
影响因子：
16.2
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Shigeta, Yukio
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158.5
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Tesfaye, S;Chaturvedi, N;Fuller, JH
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168.9
作者：
Malik, RA;Williamson, S;Boulton, AJM
通讯作者：
Boulton, AJM