Javed Saad, Alam Uazman, Malik Rayaz A
Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK,
Manchester University Hospital, Manchester, UK,
J Pain Res. 2018 Aug 22;11:1559-1566. doi: 10.2147/JPR.S145999. eCollection 2018.
There are currently no approved disease-modifying therapies for diabetic neuropathy, and there are only 3 US Food and Drug Administration-approved therapies (pregabalin, duloxetine, and tapentadol) for painful diabetic neuropathy. They each have moderate efficacy with adverse effects limiting optimal dose titration. There is a considerable need for new therapies for the management of painful diabetic neuropathy. We reviewed the potential role of mirogabalin, which like gabapentin and pregabalin modulates the alpha-2/delta-1 subunit of the voltage-gated calcium channel, allowing the influx of calcium and release of neurotransmitters at the synaptic cleft in the central nervous system and spinal cord. It has shown efficacy and good tolerability in a Phase II study in diabetic painful neuropathy and based on the results of two Phase III clinical trials in diabetic painful neuropathy and post-herpetic neuralgia, Daiichi Sankyo submitted a marketing application for neuropathic pain in Japan in February 2018. We have also reviewed potential new therapies, currently in Phase II clinical trials that may modify disease and/or relieve neuropathic pain through novel modes of action.
目前尚无获批的用于治疗糖尿病性神经病变的疾病改善疗法，对于疼痛性糖尿病性神经病变，美国食品药品监督管理局仅批准了3种疗法（普瑞巴林、度洛西汀和曲马多）。它们各自的疗效中等，且不良反应限制了最佳剂量滴定。对于疼痛性糖尿病性神经病变的管理，非常需要新的疗法。我们综述了米罗加巴林的潜在作用，它与加巴喷丁和普瑞巴林一样，可调节电压门控钙通道的α-2/δ-1亚基，使钙流入并在中枢神经系统和脊髓的突触间隙释放神经递质。在一项糖尿病性疼痛性神经病变的II期研究中，它已显示出疗效和良好的耐受性，基于两项针对糖尿病性疼痛性神经病变和带状疱疹后神经痛的III期临床试验结果，第一三共于2018年2月在日本提交了神经性疼痛的上市申请。我们还综述了目前处于II期临床试验阶段的潜在新疗法，这些疗法可能通过新的作用方式改善疾病和/或缓解神经性疼痛。
