Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-12 DOI:10.1007/s40122-025-00722-w

Takashi Hirai, Atsushi Okawa, Hiroshi Takahashi, Kazuhito Shiosakai, Toshitaka Yoshii

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引用次数: 0

Abstract

Introduction: There are few studies of pharmacotherapy of neuropathic pain in cervical spondylotic radiculopathy (CSR). Miro-Cens aimed to examine the efficacy and safety of mirogabalin for treating pain in patients with CSR on non-steroidal anti-inflammatory drugs (NSAIDs), compared with NSAIDs alone.

Methods: Miro-Cens was a 12-week, multicenter, randomized, controlled, open-label, interventional study in Japan. Eligible patients with CSR having upper limb pain (visual analog scale score ≥ 40 mm) were randomly assigned in a 1:1 ratio to the mirogabalin add-on to NSAIDs group and the NSAIDs alone group. The primary endpoint was the change in the weekly average numerical rating scale (NRS) score for upper limb pain from baseline at Week 12.

Results: The mirogabalin add-on group and NSAIDs alone group included 72 and 70 patients, respectively. The mirogabalin add-on group had a significantly greater reduction in the NRS score for upper limb pain than the NSAIDs alone group: estimated changes from baseline at Week 12, - 2.63 [95% confidence interval (CI) - 3.14, - 2.11] in the mirogabalin add-on group; - 1.07 (- 1.62, - 0.53) in the NSAIDs alone group; intergroup difference, - 1.55 (- 2.31, - 0.80; p < 0.001). The responder rate on the NRS score at Week 12 was significantly higher in the mirogabalin add-on group than in the NSAIDs alone group: ≥ 30% improvement, 71.7% vs. 39.6%; ≥ 50% improvement, 58.3% vs. 22.6% (both p < 0.001). The frequent treatment-emergent adverse drug reactions in the mirogabalin add-on group were the known ones (somnolence and dizziness), with most being mild or moderate in severity.

Conclusion: In patients with CSR, combination therapy with mirogabalin and NSAIDs significantly improved neuropathic pain compared with NSAID monotherapy. No new safety concerns were identified, although caution should be exercised regarding somnolence and dizziness. These findings suggest that concomitant use of mirogabalin with NSAIDs could be tolerable and a novel treatment option for CSR patients with insufficient analgesic effects on NSAIDs.

Trial registration number: jRCTs031210629.

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米罗巴林治疗神经根型颈椎病神经性疼痛的疗效和安全性：一项随机、对照、介入性研究。

摘要：神经根型颈椎病（CSR）神经性疼痛的药物治疗研究较少。micro - cens旨在比较非甾体抗炎药（NSAIDs）治疗CSR患者疼痛的疗效和安全性。方法：micro - cens是一项在日本进行的为期12周、多中心、随机、对照、开放标签、介入性研究。符合条件的伴有上肢疼痛的CSR患者（视觉模拟量表评分≥40 mm）按1:1的比例随机分配到米罗巴林加用非甾体抗炎药组和单独使用非甾体抗炎药组。主要终点是第12周时上肢疼痛的每周平均数值评定量表（NRS）评分从基线的变化。结果：米罗巴林加用组和非甾体抗炎药单用组分别有72例和70例患者。与非甾体抗炎药单独治疗组相比，米罗加巴林治疗组上肢疼痛的NRS评分显著降低：米罗加巴林治疗组在第12周与基线相比的估计变化为- 2.63[95%可信区间(CI) - 3.14, - 2.11]；非甾体抗炎药组为- 1.07 (- 1.62,- 0.53)；组间差异：- 1.55 (- 2.31,- 0.80；结论：在CSR患者中，与非甾体抗炎药单药治疗相比，米罗巴林和非甾体抗炎药联合治疗可显著改善神经性疼痛。没有发现新的安全隐患，但应注意嗜睡和头晕。这些研究结果表明，对于非甾体抗炎药镇痛效果不足的CSR患者，同时使用米罗巴林是可以耐受的，是一种新的治疗选择。试验注册号：jRCTs031210629。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pain and Therapy CLINICAL NEUROLOGY-

CiteScore

6.60

自引率

5.00%

发文量

110

审稿时长

6 weeks

期刊介绍： Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.