Nikaido Takuya, Tabata Shunsuke, Shiosakai Kazuhito, Nakatani Taichi, Sakoda Hiroshi
Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan.
Medical Affairs Planning Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Pain Ther. 2025 May 7. doi: 10.1007/s40122-025-00732-8.
The primary analysis of the MiroTAS study in patients with lumbar spinal stenosis (LSS) taking non-steroidal anti-inflammatory drugs showed that mirogabalin add-on therapy further improved pain and quality of life (QOL) without new safety concerns.
This post hoc analysis of the MiroTAS study examined the timing of onset of mirogabalin-related adverse drug reactions (mrADRs) (composite of somnolence, dizziness, edema, and peripheral edema), factors affecting safety and efficacy, and the relationships between baseline numbness severity (by spine painDETECT questionnaire [SPDQ] score), EQ-5D-5L scores, leg pain improvement (by visual analogue scale [VAS]), and patient satisfaction (by Patient Global Impression of Change [PGIC] scores).
Among 110 patients, there were no significant differences in the incidence rates of mrADRs by patient characteristics. The mrADRs occurred mainly after the first administration and uptitration period of mirogabalin. EQ-5D-5L scores significantly improved from baseline to week 12 in patients with mrADRs vs those without (difference 0.0767; p = 0.0304 by t test). The proportion of patients with PGIC scores ≤ 3 at week 12 was numerically higher in patients with mrADRs vs those without. There were no differences in the percentage of patients with reduced leg pain by VAS score (improvement ≥ 20 mm) at week 12 by patient characteristics except for spondylolysis/spondylolisthesis as a complication. Baseline SPDQ numbness scores were positively correlated with improvement in EQ-5D-5L at week 12 (Spearman's rank correlation coefficient 0.2811, p = 0.0092).
Mirogabalin was not related to specific patient characteristics regarding the onset of mrADRs and was effective for LSS regardless of patient characteristics. Caution is needed regarding the onset of mrADRs after first administration and uptitration of mirogabalin, but these may not reduce QOL or patient satisfaction. Patients with high numbness scores may be more likely to benefit from treatment with mirogabalin in terms of QOL.
Japan Registry of Clinical Trials (jRCTs021200007).
对服用非甾体抗炎药的腰椎管狭窄症（LSS）患者进行的MiroTAS研究的初步分析表明，加用米罗加巴林治疗可进一步改善疼痛和生活质量（QOL），且无新的安全问题。
这项对MiroTAS研究的事后分析检查了米罗加巴林相关药物不良反应（mrADR，包括嗜睡、头晕、水肿和外周水肿的综合表现）的发生时间、影响安全性和疗效的因素，以及基线麻木严重程度（通过脊柱疼痛检测问卷[SPDQ]评分）、EQ-5D-5L评分、腿部疼痛改善情况（通过视觉模拟量表[VAS]）和患者满意度（通过患者总体变化印象[PGIC]评分）之间的关系。
在110例患者中，mrADR的发生率在不同患者特征之间无显著差异。mrADR主要发生在米罗加巴林首次给药和剂量滴定期之后。与无mrADR的患者相比，有mrADR的患者从基线到第12周时EQ-5D-5L评分显著改善（差异为0.0767；t检验p = 0.0304）。在第12周时，PGIC评分≤3的患者比例在有mrADR的患者中在数值上高于无mrADR的患者。除了作为并发症的椎弓根峡部裂/脊椎滑脱外，在第12周时，根据患者特征，通过VAS评分（改善≥20 mm）使腿部疼痛减轻的患者百分比无差异。基线SPDQ麻木评分与第12周时EQ-5D-5L的改善呈正相关（Spearman等级相关系数0.2811，p = 0.0092）。
就mrADR的发生而言，米罗加巴林与特定患者特征无关，且对LSS患者有效，无论患者特征如何。在米罗加巴林首次给药和剂量滴定后，需要注意mrADR的发生，但这些可能不会降低生活质量或患者满意度。麻木评分高的患者在生活质量方面可能更有可能从米罗加巴林治疗中获益。
日本临床试验注册中心（jRCTs021200007）
