Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2025-05-07 DOI:10.1007/s40122-025-00732-8

Takuya Nikaido, Shunsuke Tabata, Kazuhito Shiosakai, Taichi Nakatani, Hiroshi Sakoda

{"title":"Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study.","authors":"Takuya Nikaido, Shunsuke Tabata, Kazuhito Shiosakai, Taichi Nakatani, Hiroshi Sakoda","doi":"10.1007/s40122-025-00732-8","DOIUrl":null,"url":null,"abstract":"Introduction: 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.Methods: 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).Results: 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).Conclusions: 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.Trial registration: Japan Registry of Clinical Trials (jRCTs021200007).","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":4.1000,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00732-8","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: 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.

Methods: 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).

Results: 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).

Conclusions: 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.

Trial registration: Japan Registry of Clinical Trials (jRCTs021200007).

查看原文本刊更多论文

非甾体抗炎药治疗腰椎管狭窄伴周围神经性疼痛患者米罗巴林的安全性和有效性：米罗塔斯研究的事后分析。

对使用非甾体抗炎药的腰椎管狭窄（LSS）患者进行的MiroTAS研究的初步分析表明，米罗巴林辅助治疗进一步改善了疼痛和生活质量（QOL），没有新的安全性问题。方法: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）（嗜睡、头晕、水肿和外周水肿的组合）的发病时间、影响安全性和有效性的因素，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（通过视觉模拟量表[VAS]）和患者满意度（通过患者总体印象变化[PGIC]评分）之间的关系。结果：110例患者中，不同患者特征的mradr发生率无显著差异。mradr主要发生在米加巴林首次给药及升级期后。从基线到第12周，mradr患者的EQ-5D-5L评分与无mradr患者相比显著提高(差异0.0767；t检验P = 0.0304)。第12周PGIC评分≤3的患者比例在mradr患者中高于无mradr患者。在第12周，通过VAS评分（改善≥20 mm），患者的腿部疼痛减轻的百分比与患者特征没有差异，除了脊柱裂/脊柱滑脱作为并发症。基线SPDQ麻木评分与第12周EQ-5D-5L的改善呈正相关（Spearman等级相关系数0.2811,p = 0.0092）。结论：米罗巴林与mradr发作的特定患者特征无关，无论患者特征如何，对LSS都有效。在第一次给药和增加米罗加巴林后，需要谨慎考虑mradr的发生，但这些可能不会降低生活质量或患者满意度。在生活质量方面，麻木评分高的患者可能更有可能从米罗巴林治疗中获益。试验注册：日本临床试验注册中心（jRCTs021200007）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.