Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY

Pain and Therapy Pub Date : 2024-10-01 Epub Date: 2024-07-04 DOI:10.1007/s40122-024-00616-3

Koichi Hosomi, Yoichi Katayama, Hiroshi Sakoda, Kunika Kikumori, Masanori Kuroha, Takahiro Ushida

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引用次数: 0

Abstract

Introduction: Central post-stroke pain (CPSP) is a common type of central neuropathic pain (CNeP) that can occur following the onset of stroke. The oral gabapentinoid mirogabalin besylate (mirogabalin) is a selective α₂δ ligand that is effective for the treatment of CNeP, including CPSP. However, it is unknown whether the analgesic effect of mirogabalin on CPSP varies in patients with different background factors.

Methods: This was a post hoc subgroup analysis of a multinational, open-label, long-term phase 3 study of mirogabalin for the treatment of CNeP conducted between March 2019 and December 2020. Data from patients with CPSP were stratified by type of stroke (ischemic or hemorrhagic), stroke location (thalamus, putamen, brainstem, or other), presence/absence of motor weakness, median time since stroke (≥ 59 or < 59 months), and median duration of CPSP (≥ 55.5 or < 55.5 months). Efficacy was assessed with the short-form McGill Pain Questionnaire (SF-MPQ), and treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were recorded.

Results: This subanalysis included all 94 patients with CPSP from the phase 3 study; all were Japanese, and the mean age was 65.3 years. The least squares mean change [95% confidence interval] in SF-MPQ visual analog scale (VAS) score from baseline at week 52 (last observation carried forward) was - 17.0 [- 22.1, - 11.9] mm. Among the subgroups, least squares mean changes in SF-MPQ VAS scores were not different. Most TEAEs were mild or moderate; severe TEAEs occurred in six patients (6.4%). Somnolence (25.5%), peripheral edema (13.8%), dizziness (11.7%), and weight gain (6.4%) were the most common ADRs, and the types and frequencies of ADRs were similar among subgroups.

Conclusion: Mirogabalin was generally effective and well tolerated in patients with CPSP, regardless of background factors such as stroke type or location, presence/absence of motor weakness, time since stroke, and duration of CPSP.

Trial registration: Trial registration number NCT03901352.

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米罗加滨对中风后中枢神经痛的疗效：按中风类型和部位对 3 期研究进行事后分析

导言：中风后中枢神经痛（CPSP）是一种常见的中枢神经病理痛（CNeP），可在中风发作后出现。口服加巴喷丁类药物苯乙酸米罗加巴林（mirogabalin besylate）是一种选择性α2δ配体，可有效治疗中枢神经痛，包括中枢性卒中后疼痛。然而，mirogabalin 对 CPSP 的镇痛效果在具有不同背景因素的患者中是否存在差异尚不清楚：这是对2019年3月至2020年12月期间进行的一项米罗卡滨治疗中枢神经痛的多国、开放标签、长期3期研究进行的一项事后亚组分析。根据卒中类型（缺血性或出血性）、卒中位置（丘脑、普鲁士门、脑干或其他）、是否存在运动无力、卒中后中位时间（≥ 59 或结果）对 CPSP 患者的数据进行了分层：本子分析包括第 3 期研究中的全部 94 名 CPSP 患者；所有患者均为日本人，平均年龄为 65.3 岁。第52周（最后一次观察结转）SF-MPQ视觉模拟量表（VAS）评分与基线相比的最小二乘法平均变化[95%置信区间]为-17.0 [- 22.1, - 11.9]毫米。在各亚组中，SF-MPQ VAS 评分的最小二乘法平均变化没有差异。大多数 TEAE 为轻度或中度；6 名患者（6.4%）出现严重 TEAE。嗜睡（25.5%）、外周水肿（13.8%）、头晕（11.7%）和体重增加（6.4%）是最常见的不良反应，各亚组间不良反应的类型和频率相似：米罗加滨对CPSP患者普遍有效且耐受性良好，与卒中类型或部位、是否存在运动无力、卒中后时间和CPSP持续时间等背景因素无关：试验注册：试验注册号 NCT03901352。

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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.