Evidence map›Paper›PMID 40332730›Full record

ArticlePain and therapy2025

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

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

Abstract read
In one paragraph

Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Takuya NikaidoDepartment of Orthopaedic Surgery, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan. tnikaido@fmu.ac.jp.
Shunsuke TabataMedical Affairs Planning Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Kazuhito ShiosakaiData Intelligence Department, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
Taichi NakataniCR Data Science Department, Clinical Research Center Real World Evidence Business Headquarters, EPS Corporation, 1-17-6, Esaka-cho, Suita, Osaka, 564-0063, Japan.
Hiroshi SakodaPrimary Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

methodsThis 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).

resultsAmong 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).

conclusionsMirogabalin 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 registrationJapan Registry of Clinical Trials (jRCTs021200007).

Indexed as

EfficacyLumbar spinal stenosisMirogabalinPeripheral neuropathic painPost hoc analysisQuality of lifeSafetyVisual analogue scale

Identifiers

PMID40332730
PMCPMC12279656

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.