PMID- 38225552 OWN - NLM STAT- MEDLINE DCOM- 20240117 LR - 20240118 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 24 IP - 1 DP - 2024 Jan 15 TI - Efficacy and safety of add-on mirogabalin to conventional therapy for the treatment of peripheral neuropathic pain after thoracic surgery: the multicenter, randomized, open-label ADMIT-NeP study. PG - 80 LID - 10.1186/s12885-023-11708-2 [doi] LID - 80 AB - BACKGROUND: For chronic pain after thoracic surgery, optimal timing of its diagnosis and effective treatment remains unresolved, although several treatment options are currently available. We examined the efficacy and safety of mirogabalin, in combination with conventional pain therapy (nonsteroidal anti-inflammatory drugs and/or acetaminophen), for treating peripheral neuropathic pain (NeP) after thoracic surgery. METHODS: In this multicenter, randomized, open-label, parallel-group study, patients with peripheral NeP were randomly assigned 1:1 to mirogabalin as add-on to conventional therapy or conventional treatment alone. RESULTS: Of 131 patients of consent obtained, 128 were randomized (mirogabalin add-on group, 63 patients; conventional treatment group, 65 patients). The least squares mean changes (95% confidence interval [CI]) in Visual Analogue Scale (VAS) score for pain intensity at rest from baseline to Week 8 (primary endpoint) were - 51.3 (- 54.9, - 47.7) mm in the mirogabalin add-on group and - 47.7 (- 51.2, - 44.2) mm in the conventional group (between-group difference: - 3.6 [95% CI: - 8.7, 1.5], P = 0.161). However, in patients with Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) score (used for the screening of NeP) >/= 12 at baseline, the greater the S-LANSS score at baseline, the greater the decrease in VAS score in the mirogabalin add-on group, while no such trend was observed in the conventional treatment group (post hoc analysis). This between-group difference in trends was statistically significant (interaction P value = 0.014). Chronic pain was recorded in 7.9% vs. 16.9% of patients (P = 0.171) at Week 12 in the mirogabalin add-on vs. conventional treatment groups, respectively. Regarding activities of daily living (ADL) and quality of life (QOL), changes in Pain Disability Assessment Scale score and the EQ-5D-5L index value from baseline to Week 8 showed significant improvement in the mirogabalin add-on group vs. conventional treatment group (P < 0.001). The most common adverse events (AEs) in the mirogabalin add-on group were dizziness (12.7%), somnolence (7.9%), and urticaria (3.2%). Most AEs were mild or moderate in severity. CONCLUSIONS: Addition of mirogabalin to conventional therapy did not result in significant improvement in pain intensity based on VAS scores, but did result in significant improvement in ADL and QOL in patients with peripheral NeP after thoracic surgery. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs071200053 (registered 17/11/2020). CI - (c) 2024. The Author(s). FAU - Miyazaki, Takuro AU - Miyazaki T AD - Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. AD - Department of Thoracic Surgery, Sasebo City General Hospital, Sasebo, Japan. FAU - Matsumoto, Keitaro AU - Matsumoto K AD - Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. FAU - Sato, Toshihiko AU - Sato T AD - Department of General Thoracic, Breast, and Pediatric Surgery, Fukuoka University School of Medicine, Fukuoka, Japan. FAU - Sano, Isao AU - Sano I AD - Department of Respiratory Surgery, The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan. FAU - Furukawa, Katsuro AU - Furukawa K AD - Department of Thoracic Surgery, Ehime Prefectural Central Hospital, Matsuyama, Japan. FAU - Shimoyama, Koichiro AU - Shimoyama K AD - Chest Surgery, National Hospital Organization Nagasaki Medical Center, Omura, Japan. FAU - Kamohara, Ryotaro AU - Kamohara R AD - Department of Thoracic Surgery, Oita Prefectural Hospital, Oita, Japan. FAU - Suzuki, Makoto AU - Suzuki M AD - Department of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan. FAU - Kondou, Masamichi AU - Kondou M AD - Department of Thoracic and Breast Surgery, Ureshino Medical Center, Ureshino, Japan. FAU - Ikeda, Norihiko AU - Ikeda N AD - Department of Surgery, Tokyo Medical University, Tokyo, Japan. FAU - Tabata, Shunsuke AU - Tabata S AD - Primary Medical Science Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan. FAU - Shiosakai, Kazuhito AU - Shiosakai K AD - Data Intelligence Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan. FAU - Nagayasu, Takeshi AU - Nagayasu T AD - Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan. nagayasu@nagasaki-u.ac.jp. CN - ADMIT-NeP Study group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20240115 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - S7LK2KDM5U (mirogabalin) RN - 0 (Bridged Bicyclo Compounds) SB - IM MH - Humans MH - Quality of Life MH - Activities of Daily Living MH - *Thoracic Surgery MH - *Chronic Pain MH - *Neuralgia/drug therapy/etiology MH - Treatment Outcome MH - *Bridged Bicyclo Compounds PMC - PMC10788972 OTO - NOTNLM OT - Chronic postsurgical pain OT - Mirogabalin OT - Post thoracotomy pain syndrome OT - Postoperative neuropathic pain OT - Thosracic surgery COIS- Takuro Miyazaki, Katsuro Furukawa, Ryotaro Kamohara, and Takeshi Nagayasu received lecture fees from Daiichi Sankyo Co., Ltd. Shunsuke Tabata and Kazuhito Shiosakai are employees of Daiichi Sankyo Co., Ltd. Keitaro Matsumoto, Toshihiko Sato, Isao Sano, Koichiro Shimoyama, Makoto Suzuki, Masamichi Kondou, and Norihiko Ikeda have no competing interests to be declared. FIR - Doi, Ryoichiro IR - Doi R FIR - Waseda, Ryuichi IR - Waseda R FIR - Nakamura, Akihiro IR - Nakamura A FIR - Akao, Keiko IR - Akao K FIR - Hatachi, Go IR - Hatachi G FIR - Tagawa, Tsutomu IR - Tagawa T FIR - Imai, Makoto IR - Imai M FIR - Ikeda, Koei IR - Ikeda K FIR - Hagiwara, Masaru IR - Hagiwara M EDAT- 2024/01/16 00:42 MHDA- 2024/01/17 06:42 PMCR- 2024/01/15 CRDT- 2024/01/15 23:33 PHST- 2023/07/31 00:00 [received] PHST- 2023/12/03 00:00 [accepted] PHST- 2024/01/17 06:42 [medline] PHST- 2024/01/16 00:42 [pubmed] PHST- 2024/01/15 23:33 [entrez] PHST- 2024/01/15 00:00 [pmc-release] AID - 10.1186/s12885-023-11708-2 [pii] AID - 11708 [pii] AID - 10.1186/s12885-023-11708-2 [doi] PST - epublish SO - BMC Cancer. 2024 Jan 15;24(1):80. doi: 10.1186/s12885-023-11708-2.