PMID- 33856660
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210730
IS  - 2193-8237 (Print)
IS  - 2193-651X (Electronic)
VI  - 10
IP  - 1
DP  - 2021 Jun
TI  - Switching From Pregabalin to Mirogabalin in Patients with Peripheral Neuropathic 
      Pain: A Multi-Center, Prospective, Single-Arm, Open-Label Study (MIROP Study).
PG  - 711-727
LID - 10.1007/s40122-021-00255-y [doi]
AB  - INTRODUCTION: Mirogabalin, which is a selective ligand of the alpha(2)delta subunit of 
      voltage-gated Ca(2+) channels, was recently approved in Japan for peripheral 
      neuropathic pain. The alpha(2)delta ligands, including mirogabalin and pregabalin, are 
      associated with significant risk of adverse events (AEs) such as somnolence or 
      dizziness, leading to poor compliance and subsequent inefficacy. Safety and 
      efficacy data for switching patients from pregabalin to mirogabalin are scarce. 
      METHODS: This prospective, single-arm, open-label study involving ten 
      participating centers in Japan recruited patients aged >/= 20 years with peripheral 
      neuropathic pain [visual analog scale (VAS) score >/= 40 mm]. Where necessary, 
      patients underwent a 1-week tapering period to reduce their pregabalin dose, 
      after which pregabalin was stopped and mirogabalin dose was increased using a 
      step-wise dose titration. Patients underwent dose increases after the first and 
      second weeks if there were no tolerability issues, followed by the effective 
      doses until the end of the study (4 weeks). The primary endpoint was the 
      incidence of somnolence, dizziness, and peripheral edema; secondary endpoints 
      included changes in VAS score. AEs were monitored for safety. RESULTS: Of 157 
      patients who provided informed consent, 152 patients were enrolled; 136 (89.5%) 
      patients completed the study. The overall incidences of somnolence, dizziness, 
      and peripheral edema were 41.4, 15.8, and 2.6%, respectively. Most patients 
      (> 70%) experienced mild AEs, and one patient experienced a severe AE 
      (dizziness). Most patients (> 70%) were able to achieve dose titration to an 
      effective dose. Overall mean VAS score significantly decreased (Delta15.7 mm, 
      p < 0.0001) by the end of the study. CONCLUSIONS: Mirogabalin switching from 
      pregabalin is well tolerated and effective in pain management for peripheral 
      neuropathic pain using a step-wise titration. TRIAL REGISTRATION: Japan Registry 
      of Clinical Trials (jRCTs031190113).
FAU - Kimura, Yoshiyuki
AU  - Kimura Y
AD  - Department of Anesthesiology, Dokkyo Medical University School of Medicine, 880 
      Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan. 
      y-kimura@dokkyomed.ac.jp.
FAU - Yamaguchi, Shigeki
AU  - Yamaguchi S
AD  - Department of Anesthesiology, Dokkyo Medical University School of Medicine, 880 
      Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan.
FAU - Suzuki, Takahiro
AU  - Suzuki T
AD  - Department of Anesthesiology, Nihon University School of Medicine, 30-1 Oyaguchi 
      Kami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.
FAU - Kato, Jitsu
AU  - Kato J
AD  - Department of Anesthesiology, Nihon University School of Medicine, 30-1 Oyaguchi 
      Kami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.
FAU - Chiba, Satoko
AU  - Chiba S
AD  - Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of 
      Medicine, 3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan.
FAU - Hirakawa, Naomi
AU  - Hirakawa N
AD  - Pain Clinic and Palliative Care Medicine, Saga University Hospital, 5-1-1 
      Nabeshima, Saga City, Saga, 849-8501, Japan.
FAU - Yamaguchi, Keisuke
AU  - Yamaguchi K
AD  - Department of Anesthesiology and Pain Medicine, Juntendo Tokyo Koto Geriatric 
      Medical Center, 3-3-20 Shinsuna, Koto-ku, Tokyo, 136-0075, Japan.
FAU - Tanabe, Yutaka
AU  - Tanabe Y
AD  - Anesthesiology and Pain Medicine, Juntendo University Nerima Hospital, 3-1-10 
      Takanodai, Nerima-ku, Tokyo, 177-8521, Japan.
FAU - Takatsuna, Hiroshi
AU  - Takatsuna H
AD  - Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., 
      3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
FAU - Kenyoshi, Yusuke
AU  - Kenyoshi Y
AD  - Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., 
      3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
FAU - Shiosakai, Kazuhito
AU  - Shiosakai K
AD  - Data Intelligence Department, Digital Transformation Management Division, Daiichi 
      Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
FAU - Sakai, Miyoshi
AU  - Sakai M
AD  - EP-CRSU Co., Ltd., Acropolis Tokyo 3F 6-29 Shin-Ogawamachi Shinjuku-ku, Tokyo, 
      162-0814, Japan.
FAU - Iseki, Masako
AU  - Iseki M
AD  - Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of 
      Medicine, 3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan.
LA  - eng
PT  - Journal Article
DEP - 20210415
PL  - New Zealand
TA  - Pain Ther
JT  - Pain and therapy
JID - 101634491
PMC - PMC8119591
OTO - NOTNLM
OT  - Mirogabalin
OT  - Peripheral neuropathic pain
OT  - Pregabalin
OT  - Switching
OT  - alpha2delta ligands
EDAT- 2021/04/16 06:00
MHDA- 2021/04/16 06:01
PMCR- 2021/04/15
CRDT- 2021/04/15 12:23
PHST- 2020/12/24 00:00 [received]
PHST- 2021/03/10 00:00 [accepted]
PHST- 2021/04/16 06:00 [pubmed]
PHST- 2021/04/16 06:01 [medline]
PHST- 2021/04/15 12:23 [entrez]
PHST- 2021/04/15 00:00 [pmc-release]
AID - 10.1007/s40122-021-00255-y [pii]
AID - 255 [pii]
AID - 10.1007/s40122-021-00255-y [doi]
PST - ppublish
SO  - Pain Ther. 2021 Jun;10(1):711-727. doi: 10.1007/s40122-021-00255-y. Epub 2021 Apr 
      15.