Spine Surgery and Related Research (Oct 2020)

Frequency of Adverse Drug Reactions and Analgesic Effects of Mirogabalin during Treatment of Peripheral Neuropathic Pain: A Retrospective Clinical Investigation

  • Kazuhide Inage,
  • Takeshi Sainoh,
  • Takayuki Fujiyoshi,
  • Takuma Otagiri,
  • Yasuchika Aoki,
  • Masahiro Inoue,
  • Yawara Eguchi,
  • Sumihisa Orita,
  • Yasuhiro Shiga,
  • Masao Koda,
  • Tsutomu Akazawa,
  • Takeo Furuya,
  • Junichi Nakamura,
  • Hiroshi Takahashi,
  • Miyako Suzuki,
  • Satoshi Maki,
  • Hideyuki Kinoshita,
  • Masaki Norimoto,
  • Tomotaka Umimura,
  • Takashi Sato,
  • Masashi Sato,
  • Masahiro Suzuki,
  • Keigo Enomoto,
  • Hiromitsu Takaoka,
  • Norichika Mizuki,
  • Takashi Hozumi,
  • Ryuto Tsuchiya,
  • Geundong Kim,
  • Tomohito Mukaihata,
  • Takahisa Hishiya,
  • Seiji Ohtori

DOI
https://doi.org/10.22603/ssrr.2020-0042
Journal volume & issue
Vol. 4, no. 4
pp. 354 – 357

Abstract

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Introduction: Mirogabalin should be equivalent to pregabalin, but with fewer incidences of adverse drug reactions (ADRs). To verify these benefits in actual clinical trials, our study investigated the frequency of ADRs and mirogabalin's analgesic effects during treatment of peripheral neuropathic pain. Methods: This study included 74 patients with lower limb pain. We surveyed patient reports of ADRs during the follow-up period as the primary endpoint and examined the visual analog scale (VAS) reported for lower limb pain as the secondary endpoint (before administration, and two and four weeks after administration). Results: The occurrence of ADR was 27.0%, like the frequency of ADRs in the clinical trials for other disorders. However, the discontinuation rate of administration was 10.8%, which was significantly lower than the frequency of ADR occurrences. When the analgesic effect was assessed, a significant decrease in the temporal change of VAS for lower limb pain was observed before administration, and two and four weeks after administration. Conclusions: In this study, the occurrence of ADRs reported by the patients was like the frequency of ADRs reported in the clinical trials for other disorders. When assessing the analgesic effect, the temporal change of VAS for lower limb pain was found to decrease significantly before administration, and two and four weeks after administration.

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