2019
DOI: 10.1111/jdi.13013
|View full text |Cite
|
Sign up to set email alerts
|

Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double‐blind, placebo‐controlled phase III study in Asian patients

Abstract: Aims/Introduction This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α2δ subunit of voltage‐dependent Ca2+ channels, for the treatment of diabetic peripheral neuropathic pain (DPNP). Materials and Methods During this double‐blind, multisite, placebo‐controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30 mg/day for up to 14 weeks, with a 1‐ to 2‐week titration (… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
2
1

Citation Types

21
113
5

Year Published

2019
2019
2024
2024

Publication Types

Select...
6
1
1

Relationship

2
6

Authors

Journals

citations
Cited by 86 publications
(139 citation statements)
references
References 27 publications
21
113
5
Order By: Relevance
“…It shows potent and long‐lasting analgesic effects in rat models for neuropathic pain and a wider safety margin for CNS side‐effects. In the preceding double‐blind phase III trial in Asian patients with DPNP, mirogabalin 15–30 mg/day was well tolerated and relieved DPNP in a dose‐dependent manner for up to 14 weeks. In the present open‐label extension study, the safety and efficacy of mirogabalin (administered using a flexible dosing of 10 or 15 mg twice daily) was shown over a longer period (52 weeks) in patients with DPNP, with >80% of the patients completing the extension study.…”
Section: Discussionmentioning
confidence: 58%
See 2 more Smart Citations
“…It shows potent and long‐lasting analgesic effects in rat models for neuropathic pain and a wider safety margin for CNS side‐effects. In the preceding double‐blind phase III trial in Asian patients with DPNP, mirogabalin 15–30 mg/day was well tolerated and relieved DPNP in a dose‐dependent manner for up to 14 weeks. In the present open‐label extension study, the safety and efficacy of mirogabalin (administered using a flexible dosing of 10 or 15 mg twice daily) was shown over a longer period (52 weeks) in patients with DPNP, with >80% of the patients completing the extension study.…”
Section: Discussionmentioning
confidence: 58%
“…The protocol for the phase III study has been described elsewhere. Briefly, in the double‐blind, placebo‐controlled, parallel‐group study, 834 patients were randomized to receive fixed‐dosage mirogabalin 15, 20 or 30 mg/day, or placebo.…”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…Mirogabalin, a ligand for the α2δ subunit (α2δ-1 and α2δ-2) of voltage-sensitive calcium channels in the CNS, was approved as a medication for pain relief in patients with peripheral neuropathic pain in 2019 in Japan. Mirogabalin reportedly relieved diabetic peripheral neuropathic pain in a dose-dependent manner in Asian patients with diabetic peripheral neuropathic pain and was associated with only mild adverse events [30]. It was also shown to be effective and well tolerated in the management of postherpetic neuralgia in Asian patients [31].…”
Section: Discussionmentioning
confidence: 99%
“…Mirogabalin besylate (herein referred to as mirogabalin; Daiichi Sankyo Co., Ltd., Tokyo, Japan) was developed for the treatment of peripheral neuropathic pain, and was recently approved for this indication in Japan, based on the results of phase 3 studies [18][19][20]. Mirogabalin is an orally administered gabapentinoid that acts via a 2 d calcium channel subunits to modulate pain transmission and processing [21].…”
Section: Introductionmentioning
confidence: 99%