Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies

Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more det...

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Bibliographic Details
Published in:Clinical therapeutics 2021-05, Vol.43 (5), p.822-835.e16
Main Authors: Kato, Jitsu, Baba, Masayuki, Kuroha, Masanori, Kakehi, Yoshihiro, Murayama, Emiko, Wasaki, Yosuke, Ohwada, Shoichi
Format: Article
Language:English
Subjects:
Adverse events
Alpha 2 delta (α2δ) ligand
Analgesics
Diabetes mellitus
Diabetic neuropathy
Dosage
Drug dosages
Edema
Informed consent
Ligands
Mirogabalin
Nervous system
Neuralgia
Pain
Patients
Peripheral neuropathic pain
Phase III study
Placebos
Pooled analysis
Questionnaires
Safety
Statistical analysis
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Summary:Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin's safety and efficacy. Data were pooled from 2 multicenter, double-blind, placebo-controlled, parallel-group, 14-week treatment studies of mirogabalin conducted at ∼350 study sites (Japan, South Korea, Taiwan, Singapore, Malaysia, and Thailand). Eligible patients in both studies were randomized in a 2:1:1:1 ratio, stratified according to a baseline average daily pain score (ADPS) of
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2021.03.015