Post-marketing safety evaluation of mirogabalin using the JADER database

Area of Science:

• Pharmacovigilance and Drug Safety
• Neurology
• Clinical Pharmacology

Background:

• Mirogabalin, a third-generation α2-δ ligand, is approved for diabetic peripheral neuropathic pain (DPNP).
• Its post-marketing safety profile requires further characterization, especially novel adverse event (AE) signals and comparisons with established therapies like pregabalin and gabapentin.

Purpose of the Study:

• To identify and characterize novel AE signals associated with mirogabalin.
• To evaluate demographic differences in AE reporting.
• To compare the safety profile of mirogabalin with pregabalin and gabapentin.

Main Methods:

• Pharmacovigilance analysis of the Japanese Adverse Drug Event Report (JADER) database (January 2019-June 2025).
• Disproportionality analysis using Reporting Odds Ratio (ROR) and Information Component (IC) methods.
• Subgroup analyses (sex, age), sensitivity analyses (monotherapy), and time-to-onset (TTO) analysis were performed.

Main Results:

• Thirty-three positive AE signals were identified from 463 reports, including six novel signals: pleural effusion, contusion, toxic encephalopathy, congestive cardiac failure, deafness, and angioedema.
• Mirogabalin showed significantly higher RORs than pregabalin for pleural effusion, toxic encephalopathy, contusion, and deafness.
• Mirogabalin exhibited higher RORs than gabapentin for congestive cardiac failure. Sex- and age-related differences in AE reporting were observed, with early clustering of AEs (median TTO of 6 days).

Conclusions:

• This study identifies six novel AE signals for mirogabalin and highlights distinct safety profiles compared to pregabalin and gabapentin.
• Demographic-specific monitoring strategies are recommended to enhance patient safety when using mirogabalin.