Safety of mirogabalin and pregabalin in Japanese patients with neuropathic pain: a retrospective cohort study.
Expert Opin Drug Saf
; 22(9): 841-848, 2023.
Article
em En
| MEDLINE
| ID: mdl-36945742
ABSTRACT
BACKGROUND:
Few studies have compared the safety risks between the gabapentinoids, pregabalin, and mirogabalin in post-marketing clinical settings. We assessed reported events associated with gabapentinoid use in patients with neuropathic pain. RESEARCH DESIGN ANDMETHODS:
We conducted a retrospective cohort study between September 2020 and December 2020 using the community pharmacies records in Japan. The pharmacists identified new vs. prevalent users of mirogabalin and pregabalin in September 2020 and reported data regarding baseline and adverse events to the Japan Pharmaceutical Association using web-based questionnaires. The incidence of events and hazard ratio (HR) were consequently compared.RESULTS:
New users of mirogabalin and pregabalin were identified (n = 1,650 and 2,244; mean age (SD) 69 (15) and 68 (16) years; women 59% and 56%, respectively). Although serious events were not reported, a marked difference in HRs of common adverse events, including somnolence (1.6), dizziness (1.3), nausea (2.8), edema (3.1), and acetaminophen (2.0)/antidepressant (2.4) addition, was observed.CONCLUSION:
No new serious safety concerns were found for mirogabalin and pregabalin use in patients with neuropathic pain, although the HR of some events indicated increased risk among mirogabalin users. However, further studies are needed as estimates for events occurring in small numbers with wide confidence intervals.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Compostos Bicíclicos com Pontes
/
Pregabalina
/
Analgésicos
/
Neuralgia
Tipo de estudo:
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Expert Opin Drug Saf
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Japão