Evaluation of Risk of Cardiac or Cerebrovascular Events in Romosozumab Users Focusing on Comorbidities: Analysis of the Japanese Adverse Drug Event Report Database.
J Pharm Technol
; 39(1): 23-28, 2023 Feb.
Article
en En
| MEDLINE
| ID: mdl-36755759
Background: Romosozumab is associated with an increased risk of cardiac or cerebrovascular events. Identifying the risk factors for these events could contribute to the safe use of romosozumab. Objective: This study aimed to investigate risk factors for cardiac or cerebrovascular events in romosozumab users. Methods: First, disproportionality analysis was performed to compare the frequency of cardiac or cerebrovascular events, using data from the Japanese Adverse Drug Event Report database. Next, multivariate logistic analysis was performed to investigate risk factors for cardiac or cerebrovascular events in romosozumab users. Results: In total, 859 romosozumab users were identified. A disproportionality of both cardiac and cerebrovascular events was observed in only romosozumab users. Multivariate logistic analysis revealed that the risk of cardiac events in romosozumab users was significantly increased in patients with cardiac disease (odds ratio [OR]: 5.9, 95% confidence interval [CI] 3.5-9.9; P < 0.01) and hypertension (OR: 1.6, 95% CI 1.0-2.7; P = 0.047). In addition, the risk of cerebrovascular events in romosozumab users was significantly increased in the presence of cerebrovascular disease (OR: 2.7, 95% CI 1.2-6.2; P = 0.02) and hypertension (OR: 2.6, 95% CI 1.7-3.9; P < 0.01). Conclusion: Our findings suggest that hypertension may increase the risk of cardiac or cerebrovascular events in romosozumab users. Although additional studies are needed to assess other associated factors, these findings may contribute to the appropriate use of romosozumab and limit adverse events.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
J Pharm Technol
Año:
2023
Tipo del documento:
Article
País de afiliación:
Japón
Pais de publicación:
Estados Unidos