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- Title
Evaluation of Risk of Cardiac or Cerebrovascular Events in Romosozumab Users Focusing on Comorbidities: Analysis of the Japanese Adverse Drug Event Report Database.
- Authors
Kotake, Kazumasa; Mitsuboshi, Satoru; Omori, Yuki; Kawakami, Yukio; Kawakami, Yasuhiro
- Abstract
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.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CEREBROVASCULAR disease risk factors; CARDIOVASCULAR diseases risk factors; CONFIDENCE intervals; MULTIPLE regression analysis; MONOCLONAL antibodies; OSTEOPOROSIS; RISK assessment; DESCRIPTIVE statistics; DRUG side effects; ODDS ratio; COMORBIDITY
- Publication
Journal of Pharmacy Technology, 2023, Vol 39, Issue 1, p23
- ISSN
8755-1225
- Publication type
Article
- DOI
10.1177/87551225221144960