{"title":"以合并症为重点,评估罗莫单抗使用者发生心脏或脑血管事件的风险:日本药物不良事件报告数据库分析》。","authors":"Kazumasa Kotake, Satoru Mitsuboshi, Yuki Omori, Yukio Kawakami, Yasuhiro Kawakami","doi":"10.1177/87551225221144960","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Objective:</b> This study aimed to investigate risk factors for cardiac or cerebrovascular events in romosozumab users. <b>Methods:</b> 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. <b>Results:</b> 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; <i>P</i> < 0.01) and hypertension (OR: 1.6, 95% CI 1.0-2.7; <i>P</i> = 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; <i>P</i> = 0.02) and hypertension (OR: 2.6, 95% CI 1.7-3.9; <i>P</i> < 0.01). <b>Conclusion:</b> 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.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899965/pdf/","citationCount":"2","resultStr":"{\"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\":\"Kazumasa Kotake, Satoru Mitsuboshi, Yuki Omori, Yukio Kawakami, Yasuhiro Kawakami\",\"doi\":\"10.1177/87551225221144960\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background:</b> 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. <b>Objective:</b> This study aimed to investigate risk factors for cardiac or cerebrovascular events in romosozumab users. <b>Methods:</b> 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. <b>Results:</b> 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; <i>P</i> < 0.01) and hypertension (OR: 1.6, 95% CI 1.0-2.7; <i>P</i> = 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; <i>P</i> = 0.02) and hypertension (OR: 2.6, 95% CI 1.7-3.9; <i>P</i> < 0.01). <b>Conclusion:</b> 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.</p>\",\"PeriodicalId\":16796,\"journal\":{\"name\":\"Journal of Pharmacy Technology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2023-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899965/pdf/\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmacy Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/87551225221144960\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/12/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmacy Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/87551225221144960","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/12/28 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 2
摘要
背景罗莫单抗与心脑血管事件风险增加有关。识别这些事件的风险因素有助于安全使用罗莫单抗。研究目的本研究旨在调查罗莫索单抗使用者发生心脏或脑血管事件的风险因素。研究方法首先,利用日本药物不良事件报告数据库中的数据进行了不对称分析,以比较心脑血管事件的发生频率。然后,对罗莫单抗使用者发生心脏或脑血管事件的风险因素进行多变量逻辑分析。研究结果共发现 859 名罗莫单抗使用者。仅在罗莫索珠单抗使用者中观察到心脏和脑血管事件的比例失调。多变量逻辑分析显示,罗莫索单抗使用者发生心脏事件的风险在患有心脏病(赔率[OR]:5.9,95% 置信区间[CI] 3.5-9.9;P < 0.01)和高血压(OR:1.6,95% 置信区间[CI] 1.0-2.7;P = 0.047)的患者中显著增加。此外,如果存在脑血管疾病(OR:2.7,95% CI 1.2-6.2;P = 0.02)和高血压(OR:2.6,95% CI 1.7-3.9;P < 0.01),使用罗莫索单抗的患者发生脑血管事件的风险会显著增加。结论我们的研究结果表明,高血压可能会增加罗莫索单抗使用者发生心脏或脑血管事件的风险。尽管还需要更多的研究来评估其他相关因素,但这些发现可能有助于合理使用罗莫单抗并限制不良事件的发生。
Evaluation of Risk of Cardiac or Cerebrovascular Events in Romosozumab Users Focusing on Comorbidities: Analysis of the Japanese Adverse Drug Event Report Database.
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.
期刊介绍:
For both pharmacists and technicians, jPT provides valuable information for those interested in the entire body of pharmacy practice. jPT covers new drugs, products, and equipment; therapeutic trends; organizational, legal, and educational activities; drug distribution and administration; and includes continuing education articles.