2014年至2021年间美国批准的心血管疾病药物的安全性:药物警戒分析。

IF 1.8 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Expert Review of Cardiovascular Therapy Pub Date : 2024-06-01 Epub Date: 2024-05-12 DOI:10.1080/14779072.2024.2354255
Taehwan Park, Monica Hwang
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引用次数: 0

摘要

背景:最近获得 FDA 批准的心血管疾病(CVD)药物需要在上市后进行严格的监测。本研究的目的是利用大型药物警戒数据库评估这些药物的安全性:我们利用FDA不良事件报告系统(FAERS)分析了2014年至2021年期间批准的17种药物的不良事件(AE)报告。通过估计报告几率比(ROR)及其95%置信区间,进行了描述性分析和比例失调分析:在43,664,773份不良反应报告中,97,702份(0.22%)与新批准的心血管疾病药物有关。非格列奈和依维那单抗未报告任何不良反应。比例失调分析结果显示,在使用沙库比特利/缬沙坦的患者中存在急性肾损伤(ROR = 8.24,95% CI:6.05-11.22)、心力衰竭(ROR = 4.80,95% CI:3.82-6.05)和低血压(ROR = 3.98,95% CI:3.44-4.61)的潜在风险。此外,还发现伊伐布雷定与心动过速(ROR = 11.94,95% CI:8.35-17.08)、感觉异常(ROR = 4.40,95% CI:2.70-7.18)和头晕(ROR = 2.56,95% CI:1.68-3.90)有关:本研究发现了与近期批准的心血管疾病药物相关的特定安全性问题。结论:本研究发现了与最近批准的心血管疾病药物有关的特定安全性问题,需要进一步研究以了解这些发现的潜在机制和临床意义。
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Safety of cardiovascular disease drugs approved between 2014 and 2021 in the US: a pharmacovigilance analysis.

Background: Recently FDA-approved drugs for cardiovascular disease (CVD) require robust post-marketing surveillance. The objective of this study was to assess their safety using a large pharmacovigilance database.

Research design and methods: We analyzed adverse event (AE) reports for 17 drugs approved from 2014 to 2021, utilizing the FDA Adverse Event Reporting System (FAERS). Descriptive and disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and its 95% confidence interval.

Results: Among the 43,664,773 AE reports 97,702 (0.22%) were related to newly approved CVD drugs. No AEs were reported for finerenone and evinacumab. The results from the disproportionality analyses revealed potential risks of acute kidney injury (ROR = 8.24, 95% CI: 6.05-11.22), cardiac failure (ROR = 4.80, 95% CI: 3.82-6.05), and hypotension (ROR = 3.98, 95% CI: 3.44-4.61) among sacubitril/valsartan users. Additionally, ivabradine was found to be associated with tachycardia (ROR = 11.94, 95% CI: 8.35-17.08), abnormal feeling (ROR = 4.40, 95% CI: 2.70-7.18), and dizziness (ROR = 2.56, 95% CI: 1.68-3.90).

Conclusions: This study identified specific safety concerns related to recently approved CVD drugs. Further research is required to understand the underlying mechanisms and clinical implications of these findings.

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来源期刊
Expert Review of Cardiovascular Therapy
Expert Review of Cardiovascular Therapy CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
3.70
自引率
0.00%
发文量
82
期刊介绍: Expert Review of Cardiovascular Therapy (ISSN 1477-9072) provides expert reviews on the clinical applications of new medicines, therapeutic agents and diagnostics in cardiovascular disease. Coverage includes drug therapy, heart disease, vascular disorders, hypertension, cholesterol in cardiovascular disease, heart disease, stroke, heart failure and cardiovascular surgery. The Expert Review format is unique. Each review provides a complete overview of current thinking in a key area of research or clinical practice.
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