COVID-19 Impact on Adverse Event Reports of Cardiovascular Drugs

IF 2.3 4区医学 Q1 MEDICINE, GENERAL & INTERNAL

Journal of the National Medical Association Pub Date : 2025-09-01 DOI:10.1016/j.jnma.2025.08.014

Xiaodong Feng, Alicia Feng, David Tran, Uyen Le PhD

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引用次数: 0

Abstract

Introduction

During the COVID-19 pandemic, adverse event (AE) reports were significantly affected. Since Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) interact with the ACE pathway, the entry target for SARS-CoV-2, we hypothesized they might show distinct AE trends compared to other cardiovascular drugs. This study examines COVID-19 cases and AE reporting for these drugs from 2016 to 2023.

Methods

A retrospective analysis was conducted using publicly available data from the CDC COVID Data Tracker and the FDA Adverse Event Reporting System (FAERS). AE trends for most common 29 cardiovascular drugs across seven major classes were analyzed, including ACEIs, ARBs, renin inhibitors, loop diuretics, beta-blockers, and calcium channel blockers (CCB). The study compared AE reporting trends for ACEIs and ARBs during and after the COVID-19 pandemic against other cardiovascular drugs to determine whether their observed AE decline was linked to COVID-19 treatment interactions, altered prescribing behaviors, or reporting shifts.

Results

The analysis revealed a steady increase in AE reports across cardiovascular drug classes from 2016 to 2019, with ACEIs peaking at 9.5K AEs and ARBs at 8.1K AEs in 2019. However, unlike other cardiovascular drugs, ACEIs and ARBs sharply declined from 2019 to 2023, with ACEIs decreasing by 3.5K AEs (-36.8%) and ARBs by 2.7K AEs (-30.9%). This suggests a potential shift in reduction in the severity of adverse reactions reported. In contrast, CCBs and Diuretics/Loop maintained stable or increasing trends, with CCBs rising by 10.6% from 6.6K to 7.3K AEs and Diuretics/Loop showing minimal fluctuation (+1.6%). Beta-blockers exhibited a moderate decrease (-21.6%), while Renin Inhibitors and Aldosterone Antagonists remained low and stable throughout this period. In addition, the top three drugs Ramipril, Lisinopril, and Valsartan experienced significant declines in reported AEs. Ramipril AEs dropped from 4.4K in 2019 to 2.5K in 2023 (-43.2%), Lisinopril decreased by 52% (4.2K to 2K), and Valsartan fell by 54.8% (3.1K to 1.4K). The steepest declines occurred between 2019 and 2021, during the COVID-19 pandemic, suggesting changes in AE reporting behavior.

In addition, the Davies test on ACEI data yielded a statistically significant change in slope (p = 0.01732) with an optimal breakpoint near 2019. Before 2019, AEs increased at about 1,221 reports per year, while after the breakpoint, the slope reversed by –2,306.9, resulting in a post-break trend of roughly –1,085.9 reports per year. These findings demonstrate a significant reversal from a strong upward trend to a marked decline.

Conclusion

The findings show that ACEIs and ARBs experienced significant declines in AE reports from 2019 to 2023, especially between 2019 and 2021, while other cardiovascular drugs like CCBs remained stable or increased. This trend may reflect favorable interactions with COVID-19 treatments that mitigated adverse effects. Further research is needed to determine whether these trends represent actual reductions in adverse reactions, changes in prescribing practices, or shifts in AE reporting during the pandemic.

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COVID-19对心血管药物不良事件报告的影响

在COVID-19大流行期间，不良事件（AE）报告受到显著影响。由于血管紧张素转换酶抑制剂（ACEIs）和血管紧张素受体阻滞剂（ARBs）与ACE途径（SARS-CoV-2的进入靶点）相互作用，我们假设与其他心血管药物相比，它们可能表现出不同的AE趋势。本研究调查了2016年至2023年这些药物的COVID-19病例和AE报告。方法使用CDC COVID数据跟踪器和FDA不良事件报告系统（FAERS）的公开数据进行回顾性分析。分析了7大类最常见的29种心血管药物的AE趋势，包括ACEIs、arb、肾素抑制剂、环利尿剂、受体阻滞剂和钙通道阻滞剂（CCB）。该研究比较了acei和arb在COVID-19大流行期间和之后与其他心血管药物的AE报告趋势，以确定他们观察到的AE下降是否与COVID-19治疗相互作用、处方行为改变或报告变化有关。结果分析显示，2016年至2019年，心血管药物类别的AE报告稳步增加，acei峰值为9.5K AE， arb峰值为8.1K AE。然而，与其他心血管药物不同，acei和arb在2019年至2023年期间急剧下降，acei下降3.5K ae (-36.8%)， arb下降2.7K ae（-30.9%）。这表明不良反应严重程度的降低有可能发生变化。相比之下，ccb和利尿剂/环路保持稳定或上升趋势，ccb从6.6K上升到7.3K ae，上升10.6%，利尿剂/环路波动最小（+1.6%）。-受体阻滞剂表现出中度下降（-21.6%），而肾素抑制剂和醛固酮拮抗剂在此期间保持低水平和稳定。此外，排名前三的药物雷米普利、赖诺普利和缬沙坦报告的ae显著下降。雷米普利ae从2019年的4.4K下降到2023年的2.5K(-43.2%)，赖诺普利下降52% (4.2K降至2K)，缬沙坦下降54.8% （3.1K降至1.4K）。在2019年至2021年COVID-19大流行期间，下降幅度最大，这表明AE报告行为发生了变化。此外，对ACEI数据的Davies检验得出斜率变化具有统计学意义（p = 0.01732），最佳断点在2019年附近。在2019年之前，ae每年增加约1,221份报告，而在断点之后，斜率逆转了-2,306.9份，导致断点后趋势约为每年-1,085.9份报告。这些发现表明，从强劲的上升趋势到明显的下降趋势发生了重大逆转。结论研究结果显示，2019 - 2023年，尤其是2019 - 2021年，ACEIs和arb在AE报告中呈明显下降趋势，而ccb等其他心血管药物则保持稳定或增加。这一趋势可能反映了与COVID-19治疗的良好相互作用，减轻了不良反应。需要进一步研究以确定这些趋势是否代表不良反应的实际减少、处方做法的改变或大流行期间不良反应报告的转变。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the National Medical Association 医学-医学：内科

CiteScore

4.80

自引率

3.00%

发文量

139

审稿时长

98 days

期刊介绍： Journal of the National Medical Association, the official journal of the National Medical Association, is a peer-reviewed publication whose purpose is to address medical care disparities of persons of African descent. The Journal of the National Medical Association is focused on specialized clinical research activities related to the health problems of African Americans and other minority groups. Special emphasis is placed on the application of medical science to improve the healthcare of underserved populations both in the United States and abroad. The Journal has the following objectives: (1) to expand the base of original peer-reviewed literature and the quality of that research on the topic of minority health; (2) to provide greater dissemination of this research; (3) to offer appropriate and timely recognition of the significant contributions of physicians who serve these populations; and (4) to promote engagement by member and non-member physicians in the overall goals and objectives of the National Medical Association.