Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
摘要：
■最近FDA批准的心血管疾病（CVD）药物需要强有力的上市后监测。这项研究的目的是使用大型药物警戒数据库评估其安全性。
■我们利用FDA不良事件报告系统（FAERS）分析了2014年至2021年批准的17种药物的不良事件（AE）报告。通过估计报告比值比（ROR）及其95％置信区间进行描述性和不相称性分析。
■在43,664,773份AE报告中，97,702份（0.22%）与新批准的CVD药物有关。没有报告finetenone和evinacumab的不良事件。不成比例分析的结果揭示了急性肾损伤的潜在风险（ROR=8.24，95％CI：6.05-11.22），心力衰竭（ROR=4.80，95%CI：3.82-6.05），沙库必曲/缬沙坦使用者低血压（ROR=3.98，95%CI：3.44-4.61）。此外,发现伊伐布雷定与心动过速有关（ROR=11.94，95％CI：8.35-17.08），感觉异常（ROR=4.40，95%CI：2.70-7.18），头晕（ROR=2.56，95%CI：1.68-3.90）。
■本研究确定了与最近批准的CVD药物相关的特定安全问题。需要进一步的研究来了解这些发现的潜在机制和临床意义。
■我们利用FDA不良事件报告系统（FAERS）分析了2014年至2021年批准的17种药物的不良事件（AE）报告。通过估计报告比值比（ROR）及其95％置信区间进行描述性和不相称性分析。
■在43,664,773份AE报告中，97,702份（0.22%）与新批准的CVD药物有关。没有报告finetenone和evinacumab的不良事件。不成比例分析的结果揭示了急性肾损伤的潜在风险（ROR=8.24，95％CI：6.05-11.22），心力衰竭（ROR=4.80，95%CI：3.82-6.05），沙库必曲/缬沙坦使用者低血压（ROR=3.98，95%CI：3.44-4.61）。此外,发现伊伐布雷定与心动过速有关（ROR=11.94，95％CI：8.35-17.08），感觉异常（ROR=4.40，95%CI：2.70-7.18），头晕（ROR=2.56，95%CI：1.68-3.90）。
■本研究确定了与最近批准的CVD药物相关的特定安全问题。需要进一步的研究来了解这些发现的潜在机制和临床意义。
