PDF(Pubmed)
Abstract：
UNASSIGNED: As a novel drug formulation, antibody drug conjugates (ADCs) are widely used in various types of cancer. However, clinically, there is a lack of attention to the CVD produced by them, as well as a lack of research on the real-world situation. Using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, to ensure its clinical safety application, we analyzed post-marketing data on antitumor ADCs to identify risk factors and drugs associated with the risk of cardiovascular events.
UNASSIGNED: We used OpenVigil 2.1 to conduct a database query for adverse events (AEs) reported to the FAERS database between the time the drug was launched and the second quarter of 2023. Cardiovascular adverse events (AEs) were grouped into fourteen narrow categories using the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs), and the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) for reporting the association between different drugs and cardiovascular disease (CVD) risk were calculated.
UNASSIGNED: In the FAERS database, 1863 AEs associated with CVD we studied were identified in patients receiving ADC therapy. Most reports came from people aged ≥65, but a significant number of cases were found to be unknown. The number of patients with antibody-drug conjugates (ADCs)-related CVD cases aged <18 years, 18-64 years, and≥ 65 years was 52 (2.79%), 586 (31.45%), and 613 (32.90%), respectively. The proportion of female patients (834, 44.77%) was higher than that of male patients (752, 40.37%). Death (770 reports), disability (9 reports), Hospitalization initial or prolonged (407 reports), and life-threatening reactions (187 reports). Of the 770 deaths reported, 103 (31.7%) were associated with brentuximab vedotin, 10 (24.4%) with sacituzumab govitecan, 22 (19.3%) with enfortumab vedotin, and 35 (34.7%) with trastuzumab emtansine.49 (41.2%) cases were associated with polatuzumab vedotin, 62 (29%) with trastuzumab deruxtecan, 423 (54.3%) with gemtuzumab ozogamicin, and 66 (38.8%) with inotuzumab ozogamicin. In a disproportionate number of SMQS, cardiac failure (n = 277) and embolic and thrombotic events, venous (n = 446) were the most frequently reported CVD-related AEs in ADCs.
UNASSIGNED: By mining the FAERS database, we provided relevant information on the association between ADC use and cardiovascular-associated AEs. ADCs were associated with increased cardiovascular toxicity, deserving distinct monitoring and appropriate management. Further research is needed to confirm these findings and assess causality.
UNASSIGNED: We used OpenVigil 2.1 to conduct a database query for adverse events (AEs) reported to the FAERS database between the time the drug was launched and the second quarter of 2023. Cardiovascular adverse events (AEs) were grouped into fourteen narrow categories using the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs), and the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) for reporting the association between different drugs and cardiovascular disease (CVD) risk were calculated.
UNASSIGNED: In the FAERS database, 1863 AEs associated with CVD we studied were identified in patients receiving ADC therapy. Most reports came from people aged ≥65, but a significant number of cases were found to be unknown. The number of patients with antibody-drug conjugates (ADCs)-related CVD cases aged <18 years, 18-64 years, and≥ 65 years was 52 (2.79%), 586 (31.45%), and 613 (32.90%), respectively. The proportion of female patients (834, 44.77%) was higher than that of male patients (752, 40.37%). Death (770 reports), disability (9 reports), Hospitalization initial or prolonged (407 reports), and life-threatening reactions (187 reports). Of the 770 deaths reported, 103 (31.7%) were associated with brentuximab vedotin, 10 (24.4%) with sacituzumab govitecan, 22 (19.3%) with enfortumab vedotin, and 35 (34.7%) with trastuzumab emtansine.49 (41.2%) cases were associated with polatuzumab vedotin, 62 (29%) with trastuzumab deruxtecan, 423 (54.3%) with gemtuzumab ozogamicin, and 66 (38.8%) with inotuzumab ozogamicin. In a disproportionate number of SMQS, cardiac failure (n = 277) and embolic and thrombotic events, venous (n = 446) were the most frequently reported CVD-related AEs in ADCs.
UNASSIGNED: By mining the FAERS database, we provided relevant information on the association between ADC use and cardiovascular-associated AEs. ADCs were associated with increased cardiovascular toxicity, deserving distinct monitoring and appropriate management. Further research is needed to confirm these findings and assess causality.
摘要：
■作为一种新型药物制剂，抗体药物缀合物(ADC)广泛用于各种类型的癌症。然而,临床上,对它们产生的CVD缺乏关注，以及缺乏对现实世界情况的研究。使用食品和药物管理局不良事件报告系统（FAERS）数据库，为了确保其临床安全应用，我们分析了上市后抗肿瘤ADC的数据,以确定与心血管事件风险相关的危险因素和药物.
■我们使用OpenVigil2.1对从药物上市到2023年第二季度之间报告给FAERS数据库的不良事件（AE）进行了数据库查询。心血管不良事件（AE）被分为十四个窄类别使用标准化医学词典监管活动（MedDRA）查询（SMQ），并计算了报告不同药物与心血管疾病(CVD)风险之间关联的报告比值比(ROR)和比例报告比(PRR).
■在FAERS数据库中，在接受ADC治疗的患者中发现了1863例与CVD相关的AE。大多数报告来自年龄≥65岁的人，但发现大量病例未知。年龄<18岁的抗体-药物偶联物（ADC）相关CVD病例的患者数量，18-64岁,≥65岁为52岁（2.79%），586（31.45%），和613（32.90%），分别。女性患者比例(834,44.77%)高于男性患者比例(752,40.37%)。死亡（770份报告），残疾(9份报告)，初次或长期住院（407份报告），和危及生命的反应（187份报告）。在报告的770例死亡中，103（31.7％）与本妥昔单抗vedotin相关，10（24.4%）与sacituzumabgovitecan，22（19.3%）与enfortumabvedotin，和35（34.7％）使用曲妥珠单抗依坦素。49（41.2％）例与polatuzumabvedotin相关，62（29%）使用曲妥珠单抗deruxtecan，423（54.3%）与吉妥珠单抗奥佐大霉素，66（38.8%）与伊托珠单抗奥佐大霉素。在不成比例的SMQS中，心力衰竭（n=277）和栓塞和血栓事件，静脉(n=446)是ADC中最常见的CVD相关AE.
■通过挖掘FAERS数据库，我们提供了ADC使用与心血管相关AE之间关联的相关信息.ADC与心血管毒性增加有关，值得独特的监控和适当的管理。需要进一步的研究来证实这些发现并评估因果关系。
■我们使用OpenVigil2.1对从药物上市到2023年第二季度之间报告给FAERS数据库的不良事件（AE）进行了数据库查询。心血管不良事件（AE）被分为十四个窄类别使用标准化医学词典监管活动（MedDRA）查询（SMQ），并计算了报告不同药物与心血管疾病(CVD)风险之间关联的报告比值比(ROR)和比例报告比(PRR).
■在FAERS数据库中，在接受ADC治疗的患者中发现了1863例与CVD相关的AE。大多数报告来自年龄≥65岁的人，但发现大量病例未知。年龄<18岁的抗体-药物偶联物（ADC）相关CVD病例的患者数量，18-64岁,≥65岁为52岁（2.79%），586（31.45%），和613（32.90%），分别。女性患者比例(834,44.77%)高于男性患者比例(752,40.37%)。死亡（770份报告），残疾(9份报告)，初次或长期住院（407份报告），和危及生命的反应（187份报告）。在报告的770例死亡中，103（31.7％）与本妥昔单抗vedotin相关，10（24.4%）与sacituzumabgovitecan，22（19.3%）与enfortumabvedotin，和35（34.7％）使用曲妥珠单抗依坦素。49（41.2％）例与polatuzumabvedotin相关，62（29%）使用曲妥珠单抗deruxtecan，423（54.3%）与吉妥珠单抗奥佐大霉素，66（38.8%）与伊托珠单抗奥佐大霉素。在不成比例的SMQS中，心力衰竭（n=277）和栓塞和血栓事件，静脉(n=446)是ADC中最常见的CVD相关AE.
■通过挖掘FAERS数据库，我们提供了ADC使用与心血管相关AE之间关联的相关信息.ADC与心血管毒性增加有关，值得独特的监控和适当的管理。需要进一步的研究来证实这些发现并评估因果关系。
