与GnRH激动剂和GnRH拮抗剂相关的心血管不良事件:来自Eudra-Vigilance和美国食品和药物管理局数据库条目的实时数据分析。
Cardiovascular adverse events-related to GnRH agonists and GnRH antagonists: analysis of real-life data from Eudra-Vigilance and Food and Drug Administration databases entries.
发表日期:2023 Jan 14
作者:
Antonio Cicione, Antonio Nacchia, Alessandro Guercio, Carmen Gravina, Antonio Franco, Maria Chiara Grimaldi, Giorgia Tema, Riccardo Lombardo, Andrea Tubaro, Cosimo De Nunzio
来源:
PROSTATE CANCER AND PROSTATIC DISEASES
摘要:
GnRH 激动剂和 GnRH 拮抗剂是治疗前列腺癌(PCa)荷尔蒙疗法(HT)的两个主要支柱。这些药物因有心血管(CV)不良事件(AEs)的风险增加而备受关注。我们的研究目的是基于 Eudra-Vigilance(EV)和美国食品药品监督管理局(FDA)报道的 AE 比较 GnRH 激动剂和 GnRH 拮抗剂相关的真实数据。我们查询了 EV 和 FDA 数据库,记录了 Degarelix、Buserelin、Goserelin、Leuprorelin 和 Triptorelin 直到 2021 年 9 月的 CV AEs 数量。记录了特定的 CV AEs,并按年龄和严重程度进行了数据分析。汇总相对风险(PRR)用于比较药物之间的数据。Degarelix 的 CV 事件报告为 315/5128(6%),Buserelin 为 55/628(9%),Goserelin 为 843/12,145(7%),Leuprorelin 为 3395/71,160(5%),Triptorelin 为 214/4969(5%)。就特定的 CV 疾病而言,与 GnRH 激动剂相比,Degarelix 的高血压风险更低(PRR 0.60(95% CI 0.37-0.98),p = 0.04),心肌梗塞风险更低(PRR 0.05(95% CI 0.01-0.39),p <0.01),而凝血风险则相对较低(PRR 0.14(0.02-1.07),p = 0.06)。总体而言,年轻患者(<65 岁)的 CV AEs 风险极低。在 90-96% 的情况下,副作用被归类为严重。致命的 AEs 在 CV AEs 中占 5-20%,在总 AEs 中占 0.2-1%。真实数据与登记研究一致,关于与 HT 相关的副作用。真实数据表明,在与 GnRH 拮抗剂相比较时,GnRH 激动剂与更高的 CV AEs 相关联。临床医生在为患有 CV 共病的患者开处 HT 时,应考虑这些数据。©2023年。作者(S),在 Springer Nature Limited 独家许可下。
GnRH agonists and GnRH antagonists are two of the mainstays of hormonal therapy (HT) for prostate cancer (PCa). These drugs are at increased risk of cardiovascular (CV) adverse events (AEs). Aim of our study was to compare real-life data on AEs associated with GnRH agonists and GnRH antagonists based on Eudra-Vigilance (EV) and Food and Drug Administration (FDA) reported AEs.EV and FDA databases were queried and the number of CV adverse events (AEs) for degarelix, buserelin, goserelin, leuprorelin, triptorelin until September 2021 were recorded. Specific CV AEs were recorded and data were analyzed per age and severity. pooled relative risk (PRR) was used to compare data between drugs.CV events were reported in 315/5128 (6%) for Degarelix, in 55/628 for Buserelin (9%), in 843/12,145 (7%) for Goserelin, in 3395/71,160 (5%) for Leuprorelin and in 214/4969 (5%) for Triptorelin. In terms of specific CV disorders, Degarelix presented lower risk of hypertension (PRR 0.60 (95% CI 0.37-0.98), p = 0.04), of myocardial infarction (PRR 0.05 (95% CI 0.01-0.39), p < 0.01) and thrombosis (PRR 0.14 (0.02-1.07), p = 0.06) when compared to GnRH agonists. Overall, younger patients (<65 years) presented a very low risk of CV AEs. Side effects were classified as serious in 90-96% of the cases. Fatal AEs were 5-20% over the CV AEs and 0.2-1% over the total AEs.Real-life data are consistent with registry studies regarding side effects related to HT. Real-life data suggest GnRH agonists are associated with higher CV AEs when compared to GnRH antagonists. Clinicians should consider these data when prescribing HT especially in patients with CV comorbidities.© 2023. The Author(s), under exclusive licence to Springer Nature Limited.