Supplementary Material for: ​​​Cardiovascular Safety of GnRH Agonist-Based Androgen Deprivation Therapy in a Real-World Setting: Results from a Prospective Cohort Study (LEAN)

Introduction: LEAN is a prospective, multicenter, noninterventional, German cohort study in patients with locally advanced and metastatic hormone-sensitive prostate cancer (PC). This analysis explores the efficacy and safety of leuprorelin in patients with PC and an indication for androgen deprivation therapy (ADT) in routine practice. Methods: Safety assessment focused on the incidence of major adverse cardiovascular (CV) events (MACEs; a composite of all-cause death, myocardial infarction, or stroke) over the 12-month study period. Patients initiating ADT before enrollment were excluded from the analysis. Results: Of the 1,372 patients included, MACEs occurred in 57 (4.2%) patients, and in 18/532 (3.4%) versus 39/840 (4.6%) patients without and with a pre-existing CV comorbidity, respectively (p=0.264). Of the 57 MACEs, 17 were CV events and 20 were considered PC related events; in 20 patients, events were classed as ‘other’ or the context remained unknown. Only one MACE, nonserious arrhythmia, was considered drug related by the urologist. Of the 51 deaths reported in patients with MACEs, 12 were related to a CV event and 20 were related to disease progression. Conclusion: In a large European patient cohort, leuprorelin-based ADT demonstrated an acceptable safety profile, with a low incidence of CV events.引言：LEAN是一项针对局部晚期及转移性激素敏感性前列腺癌（prostate cancer, PC）患者的前瞻性、多中心、非干预性德国队列研究。本分析旨在探究常规临床实践中，前列腺癌患者应用亮丙瑞林（leuprorelin）且符合雄激素剥夺治疗（androgen deprivation therapy, ADT）适应证时的疗效与安全性。方法：安全性评估聚焦于12个月研究周期内主要不良心血管（cardiovascular, CV）事件（major adverse cardiovascular events, MACEs，复合终点涵盖全因死亡、心肌梗死或卒中）的发生率。入组前已启动雄激素剥夺治疗的患者被排除本次分析。结果：纳入的1372例患者中，共57例（4.2%）发生主要不良心血管事件；其中无基础心血管合并症患者的发生率为3.4%（18/532），有基础心血管合并症患者的发生率为4.6%（39/840），组间差异无统计学意义（p=0.264）。在57例主要不良心血管事件中，17例为心血管事件，20例判定为前列腺癌相关事件，剩余20例被归类为“其他”事件或病因不明。仅1例主要不良心血管事件（非严重性心律失常）被泌尿科医师判定为与药物相关。在发生主要不良心血管事件的患者中，共计报告51例死亡，其中12例与心血管事件相关，20例与疾病进展相关。结论：在大型欧洲患者队列中，基于亮丙瑞林的雄激素剥夺治疗展现出可接受的安全性特征，心血管事件发生率较低。