Bernd J Schmitz-Dräger, Ekkehardt Bismarck, Thomas Ebert, Roland Starlinger, Kerstin Dienes, Bertram Ottillinger, Peter J Goebell, Stephan Mühlich, Natalya Benderska-Söder, Jutta Bergler-Klein, Oliver W Hakenberg
{"title":"基于GnRH激动剂的雄激素剥夺治疗在现实环境中的心血管安全性：一项前瞻性队列研究（LEAN）的结果。","authors":"Bernd J Schmitz-Dräger, Ekkehardt Bismarck, Thomas Ebert, Roland Starlinger, Kerstin Dienes, Bertram Ottillinger, Peter J Goebell, Stephan Mühlich, Natalya Benderska-Söder, Jutta Bergler-Klein, Oliver W Hakenberg","doi":"10.1159/000543985","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 52 deaths reported in patients with MACEs, 12 were related to a CV event and 20 were related to disease progression.</p><p><strong>Conclusion: </strong>In a large European patient cohort, leuprorelin-based ADT demonstrated an acceptable safety profile, with a low incidence of CV events.</p>","PeriodicalId":23414,"journal":{"name":"Urologia Internationalis","volume":" ","pages":"1-9"},"PeriodicalIF":1.5000,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cardiovascular Safety of GnRH Agonist-Based Androgen Deprivation Therapy in a Real-World Setting: Results from a Prospective Cohort Study (LEAN).\",\"authors\":\"Bernd J Schmitz-Dräger, Ekkehardt Bismarck, Thomas Ebert, Roland Starlinger, Kerstin Dienes, Bertram Ottillinger, Peter J Goebell, Stephan Mühlich, Natalya Benderska-Söder, Jutta Bergler-Klein, Oliver W Hakenberg\",\"doi\":\"10.1159/000543985\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 52 deaths reported in patients with MACEs, 12 were related to a CV event and 20 were related to disease progression.</p><p><strong>Conclusion: </strong>In a large European patient cohort, leuprorelin-based ADT demonstrated an acceptable safety profile, with a low incidence of CV events.</p>\",\"PeriodicalId\":23414,\"journal\":{\"name\":\"Urologia Internationalis\",\"volume\":\" \",\"pages\":\"1-9\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-02-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Urologia Internationalis\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000543985\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Urologia Internationalis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000543985","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
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 52 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.
期刊介绍：
Concise but fully substantiated international reports of clinically oriented research into science and current management of urogenital disorders form the nucleus of original as well as basic research papers. These are supplemented by up-to-date reviews by international experts on the state-of-the-art of key topics of clinical urological practice. Essential topics receiving regular coverage include the introduction of new techniques and instrumentation as well as the evaluation of new functional tests and diagnostic methods. Special attention is given to advances in surgical techniques and clinical oncology. The regular publication of selected case reports represents the great variation in urological disease and illustrates treatment solutions in singular cases.
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