Axel S. Merseburger, Eugen Dornstauder, Carsten-Henning Ohlmann, Armen Aprikian, Sophia Junker, Philipp Hahn, Andrew Chilelli, Matthias Stoelzel, Alexis Serikoff, Stefan G. Spitzer
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AA (2012) and ENZA (2014) are widely used for mCRPC in Germany.</p><h3>Methods</h3><p>This retrospective study used data of chemotherapy-naïve patients with mCRPC on ENZA or AA (2012–2020) from two German claims databases (AOK PLUS and GWQ ServicePlus). The primary endpoint was time to first CV event (CV-related hospitalization) analyzed via a meta-analysis of Cox proportional hazard models of propensity score-matched (PSM) intention-to-treat cohorts. Other endpoints were baseline characteristics, CV event rate, number of CV events per patient, and OS.</p><h3>Results</h3><p>Of 2240 patients in the total study population (ENZA, 828; AA, 1412), 796 PSM patients were included in each group. ENZA patients were older and had a higher prevalence of some comorbidities, but without meaningful differences after PSM. Further, 386 patients had ≥ 1 CV event (ENZA, 172; AA, 214). ENZA was associated with a significantly lower risk of CV events (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.57–0.86, <i>p</i> = 0.001, <i>I</i><sup>2</sup> = 0.0%), CV event rate (0.17 vs 0.23 per person-year; event rate ratio 0.75, 95% CI 0.61–0.92, <i>p</i> = 0.006; <i>I</i><sup>2</sup> = 38.0%), fewer recurrent CV events (HR 0.77, 95% CI 0.61–0.96, <i>p</i> = 0.024; <i>I</i><sup>2</sup> = 0.0%), and prolonged OS (HR 0.79, 95% CI 0.71–0.89, <i>p</i> < 0.001) than AA.</p><h3>Conclusions</h3><p>The unmatched ENZA cohort had higher average age and more comorbidities than the AA cohort, but no meaningful differences were noted after PSM. 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Spitzer\",\"doi\":\"10.1007/s12325-025-03132-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Recent real-world studies compared effectiveness and safety of enzalutamide (ENZA) and abiraterone acetate (AA) for metastatic castration-resistant prostate cancer (mCRPC). The growing evidence needs further substantiation with long-term data. This study, the first to use German data, investigated cardiovascular (CV) event risk and overall survival (OS) in patients initiating ENZA or AA. AA (2012) and ENZA (2014) are widely used for mCRPC in Germany.</p><h3>Methods</h3><p>This retrospective study used data of chemotherapy-naïve patients with mCRPC on ENZA or AA (2012–2020) from two German claims databases (AOK PLUS and GWQ ServicePlus). The primary endpoint was time to first CV event (CV-related hospitalization) analyzed via a meta-analysis of Cox proportional hazard models of propensity score-matched (PSM) intention-to-treat cohorts. Other endpoints were baseline characteristics, CV event rate, number of CV events per patient, and OS.</p><h3>Results</h3><p>Of 2240 patients in the total study population (ENZA, 828; AA, 1412), 796 PSM patients were included in each group. ENZA patients were older and had a higher prevalence of some comorbidities, but without meaningful differences after PSM. Further, 386 patients had ≥ 1 CV event (ENZA, 172; AA, 214). 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引用次数: 0
摘要
最近的真实世界研究比较了恩杂鲁胺（ENZA）和醋酸阿比特龙（AA）治疗转移性去势抵抗性前列腺癌（mCRPC）的有效性和安全性。越来越多的证据需要用长期数据进一步证实。这项研究首次使用了德国的数据，调查了初始化ENZA或AA患者的心血管（CV）事件风险和总生存期（OS）。德国mCRPC广泛使用AA（2012）和ENZA（2014）。方法：本回顾性研究使用来自德国两个索赔数据库（AOK PLUS和GWQ ServicePlus）的chemotherapy-naïve患ENZA或AA的mCRPC患者（2012-2020年）的数据。主要终点是通过倾向评分匹配（PSM）意向治疗队列的Cox比例风险模型进行荟萃分析，分析首次CV事件（CV相关住院）的时间。其他终点包括基线特征、心血管事件发生率、每位患者的心血管事件数和OS。结果：总研究人群中2240例患者(ENZA， 828例；AA, 1412)，每组796例PSM患者。ENZA患者年龄较大，一些合并症的患病率较高，但PSM后无显著差异。此外，386例患者有≥1例CV事件(ENZA， 172例；AA, 214)。ENZA与CV事件风险显著降低相关（风险比[HR] 0.70, 95%可信区间[CI] 0.57-0.86, p = 0.001, I2 = 0.0%）， CV事件发生率(0.17 vs 0.23 /人/年；事件发生率比0.75,95% CI 0.61-0.92, p = 0.006；I2 = 38.0%)，更少的复发CV事件(HR 0.77, 95% CI 0.61-0.96, p = 0.024；I2 = 0.0%)和延长的OS （HR 0.79, 95% CI 0.71-0.89, p）。结论：未匹配的ENZA队列比AA队列平均年龄高，合并症多，但PSM后无显著差异。ENZA与显著降低的CV事件风险和改善的OS相关。
Cardiovascular Risks and Survival with Abiraterone vs Enzalutamide in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer in Germany: AVENGER Study
Introduction
Recent real-world studies compared effectiveness and safety of enzalutamide (ENZA) and abiraterone acetate (AA) for metastatic castration-resistant prostate cancer (mCRPC). The growing evidence needs further substantiation with long-term data. This study, the first to use German data, investigated cardiovascular (CV) event risk and overall survival (OS) in patients initiating ENZA or AA. AA (2012) and ENZA (2014) are widely used for mCRPC in Germany.
Methods
This retrospective study used data of chemotherapy-naïve patients with mCRPC on ENZA or AA (2012–2020) from two German claims databases (AOK PLUS and GWQ ServicePlus). The primary endpoint was time to first CV event (CV-related hospitalization) analyzed via a meta-analysis of Cox proportional hazard models of propensity score-matched (PSM) intention-to-treat cohorts. Other endpoints were baseline characteristics, CV event rate, number of CV events per patient, and OS.
Results
Of 2240 patients in the total study population (ENZA, 828; AA, 1412), 796 PSM patients were included in each group. ENZA patients were older and had a higher prevalence of some comorbidities, but without meaningful differences after PSM. Further, 386 patients had ≥ 1 CV event (ENZA, 172; AA, 214). ENZA was associated with a significantly lower risk of CV events (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.57–0.86, p = 0.001, I2 = 0.0%), CV event rate (0.17 vs 0.23 per person-year; event rate ratio 0.75, 95% CI 0.61–0.92, p = 0.006; I2 = 38.0%), fewer recurrent CV events (HR 0.77, 95% CI 0.61–0.96, p = 0.024; I2 = 0.0%), and prolonged OS (HR 0.79, 95% CI 0.71–0.89, p < 0.001) than AA.
Conclusions
The unmatched ENZA cohort had higher average age and more comorbidities than the AA cohort, but no meaningful differences were noted after PSM. ENZA was associated with a significantly lower risk of CV events and improved OS.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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