Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer
Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer
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DOI：
10.1093/jnci/djac081
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发表时间：
2022-05-20
影响因子：
10.3
通讯作者：
Shahinian, Vahakn B.
中科院分区：
文献类型：
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作者：
Lai, Lillian Y.;Oerline, Mary K.;Shahinian, Vahakn B.
背景阿比拉特龙和苯扎鲁胺是治疗晚期前列腺癌的最常用的口服药物。为了了解它们在真实世界环境中的安全性，我们研究了阿比特龙或苯扎鲁胺的使用与治疗期间代谢或心血管不良事件风险之间的关联。方法在2010-2017年国家医疗保险申报的20%样本中，确定患有晚期前列腺癌并使用阿比特龙或苯扎鲁胺的男性。主要的综合结果是发生重大的代谢或心血管不良事件，定义为与糖尿病、高血压或心血管疾病的初步诊断相关的急诊室就诊或住院。次要的综合结果是发生轻微的代谢或心血管不良事件，定义为与上述疾病的初步诊断相关的门诊就诊。使用COX回归分别评估阿比特龙和苯扎鲁胺的风险。所有的统计检验都是双侧的。结果与未接受阿比特龙治疗的男性相比，接受阿比特龙治疗的男性发生重大复合不良事件(风险比[HR]=1.77，95%可信区间[CI]=1.53至2.05；P<；001)和轻微复合不良事件(HR=1.24，95%CI=1.05至1.47；P=.01)的风险均增加。与未服用苯扎鲁胺的男性相比，接受苯扎鲁胺治疗的男性发生重大综合不良事件的风险增加(HR=1.22，95%CI=1.01至1.48；P=0.04)，但未出现轻微的复合不良事件(HR=1.04，95%CI=0.83至1.30；P=.75)。结论通过以团队为基础的方法对服用阿比特龙或苯扎鲁胺的男性进行仔细的监测和管理是至关重要的。
Background Abiraterone and enzalutamide are the most common oral agents for the treatment of men with advanced prostate cancer. To understand their safety profiles in real-world settings, we examined the association between the use of abiraterone or enzalutamide and the risk of metabolic or cardiovascular adverse events while on treatment. Methods Men with advanced prostate cancer and their use of abiraterone or enzalutamide were identified in a 20% sample of the 2010-2017 national Medicare claims. The primary composite outcome was the occurrence of a major metabolic or cardiovascular adverse event, defined as an emergency room visit or hospitalization associated with a primary diagnosis of diabetes, hypertension, or cardiovascular disease. The secondary composite outcome was the occurrence of a minor metabolic or cardiovascular adverse event, defined as an outpatient visit associated with a primary diagnosis of the aforementioned conditions. Risks were assessed separately for abiraterone and enzalutamide using Cox regression. All statistical tests were 2-sided. Results Compared with men not receiving abiraterone, men receiving abiraterone were at increased risk of both a major composite adverse event (hazard ratio [HR] = 1.77, 95% confidence interval [CI] = 1.53 to 2.05; P < .001) and a minor composite adverse event (HR = 1.24, 95% CI = 1.05 to 1.47; P = .01). Compared with men not receiving enzalutamide, men receiving enzalutamide were at an increased risk of a major composite adverse event (HR = 1.22, 95% CI = 1.01 to 1.48; P = .04) but not a minor composite adverse event (HR = 1.04, 95% CI = 0.83 to 1.30; P = .75). Conclusion Careful monitoring and management of men on abiraterone or enzalutamide through team-based approaches are critical.