Goryachok Maksym, Nicklawsky Andrew, Ahmad Hiba, Geiger Christopher, Kim Simon, Flaig Thomas W
University of Colorado School of Medicine, Aurora, CO.
Department of Biostatistics and Bioinformatics, University of Colorado School of Medicine, Aurora, CO.
JCO Oncol Pract. 2025 May;21(5):637-646. doi: 10.1200/OP-24-00472. Epub 2024 Oct 21.
Abiraterone use for prostate cancer can cause mineralocorticoid excess syndrome (MES; eg, hypertension and hypokalemia). Prednisone mitigates these effects; however, the optimal dose level is unclear. This study examines MES effects from abiraterone with 5 mg of prednisone once daily versus 5 mg twice daily.
Data for 1,410 abiraterone-treated patients from 2011 to 2022 were identified from a large academic/community hospital system. Three hundred and fifty-three patients were excluded for missing medication data and use of an alternative steroid; 1,057 patients remained (5 mg once daily, n = 550, 5 mg twice daily, n = 507). Prednisone dose was treated as a time-varying covariate. Hypokalemia and hypertension incidence over 24 weeks after abiraterone initiation was analyzed via Cox proportional hazard models using Common Terminology Criteria for Adverse Events (v5.0) grading via direct clinical measurements and International Classification of Diseases (ICD)-10 code outcomes.
Patients receiving 5 mg of prednisone twice daily had a statistically significant decrease in cumulative hazard for experiencing at least one MES event (hypertension and/or hypokalemia) via direct clinical measurement (hazard ratio [HR], 0.79 [CI, 0.68 to 0.91]; = .002) and by ICD-10 code (HR, 0.65 [CI, 0.54 to 0.79]; < .001) analysis. This finding was durable with individual end point analysis of hypertension and hypokalemia. There were no changes to BMI or hyperglycemia (>140 mg/dL) between the cohorts.
This retrospective analysis shows a decrease in risk for the development of at least one episode of hypertension or hypokalemia with abiraterone using 5 mg twice-daily prednisone in the study population. Assessments of metabolic impacts (BMI, hyperglycemia) did not show differences with prednisone dosing. These findings may merit consideration when determining an optimal prednisone dosing regimen.
阿比特龙用于前列腺癌治疗时可引发盐皮质激素过多综合征（MES；如高血压和低钾血症）。泼尼松可减轻这些影响；然而，最佳剂量水平尚不清楚。本研究比较了阿比特龙联合每日一次5毫克泼尼松与每日两次5毫克泼尼松对MES的影响。
从一个大型学术/社区医院系统中识别出2011年至2022年接受阿比特龙治疗的1410例患者的数据。353例患者因缺少用药数据和使用替代类固醇而被排除；剩余1057例患者（每日一次5毫克，n = 550；每日两次5毫克，n = 507）。泼尼松剂量被视为随时间变化的协变量。在阿比特龙开始治疗后的24周内，通过Cox比例风险模型分析低钾血症和高血压的发生率，使用不良事件通用术语标准（第5.0版）进行分级，通过直接临床测量和国际疾病分类（ICD）-10编码结果进行分析。
通过直接临床测量，每日两次接受5毫克泼尼松治疗的患者经历至少一次MES事件（高血压和/或低钾血症）的累积风险有统计学显著降低（风险比[HR]，0.79[置信区间，0.68至0.91]；P = 0.002），通过ICD-10编码分析也有降低（HR，0.65[置信区间，0.54至0.79]；P < 0.001）。这一发现对于高血压和低钾血症的个体终点分析是持久的。两组之间的体重指数或高血糖（>140毫克/分升）没有变化。
这项回顾性分析表明，在研究人群中，使用每日两次5毫克泼尼松的阿比特龙方案可降低至少发生一次高血压或低钾血症发作的风险。对代谢影响（体重指数、高血糖）的评估未显示泼尼松给药方式存在差异。在确定最佳泼尼松给药方案时，这些发现可能值得考虑。
