Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis

Neil M. Schultz (), David F. Penson, Samuel Wilson, Yan Song, Hongbo Yang, Krishnan Ramaswamy and Benjamin Lowentritt
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Neil M. Schultz: Astellas Pharma Inc.
David F. Penson: Vanderbilt University Medical Center
Samuel Wilson: Astellas Pharma Inc.
Yan Song: Analysis Group, Inc.
Hongbo Yang: Analysis Group, Inc.
Krishnan Ramaswamy: Pfizer Inc.
Benjamin Lowentritt: Chesapeake Urology

Drug Safety, 2020, vol. 43, issue 1, No 4, 23-33

Abstract: Abstract Introduction Corticosteroids are a mainstay treatment for castration-resistant prostate cancer (CRPC). Although corticosteroids have been associated with adverse events, long-term outcomes related to their sustained use have not been assessed in men with CRPC. Objective This study evaluated the impact of cumulative corticosteroid exposure on the risk of developing specific adverse events in men with CRPC. Methods Data were obtained from administrative claims databases. Adult chemotherapy-naïve men who initiated CRPC treatment following surgical or medical castration were selected. Patients were grouped into four cohorts based on cumulative corticosteroid dose: no exposure, low exposure ( 2.0 g). Time to each adverse event was assessed using Kaplan–Meier analyses and time-dependent Cox proportional hazard models, adjusting for baseline characteristics. Results Overall, 9425 patients were included (no exposure, N = 6765; low exposure, N = 1660; medium exposure, N = 655; high exposure, N = 345). The mean age was 71–76 years across cohorts. During the study period, cumulative corticosteroid exposure was associated with a significantly higher risk of developing an infection [high vs. no exposure, adjusted hazard ratio (HR) 2.55; 95% confidence interval (CI) 2.27–2.85; p

Date: 2020
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DOI: 10.1007/s40264-019-00867-6

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