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Original Research

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Patterns of finasteride and dutasteride use in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial cohort: effects of socio-demographic factors and a black box warning

  • Jarrett A. Johnson1,2,*,
  • Paul F. Pinsky3
  • Howard L. Parnes4
  • Damali N. Martin2

1Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute, Rockville, MD 20850, USA

2Genomic Epidemiology Branch, Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD 20850, USA

3Early Detection Research Branch, Division of Cancer Prevention, National Cancer Institute, Rockville, MD 20850, USA

4Prostate and Urologic Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, Rockville, MD 20850, USA

DOI: 10.31083/j.jomh1801019 Vol.18,Issue 1,January 2022 pp.1-8

Submitted: 21 May 2021 Accepted: 24 August 2021

Published: 31 January 2022

*Corresponding Author(s): Jarrett A. Johnson E-mail:


Background: Five-alpha reductase inhibitors (5-ARIs), specifically finasteride and dutasteride, have been shown to significantly reduce prostate cancer incidence. However, these agents were also associated with a significant increase in the detection of high-grade prostate cancer leading to an FDA black box warning in 2011. Little is known about the effect of this warning on the subsequent use of these 5-ARIs. The purpose of this analysis was to assess use patterns of finasteride and dutasteride before and after the black box warning. Methods: This cohort study evaluated men enrolled in the Prostate, Lung, Colorectal and Ovarian (PLCO) screening trial who had ≥12 months of Medicare Part D coverage from 2008 to 2015, and had not been diagnosed with prostate cancer through 2007. Socio-demographic factors and benign prostatic hyperplasia (BPH) status were ascertained from follow-up questionnaires, while medication use was ascertained from linkage to Medicare Part D claims data. Results: Of 14,833 eligible men, 88.7% identified as non-Hispanic white, 1.7% as African-American, 5.2% as Asian/Pacific Islander and 1.7% as Hispanic. The median age was 72 years; 41.8% reported a BPH diagnosis. Only 13.6% and 4% of the population took finasteride or dutasteride, respectively, at any time from 2008 to 2015. During this period, finasteride use significantly increased from 3.6% to 9.7% and was highest among men with BPH; dutasteride use remained low and decreased from 2.8% to 1.9%. Conclusions: Finasteride use significantly increased after the FDA’s 2011 black box warning, while dutasteride use remained low and steady throughout the study period.


Benign prostatic hyperplasia; 5-ARIs; Black box warning; Socio-demographic factors

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Jarrett A. Johnson,Paul F. Pinsky,Howard L. Parnes,Damali N. Martin. Patterns of finasteride and dutasteride use in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial cohort: effects of socio-demographic factors and a black box warning. Journal of Men's Health. 2022. 18(1);1-8.


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