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
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
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
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.
 American Cancer Society. Key statistics for prostate cancer. 2021. Available at: https://www.cancer.org/cancer/prostate-can cer/about/key-statistics.html (Accessed: 19 February 2021).
 American Cancer Society. Cancer Facts & Figures 2021. At-lanta: American Cancer Society. 2021.
 Filson CP, Wei JT, Hollingsworth JM. Trends in Medical Man-agement of Men with Lower Urinary Tract Symptoms Sugges-tive of Benign Prostatic Hyperplasia. Urology. 2013; 82: 1386–1393.
 Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, et al. The Influence of Finasteride on the Development of Prostate Cancer. New England Journal of Medicine. 2003; 349: 215–224.
 Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Mar-berger M, Montorsi F, et al. Effect of Dutasteride on the Risk of Prostate Cancer. New England Journal of Medicine. 2010; 362: 1192–1202.
 USFDA. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of more serious form of prostate cancer. 2011. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-d rug-safety-communication-5-alpha-reductase-inhibitors-5-a ris-may-increase-risk-more-serious (Accessed: 10 January 2020).
 USFDA. Guidance for industry: warnings and precau-tions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products–content and format [PDF]. 2011. Available at: https://www.fda.gov/files/drugs/published/Warnings-and-Pre cautions--Contraindications--and-Boxed-Warning-Sections-of- Labeling-for-Human-Prescription-Drug-and-Biological-Pro ducts-%E2%80%94-Content-and-Format.pdf (Accessed: 10 January 2020).
 Wagner AK, Chan KA, Dashevsky I, Raebel MA, Andrade SE, Lafata JE, et al. FDA drug prescribing warnings: is the black box half empty or half full? Pharmacoepidemiology and Drug Safety. 2006; 15: 369–386.
 MURPHY S, ROBERTS R. “Black box” 101: how the Food and Drug Administration evaluates, communicates, and man-ages drug benefit/risk. Journal of Allergy and Clinical Immunol-ogy. 2006; 117: 34–39.
 Kjærulff TM, Ersbøll AK, Green A, Emneus M, Pukkala E, Bolin K, et al. Patterns of finasteride use in the male popula-tions of four Nordic countries: a cross-national drug utilization study. Scandinavian Journal of Urology. 2016; 50: 220–227.
 Prorok PC, Andriole GL, Bresalier RS, Buys SS, Chia D, Craw-ford ED, et al. Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Controlled Clinical Trials. 2000; 21: 273S–309S.
 Andriole GL, Levin DL, Crawford ED, Gelmann EP, Pinsky PF, Chia D, et al. Prostate Cancer Screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: findings from the initial screening round of a randomized trial. Jour-nal of the National Cancer Institute. 2005; 97: 433–438.
 Zito PM, Bistas KG, Syed K. Finasteride. In: StatPearls [Inter-net]. Treasure Island (FL): StatPearls Publishing. 2021. Avail-able at: https://www.ncbi.nlm.nih.gov/books/NBK513329/(Accessed: 13 April 2021).
 McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. The New England Journal of Medicine. 2003; 349: 2387–2398.
 McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, et al. Update on AUA guideline on the manage-ment of benign prostatic hyperplasia. The Journal of Urology. 2011; 185: 1793–1803.
 Dhingra N, Bhagwat D. Benign prostatic hyperplasia: an overview of existing treatment. Indian Journal of Pharmacology. 2011; 43: 6–12.
 Roehrborn C. Benign Prostatic Hyperplasia: Etiology, Patho-physiology, Epidemiology, and Natural History. In McDougal WS, Wein AJ, Kavoussi LR, Novick AC, Patin AW, Peters CA, et al. (eds.) Campbell-Walsh Urology. Elsevier: Ámsterdam. 2012.
 Roehrborn CG. Benign prostatic hyperplasia: an overview. Re-views in Urology. 2005; 7: S3–S14.
 Preston MA, Wilson KM, Markt SC, Ge R, Morash C, Stampfer MJ, et al. 5α-Reductase inhibitors and risk of high-grade or lethal prostate cancer. JAMA Internal Medicine. 2014; 174: 1301–1307.
 Kearns JT, Faino AV, Schenk JM, Newcomb LF, Brooks JD, Carroll PR, et al. Continued 5α-Reductase Inhibitor Use after Prostate Cancer Diagnosis and the Risk of Reclassification and Adverse Pathological Outcomes in the PASS. Journal of Urol-ogy. 2018; 201: 106–111.
 Thompson IM, Chi C, Ankerst DP, Goodman PJ, Tangen CM, Lippman SM, et al. Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. Journal of the National Can-cer Institute. 2006; 98: 1128–1133.
 Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Parnes HL, Lippman SM, et al. Finasteride improves the sensitivity of digi-tal rectal examination for prostate cancer detection. The Journal of Urology. 2007; 177: 1749–1752.
 Lucia MS, Epstein JI, Goodman PJ, Darke AK, Reuter VE, Civantos F, et al. Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. Journal of the National Cancer Institute. 2007; 99: 1375–1383.
 Thompson IM, Goodman PJ, Tangen CM, Parnes HL, Minasian LM, Godley PA, et al. Long-term survival of participants in the prostate cancer prevention trial. The New England Journal of Medicine. 2013; 369: 603–610.
 Goodman PJ, Tangen CM, Darke AK, Lucia MS, Ford LG, Mi-nasian LM, et al. Long-Term Effects of Finasteride on Prostate Cancer Mortality. The New England Journal of Medicine. 2019; 380: 393–394.
 Liss MA, Thompson IM. Prostate cancer prevention with 5-alpha reductase inhibitors: concepts and controversies. Current Opinion in Urology. 2018; 28: 42–45.
 Deng T, Lin X, Duan X, He Z, Zhao Z, Zeng G. Prostate cancer patients can benefit from 5-alpha-reductase inhibitor treatment: a meta-analysis. PeerJ.2020; 8: e9282.
 VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Combination Alpha-Blocker and Finasteride Therapy for BPH: Recommen-dations for VA Primary Care Providers. 2004. Available at: https://www.pbm.va.gov/apps/VANationalFormulary/GetF ile.aspx (Accessed: 25 September 2019).
 Hamilton RJ, Kahwati LC, Kinsinger LS. Knowledge and Use of Finasteride for the Prevention of Prostate Cancer. Cancer Epi-demiology Biomarkers & Prevention. 2010; 19: 2164–2171.
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