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Cited by 107Urinary Bladder and Prostate ResearchProstate Cancer Diagnosis and TreatmentProstate Cancer Treatment and Research

Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia

Lowe, Franklin C, McConnell, John D, Hudson, Perry B, Romas, Nicholas A, Boake, Rex, Lieber, Michael, Elhilali, Mostafa, Geller, Jack +12 more·2003·Urology
DOI 10.1016/s0090-4295(02)02548-7
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Abstract

Objectives To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.Methods The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo.Results After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension.Conclusions Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.

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  • Proof-of-concept for inhibition of intracrine pathways has been established by aromatase inhibition in breast cancer and 5α-reductase inhibition in prostate hyperplasia.

    “The proof-of-concept has been established by aromatase inhibition in breast cancer and 5α-reductase inhibition in prostate hyperplasia (Chumsri et al., 2011, Lowe et al., 2003, McConnell et al., 1998).”

    From Intracrine androgen biosynthesis, metabolism and action revisited (2018) · cites this paper as Lowe et al., 2003

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Authors
Lowe, F. C., McConnell, J. D., Hudson, P. B., Romas, N. A., Boake, R., Lieber, M., Elhilali, M., Geller, J., Imperto-McGinely, J., Andriole, G. L., Bruskewitz, R. C., Walsh, P. C., Bartsch, G., Nacey, J. N., Shah, S., Pappas, F., Ko, A., Cook, T., Stoner, E., & Waldstreicher, J.
Affiliations
  • St. Luke's-Roosevelt Hospital Center (US)
  • The University of Texas Southwestern Medical Center (US)
  • Veterans Health Administration (US)
  • University of Alberta (CA)
  • Mayo Clinic (US)
  • Royal Victoria Hospital (CA)
  • AntiCancer (United States) (US)
  • Washington University in St. Louis (US)
  • University of Wisconsin–Madison (US)
  • Johns Hopkins University (US)
  • Innsbruck Medical University (AT)
  • Wellington Hospital (NZ)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Corresponding author
Lowe, Franklin C
ORCID
Venue
Urology
Publisher
Elsevier BV
Published
2003-04
Volume
61
Issue
4
Pages
791-796
ISSN
0090-4295 (ISSN-L)
DOI
10.1016/s0090-4295(02)02548-7
OpenAlex
W1993339135
Cited by
107
References
28
Citations by year
2026: 1 · 2025: 1 · 2023: 1 · 2022: 1 · 2020: 6 · 2019: 6 · 2018: 4 · 2017: 3 · 2016: 4 · 2015: 6 · 2014: 5 · 2013: 4 · 2012: 3
FWCI
7.97
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Urology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
Keywords
finasteride, benign prostatic hyperplasia, long-term safety, long-term efficacy, open-label extension, AUA symptom score, prostate volume, urinary flow rate, 5-alpha reductase inhibitors
MeSH terms
Enzyme Inhibitors, Follow-Up Studies, Humans, Erectile Dysfunction, Longitudinal Studies, Male, Middle Aged, Placebos, Prostate, Prostatic Hyperplasia, Treatment Outcome, Finasteride, Sexual Dysfunctions, Psychological, 5-alpha Reductase Inhibitors

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