Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature


https://doi.org/10.4081/aiua.2019.4.205
Vol. 91 No. 4 (2019)
Published: January 13, 2020
Benign prostatic hyperplasia, 5 alpha-reductase inhibitor, Finasteride, Side effects
Abstract Views: 3112
PDF: 1425
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Authors

  • Gian Maria Busetto
    gianmaria.busetto@uniroma1.it
    Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome, Italy.
  • Francesco Del Giudice Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome, Italy.
  • Daniele D'Agostino Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.
  • Daniele Romagnoli Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.
  • Andrea Minervini Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy.
  • Bernardo Rocco Department of Urology, University of Modena and Reggio Emilia, Modena, Italy.
  • Alessandro Antonelli Department of Urology, Azienda Ospedaliera Universitaria Integrata (A.O.U.I.), Verona, Italy.
  • Antonio Celia Department of Urology, San Bassiano Hospital, Bassano Del Grappa, Italy.
  • Riccardo Schiavina Department of Urology, University of Bologna, Bologna, Italy.
  • Luca Cindolo Department of Urology, Villa Stuart Hospital, Rome, Italy.
  • Benjamin I. Chung Department of Urology, Stanford Medical Center, Palo Alto, CA, United States.
  • Jae Heon Kim Department of Urology, Soonchunhyang University Seoul Hospital, Soon Chun Hyang University College of Medicine, Seoul, Korea, Republic of.
  • Martina Maggi Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome, Italy.
  • Alessandro Sciarra Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome, Italy.
  • Ettore De Berardinis Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome, Italy.
  • Angelo Porreca Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy.

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated.
Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH.
Materials and methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs).
Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients.
Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.


Busetto, G. M., Del Giudice, F., D’Agostino, D., Romagnoli, D., Minervini, A., Rocco, B., Antonelli, A., Celia, A., Schiavina, R., Cindolo, L., Chung, B. I., Kim, J. H., Maggi, M., Sciarra, A., De Berardinis, E., & Porreca, A. (2020). Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature. Archivio Italiano Di Urologia E Andrologia, 91(4), 205–210. https://doi.org/10.4081/aiua.2019.4.205

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