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      Current status of 5α-reductase inhibitors in the management of lower urinary tract symptoms and BPH

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          Abstract

          Purpose

          Benign prostatic hyperplasia (BPH) is a progressive disease that is commonly associated with bothersome lower urinary tract symptoms (LUTS) and might result in complications, such as acute urinary retention and BPH-related surgery. Therefore, the goals of therapy for BPH are not only to improve LUTS in terms of symptoms and urinary flow, but also to identify those patients at a risk of unfavorable disease progression and to optimize their management. This article reviews the current status of therapy with 5α-reductase inhibitors (5ARIs), namely fiasteride and dutasteride, for men with LUTS and BPH.

          Method

          Data from key randomized controlled trials (Oxford level 1b) on the use of 5ARIs are analyzed.

          Results

          The efficacy of 5ARIs either as monotherapy or in combination with α 1-adrenoceptor antagonists in the management of LUTS and the impact of monotherapy and combined therapy on BPH progression are discussed. Further promises, including the withdrawal of the α-blocker from the combined medical treatment and the potential clinical implications from the use of 5ARIs for prostate cancer chemoprevention in patients receiving 5ARIs for symptomatic BPH are highlighted.

          Conclusions

          Current evidence shows that 5ARIs are effective in treating LUTS and preventing disease progression and represent a recommended option in treatment guidelines for men who have moderate to severe LUTS and enlarged prostates.

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          Most cited references31

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          The influence of finasteride on the development of prostate cancer.

          Ian Thompson, Phyllis J. Goodman, Catherine M Tangen … (2003)
          Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5alpha-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer. In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study. Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleason grade 7, 8, 9, or 10 were more common in the finasteride group (280 of 757 tumors [37.0 percent], or 6.4 percent of the 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], P<0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo. Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer. Copyright 2003 Massachusetts Medical Society
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            The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

            John McConnell, Claus Roehrborn, Oliver M Bautista … (2003)
            Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy. Copyright 2003 Massachusetts Medical Society
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              The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group.

              M Lieber, John A M Taylor, Elizabeth J. McConnell … (1998)
              Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, is not known. In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men. During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001). Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the risk of surgery and acute urinary retention.
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                Author and article information

                Contributors
                : +30-6944-626086 , sgravas2002@yahoo.com
                Journal
                Journal ID (nlm-ta): World J Urol
                Title: World Journal of Urology
                Publisher: Springer-Verlag (Berlin/Heidelberg )
                ISSN (Print): 0724-4983
                ISSN (Electronic): 1433-8726
                Publication date (Electronic): 3 December 2009
                Publication date PMC-release: 3 December 2009
                Publication date (Print): February 2010
                Volume: 28
                Issue: 1
                Pages: 9-15
                Affiliations
                [1 ]Department of Urology, University of Thessaly, 6-8, Feidiou Street, 41221 Larissa, Greece
                [2 ]Department of Urology, Hannover Medical School, Hannover, Germany
                [3 ]Department of Urology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
                Article
                Publisher ID: 493
                DOI: 10.1007/s00345-009-0493-y
                PMC ID: 2809314
                PubMed ID: 19956956
                SO-VID: fd2fedee-49ee-4aff-b9da-58ca8b608546
                Copyright © © The Author(s) 2009
                History
                Date received : 16 October 2009
                Date accepted : 17 November 2009
                Categories
                Subject: Topic Paper
                Custom metadata
                issue-copyright-statement © Springer-Verlag 2010

                ScienceOpen disciplines: Urology
                Keywords: finasteride,benign prostatic hyperplasia,combination treatment,disease progression,chemoprevention,dutasteride,5α-reductase inhibitors,lower urinary tract symptoms
                Data availability:
                ScienceOpen disciplines: Urology
                Keywords: finasteride, benign prostatic hyperplasia, combination treatment, disease progression, chemoprevention, dutasteride, 5α-reductase inhibitors, lower urinary tract symptoms

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