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A review of the clinical efficacy and safety of 5alpha-reductase inhibitors for the enlarged prostate.

Abstract

BACKGROUND

Enlargement of the prostate is common among aging men, with an incidence of 90% by the age of 85 years. It is a progressive condition, with growth in prostate size accompanied by lower urinary tract symptoms that can result in long-term complications (eg, acute urinary retention [AUR], need for enlarged prostate-related surgery). Current pharmacologic treatment options include alpha-blockers (alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (5ARIs) (finasteride and dutasteride).

OBJECTIVES

This article reviews the natural history of enlarged prostate and the data supporting management of this condition with alpha-blocker and 5ARI therapy, either as monotherapy or combination therapy, for symptomatic relief and a reduction in long-term disease progression.

METHODS

Pertinent English-language articles were identified through a search of MEDLINE (1966-week 2, May 2006) using such search terms as 5alpha-reductase inhibitor, alpha-blocker, benign prostatic hyperplasia, dutasteride, efficacy, enlarged prostate, finasteride, and safety.

RESULTS

Clinical trials of alpha-blockers in men with enlarged prostate have reported improvements in total symptom scores of 10% to 20% compared with placebo; however, these agents were not shown to reduce the risk of long-term complications or disease progression. Studies of the 5ARIs have reported significant reductions compared with placebo in the relative risk for AUR and enlarged prostate-related surgery, slowing of disease progression, and relief of symptoms. In studies of dutasteride, improvements in symptom scores were greater after 4 years of therapy compared with 2 years (-6.4 vs -4.3 points, respectively) and flow rates were better (2.6 vs 2.3 mL/sec). Six-year data for finasteride showed maintenance of the decreased risk for AUR and enlarged prostate-related surgery. Use of combination therapy with an alpha-blocker and a 5ARI may be of benefit in patients who require immediate relief of symptoms, with discontinuation of the alpha-blocker after several months of therapy. 5ARIs were generally well tolerated, with sexual dysfunction the most frequently reported adverse effect, although in only a small proportion of men (1%-8%).

CONCLUSIONS

The use of 5ARI therapy is a rational approach to symptom management and prevention of long-term negative outcomes in men with enlarged prostates.V 3.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. mnaslund@smail.umaryland.edu

    Source

    Clinical therapeutics 29:1 2007 Jan pg 17-25

    MeSH

    Adrenergic alpha-Antagonists
    Aged
    Aged, 80 and over
    Azasteroids
    Drug Therapy, Combination
    Dutasteride
    Enzyme Inhibitors
    Finasteride
    Humans
    Male
    Middle Aged
    Prostatic Hyperplasia
    Randomized Controlled Trials as Topic

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't
    Review

    Language

    eng

    PubMed ID

    17379044

    Citation

    Naslund, Michael J., and Martin Miner. "A Review of the Clinical Efficacy and Safety of 5alpha-reductase Inhibitors for the Enlarged Prostate." Clinical Therapeutics, vol. 29, no. 1, 2007, pp. 17-25.
    Naslund MJ, Miner M. A review of the clinical efficacy and safety of 5alpha-reductase inhibitors for the enlarged prostate. Clin Ther. 2007;29(1):17-25.
    Naslund, M. J., & Miner, M. (2007). A review of the clinical efficacy and safety of 5alpha-reductase inhibitors for the enlarged prostate. Clinical Therapeutics, 29(1), pp. 17-25.
    Naslund MJ, Miner M. A Review of the Clinical Efficacy and Safety of 5alpha-reductase Inhibitors for the Enlarged Prostate. Clin Ther. 2007;29(1):17-25. PubMed PMID: 17379044.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A review of the clinical efficacy and safety of 5alpha-reductase inhibitors for the enlarged prostate. AU - Naslund,Michael J, AU - Miner,Martin, PY - 2006/12/01/accepted PY - 2007/3/24/pubmed PY - 2007/8/8/medline PY - 2007/3/24/entrez SP - 17 EP - 25 JF - Clinical therapeutics JO - Clin Ther VL - 29 IS - 1 N2 - BACKGROUND: Enlargement of the prostate is common among aging men, with an incidence of 90% by the age of 85 years. It is a progressive condition, with growth in prostate size accompanied by lower urinary tract symptoms that can result in long-term complications (eg, acute urinary retention [AUR], need for enlarged prostate-related surgery). Current pharmacologic treatment options include alpha-blockers (alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (5ARIs) (finasteride and dutasteride). OBJECTIVES: This article reviews the natural history of enlarged prostate and the data supporting management of this condition with alpha-blocker and 5ARI therapy, either as monotherapy or combination therapy, for symptomatic relief and a reduction in long-term disease progression. METHODS: Pertinent English-language articles were identified through a search of MEDLINE (1966-week 2, May 2006) using such search terms as 5alpha-reductase inhibitor, alpha-blocker, benign prostatic hyperplasia, dutasteride, efficacy, enlarged prostate, finasteride, and safety. RESULTS: Clinical trials of alpha-blockers in men with enlarged prostate have reported improvements in total symptom scores of 10% to 20% compared with placebo; however, these agents were not shown to reduce the risk of long-term complications or disease progression. Studies of the 5ARIs have reported significant reductions compared with placebo in the relative risk for AUR and enlarged prostate-related surgery, slowing of disease progression, and relief of symptoms. In studies of dutasteride, improvements in symptom scores were greater after 4 years of therapy compared with 2 years (-6.4 vs -4.3 points, respectively) and flow rates were better (2.6 vs 2.3 mL/sec). Six-year data for finasteride showed maintenance of the decreased risk for AUR and enlarged prostate-related surgery. Use of combination therapy with an alpha-blocker and a 5ARI may be of benefit in patients who require immediate relief of symptoms, with discontinuation of the alpha-blocker after several months of therapy. 5ARIs were generally well tolerated, with sexual dysfunction the most frequently reported adverse effect, although in only a small proportion of men (1%-8%). CONCLUSIONS: The use of 5ARI therapy is a rational approach to symptom management and prevention of long-term negative outcomes in men with enlarged prostates.V 3. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/17379044/A_review_of_the_clinical_efficacy_and_safety_of_5alpha_reductase_inhibitors_for_the_enlarged_prostate_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(07)00032-X DB - PRIME DP - Unbound Medicine ER -