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The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

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  • Authors+Show Affiliations

    ,

    University of Texas Southwestern Medical Center, Dallas, TX 75390-9110, USA.

    , , , , , , , , , , , , , , , , , , , , , , , , ,

    Source

    The New England journal of medicine 349:25 2003 Dec 18 pg 2387-98

    MeSH

    5-alpha Reductase Inhibitors
    Adrenergic alpha-Antagonists
    Analysis of Variance
    Disease Progression
    Double-Blind Method
    Doxazosin
    Drug Therapy, Combination
    Enzyme Inhibitors
    Finasteride
    Humans
    Male
    Middle Aged
    Prostatic Hyperplasia
    Severity of Illness Index

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    14681504

    Citation

    McConnell, John D., 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, vol. 349, no. 25, 2003, pp. 2387-98.
    McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349(25):2387-98.
    McConnell, J. D., Roehrborn, C. G., Bautista, O. M., Andriole, G. L., Dixon, C. M., Kusek, J. W., ... Smith, J. A. (2003). The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. The New England Journal of Medicine, 349(25), pp. 2387-98.
    McConnell JD, et al. The Long-term Effect of Doxazosin, Finasteride, and Combination Therapy On the Clinical Progression of Benign Prostatic Hyperplasia. N Engl J Med. 2003 Dec 18;349(25):2387-98. PubMed PMID: 14681504.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. AU - McConnell,John D, AU - Roehrborn,Claus G, AU - Bautista,Oliver M, AU - Andriole,Gerald L,Jr AU - Dixon,Christopher M, AU - Kusek,John W, AU - Lepor,Herbert, AU - McVary,Kevin T, AU - Nyberg,Leroy M,Jr AU - Clarke,Harry S, AU - Crawford,E David, AU - Diokno,Ananias, AU - Foley,John P, AU - Foster,Harris E, AU - Jacobs,Stephen C, AU - Kaplan,Steven A, AU - Kreder,Karl J, AU - Lieber,Michael M, AU - Lucia,M Scott, AU - Miller,Gary J, AU - Menon,Mani, AU - Milam,Douglas F, AU - Ramsdell,Joe W, AU - Schenkman,Noah S, AU - Slawin,Kevin M, AU - Smith,Joseph A, AU - ,, PY - 2003/12/19/pubmed PY - 2003/12/24/medline PY - 2003/12/19/entrez SP - 2387 EP - 98 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 349 IS - 25 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/14681504/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa030656?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -