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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):2387-98NEJM

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.

Authors+Show Affiliations

University of Texas Southwestern Medical Center, Dallas, TX 75390-9110, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 - http://www.nejm.org/doi/full/10.1056/NEJMoa030656?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -