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Previous Volume 349:2387-2398 December 18, 2003 Number 25 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Vaughan, E. D. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Benign prostatic hyperplasia is commonly treated with alpha-adrenergic–receptor antagonists (alpha-blockers) or 5-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.

Source Information

From the University of Texas Southwestern Medical Center, Dallas (J.D.M., C.G.R.); George Washington University, Rockville, Md. (O.M.B.); Washington University, St. Louis (G.L.A.); New York University, New York (C.M.D., H.L.); National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md. (J.W.K., L.M.N.); Northwestern University, Chicago (K.T.M.); Emory University, Atlanta (H.S.C.); University of Colorado Health Sciences Center, Denver (E.D.C., M.S.L., G.J.M.); William Beaumont Hospital, Royal Oak, Mich. (A.D.); Brooke Army Medical Center, Fort Sam Houston, Texas (J.P.F.); Yale University, New Haven, Conn. (H.E.F.); University of Maryland, Baltimore (S.C.J.); New York Presbyterian Hospital, New York (S.A.K.); University of Iowa, Iowa City (K.J.K.); Mayo Clinic, Rochester, Minn. (M.M.L.); Henry Ford Hospital, Detroit (M.M.); Vanderbilt University, Nashville (D.F.M., J.A.S.); University of California at San Diego, La Jolla (J.W.R.); Walter Reed Army Medical Center, Washington, D.C. (N.S.S.); and Baylor College of Medicine, Houston (K.M.S.).

Address reprint requests to Dr. Roehrborn at the University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., J8-130, Dallas, TX 75390-9110, or at claus.roehrborn{at}utsouthwestern.edu.

Full Text of this Article

Related Letters:

Finasteride in Benign Prostatic Hyperplasia
Wysowski D. K., Farinas E., Verhamme K. M.C., Bosch R. J.L.H., Sturkenboom M. C.J.M., Roehrborn C. G., the Medical Therapy of Prostatic Symptoms (MTOPS) Research Group
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N Engl J Med 2004; 350:1359-1361, Mar 25, 2004. Correspondence

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