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Treatment of BPH: Are Two Drugs Better Than One?

Finasteride plus doxazosin improved BPH symptom scores more than either drug alone.

The 2 most commonly prescribed drug classes for treating symptomatic benign prostatic hyperplasia (BPH) work by different mechanisms: -blockers reduce smooth-muscle tone in the bladder neck and prostate, and 5-reductase inhibitors reduce prostate volume. To assess the effectiveness of combination therapy, researchers conducted this double-blind, randomized trial in which 3047 men with at least moderately symptomatic BPH received the -blocker doxazosin (Cardura and generics), the 5-reductase inhibitor finasteride (Proscar), both drugs, or double placebo. The NIH and makers of the 2 brand-name drugs supported the study.

The primary endpoint, overall clinical progression, was defined as increased symptoms, acute urinary retention, renal insufficiency, recurrent urinary infection, or incontinence. The 4-year incidence of progression was 17% with placebo, 10% with each monotherapy, and 5% with combination therapy. Differences between combination therapy and monotherapies and between monotherapies and placebo were highly significant. Improved symptom scores accounted for most of the benefit. In addition, rates of urinary retention and invasive treatment (e.g., prostatectomy) were lower with finasteride alone and with combination therapy (but not with doxazosin alone) than with placebo. Four patients, all in the 2 finasteride groups, were diagnosed with breast cancer.

Comment: In this trial, both finasteride and doxazosin delayed the progression of symptomatic BPH. Doxazosin was particularly useful for reducing daily symptoms, and finasteride was especially effective in minimizing need for invasive interventions. However, combination therapy, given for several years, was more effective than either drug alone. Because an excess of breast cancer has not been reported in other large trials of finasteride, the authors believe that the breast cancer cases were chance occurrences.

— Allan S. Brett, MD

Published in Journal Watch General Medicine January 13, 2004

Citation(s):

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; 349:2387-98.

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