Combined Drug Therapy Best for BPH

The study appeared in the December 18, 2003, issue of The New England Journal of Medicine.

Researchers tested whether the drug finasteride (Proscar), doxazosin (Cardura), or a combination of the two could prevent BHP progression and the need for surgery. The study involved more than 3,000 men with BPH, who were treated for an average of 4.5 years. Every three months, vital signs, urinary symptoms, urinary flow, side effects, and medication usage were checked, while digital rectal exams, serum prostate-specific antigen (PSA), and urine were checked yearly. Together, finasteride and doxazosin reduced the overall risk of BPH progression by 66%, compared to placebo, and also provided the greatest symptom relief and improvement in urinary flow. Alone, doxazosin reduced overall risk of progression by 39% and finasteride alone by 34%. The combination and finasteride alone also reduced the risk of invasive therapy by 67% and 64%, respectively.

The combination therapy was especially effective in men at highest risk for BPH progression, those with prostates larger than 40 ml or serum PSAs above 4 ng/ml. BPH progressed in only 5% of men on the two drugs, in 10% on doxazosin, in 10% on finasteride, and in 17% of men on placebo. Because of side effects, 18% of men on combination therapy, 24% of men on finasteride, and 27% of men on doxazosin stopped treatments early. The most common side effects included dysfunction in men on finasteride and dizziness and tiredness in men treated with doxazosin.

"The combination therapy offers dramatically greater and longer-lasting relief from symptoms and, over time, the finasteride shrinks the prostate and actually prevents growth so that fewer men at highest risk for progressive disease need surgery,” said lead author John D. McDonnell, M.D., professor of urology at the University of Texas Southwestern Medical Center (Dallas, USA).




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U. Texas Southwestern Med. Center