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Combination Therapy Significantly Delays Progression of Benign Prostatic Hyperplasia

Results May Affect Treatment for Half of American Men 60 and Older

New York, NY (Jan 5, 2004)

For men who suffer from enlargement of the prostate, also called benign prostatic hyperplasia (BPH), combining two classes of drugs reduces the risk of significant worsening of symptoms and other BPH complications by 66 percent, according to a multi-center study authored by a physician-scientist at NewYork-Presbyterian Hospital/Columbia University Medical Center. The study results, published in the December 18 New England Journal of Medicine, may affect treatment for men with BPH including half of all men 60 and older in the United States.

The five-year study provides the first scientific evidence that combining alpha-blocking doxazosin with the drug finasteride is significantly more effective than using either treatment alone. The clinical trial involved more than 3,000 men and 20 major medical centers across the United States and is the largest study of its kind ever conducted.

Use of finasteride alone or the combination therapy significantly reduced the risk of acute urinary retention and the need for surgical intervention. A surprising finding of the study was that the alpha-blocker doxazosin reduced symptom progression.

Men with BPH can now expect an improved quality of life, said Dr. Steven Kaplan, attending urologist at NewYork-Presbyterian Hospital/Columbia University Medical Center and Given Foundation Professor of Urology, Columbia University College of Physicians Surgeons. Combination therapy using the drugs doxazosin and finasteride was shown to reduce the risk of the disease's overall clinical progression, defined as worsening of symptoms which include frequent or urgent need to urinate, slowing of the urinary stream and hesitancy in urinating incontinence, recurrent urinary tract infection, acute urinary retention, and a reduced ability of the kidney to perform its functions.

Additionally, the study's authors suggest that the combination therapy may reduce the necessity of surgery, which is the standard therapy for men who have developed complications of BPH.

The double-blind study followed 3,047 men with BPH over a four-and-a-half-year period. Study subjects were randomly given doxazosin, finasteride, the combination therapy or a placebo. The combination of the two drugs significantly delayed the clinical progression of BPH as compared with each drug individually among men with symptomatic BPH, the study concluded.

In June, another study published in The New England Journal of Medicine demonstrated that the drug finasteride reduces the risk of prostate cancer by 25 percent.

The study, whose principal investigator was Dr. John D. McConnell of the University of Texas Southwestern Medical Center, was funded by the National Institute of Diabetes, Digestive and Kidney Diseases. Other participating medical centers included Yale University School of Medicine, the Mayo Medical School and Northwestern University Feinberg School of Medicine.2453010pubjvb9001&&14:02-11- 5-2004kebloom16:49- 8-20-200401_05_04

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