New study demonstrates significant and sustained improvements in BPH symptoms with AVODART ™

04/14/04

Data published in the April 2004 issue of Urology supports long-term use of AVODART in men with symptomatic BPH and an enlarged prostate

Philadelphia, PA, April 14, 2004 New clinical study findings showed that men with symptoms of benign prostatic hyperplasia (BPH), also known as enlarged prostate, taking AVODART for four years had sustained, long-term improvement in three major markers of BPH -- urinary symptoms, urinary flow rates and prostate volume reduction. AVODART is the first and only dual 5alpha-reductase (5AR) inhibitor approved for the treatment of BPH.

The new data, published in the April 2004 issue of Urology, are the pooled results from two recent US phase III multi-center, randomized, placebo-controlled trials of two year duration with a two year open-label extension.

Men taking AVODART for all four years experienced a significant improvement in urinary symptoms (mean of 6.1 point reduction in American Urological Association Symptom Index (AUA-SI)) as well as significant prostate volume reduction (26.2 percent compared to baseline). Men treated with two years of placebo followed by two years of AVODART experienced an average symptom improvement of 5.3 points on the AUA-SI and a 20.7 percent prostate volume reduction compared to baseline.

"Physicians now have compelling evidence that long-term use of AVODART in men with BPH provides meaningful, sustained and significant symptom improvements," said Claus Roehrborn, MD, the principal trial investigator, professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center, Dallas. "BPH is a prevalent and progressive disease. This study demonstrates that AVODART effectively improves symptoms, reduces the volume of the prostate and arrests the disease process."

A total of 2,802 men were randomized into the double-blind phase of the two studies; 1,908 completed the two year double-blind portion. In the open-label phase, 1,570 subjects were enrolled, 778 of whom previously received placebo, and 792 who previously received AVODART. Overall, 569 subjects received AVODART for 4 years. (1)

"The improvements compared to baseline demonstrate the ability of AVODART to help ease the symptoms of BPH, which can help improve the quality of life for the patient," commented Dr. Roehrborn.

Additionally, long-term treatment resulted in a low incidence of drug-related side effects. The incidence of drug-related side effects decreased with duration of treatment. In year four, the most frequently observed drug-related side effects for men treated with AVODART for four years were: gynecomastia (breast enlargement and breast tenderness) (1%); impotence (0.4%); ejaculation disorders (0.1%).

Source: Eurekalert & others

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