April 2004

Contact:Michael Fleming
919-483-2839
GlaxoSmithKline

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

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%).

About AVODART

AVODART, the first and only dual 5ARI for the treatment of BPH, inhibits both the type I and type II isoenzymes responsible for the conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary male hormone responsible for the enlargement of the prostate. AVODART provides the power to suppress DHT by 93%, reduces prostate volume as early as 1 month, improves symptoms and arrests the BPH disease process.

AVODART is indicated for the treatment of symptomatic BPH in men with an enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention, and reduce the risk of prostate surgery. While some men have fewer problems and symptoms after 3 months of treatment with AVODART, a treatment period of at least 6 months is usually necessary to see if AVODART will improve symptoms. Only a doctor can tell if symptoms are from an enlarged prostate and not a more serious condition such as prostate cancer. Women and children should not take AVODART. Women who are, or could become, pregnant should not handle AVODART due to the possibility of a specific birth defect. Men treated with AVODART should not donate blood until at least 6 months after their final dose. Caution should be used in patients with liver disease. Possible side effects include sexual side effects and breast tenderness and/or swelling. These side effects occur infrequently. For full prescribing information, see www.avodart.com.

About BPH

Benign prostatic hyperplasia (BPH) is a prevalent and progressive condition in aging men, effecting 90% of men over the age of 80 and 50% of men aged over age 50.⁽²⁾ The progressive nature of the disease is associated with an increased risk of acute urinary retention (a sudden inability to urinate) and BPH-related surgery. The 2003 AUA guidelines recommend the use of a 5ARI as an appropriate and effective option for the treatment of men with symptomatic BPH and an enlarged prostate.

About AUA-SI

The AUA-SI is a tool used in evaluating the severity of BPH symptoms, including frequent or urgent urination, weak or intermittent urine stream, sensation of incomplete emptying, the need to strain and frequent urination during bedtime hours. Patients with AUA-SI scores of 7 or less are considered to have mild symptoms. Patients with AUA-SI scores between 8 and 19 are considered to have moderate symptoms and those with scores of 20 to 35 are classified as having severe symptoms. An improvement in AUA-SI score of 3 points or greater is considered meaningful to the patient.⁽³⁾

About GSK

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Company information line: 1-888-825-5249. Website address: www.gsk.com

References
1. Roehrborn C, Marks L, Fenter T, et al. Efficacy and Safety of Dutasteride in the Four-Year Treatment of men with Benign Prostatic Hyperplasia. Urology. 2004; 63(4): 709-715.
2. Presti JC Jr. Neoplasms of the prostate gland. In: Tanagho EA, McAninch JW, eds. Smith's General Urology. 15th ed. New York, NY: Lange Medical Books/ McGraw-Hill Health Professions Division; 2000: 399-421.
3. Barry M, Williford W, Chang Y, et al. Benign Prostatic Hyperplasia specific health status measures in clinical research: How much change in the American Urological Association symptom index and the Benign Prostatic Hyperplasia Impact Index is perceptible to patients? Urology. 1995; 154: 1770-1774.

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