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Study Shows Combination Therapy Incorporating Avodart and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years

PHILADELPHIA, Pa., September 04, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced new results from a large study that demonstrate combination treatment with AVODART (dutasteride) and the alpha blocker tamsulosin provides significantly greater urinary symptom improvement for men with enlarged prostate than either AVODART or tamsulosin monotherapy over 24 months. Three analyses from the study - Combination therapy with Avodart and tamsulosin (CombAT) - were presented today at the 29th annual meeting of the Societe Internationale d'Urologie in Paris.

In addition, one of three analyses presented -- a post hoc analysis -- showed that AVODART provides a pattern of increasing enlarged prostate symptom improvement over 24 months. Tamsulosin -- the most commonly prescribed medicine for the condition -- provided early symptom improvement, but this improvement plateaued from month three through 24.1 Common symptoms of enlarged prostate include nocturia, frequency and urgency, incomplete emptying, starting and stopping, and weak stream.

The CombAT study includes 4,800 men (combination therapy, n=1492; AVODART, n=1502; tamsulosin, n=1519) with moderate-to-severe enlarged prostate symptoms. All study participants received placebo for four weeks and then were randomized to receive AVODART and tamsulosin combination therapy, AVODART monotherapy, or tamsulosin monotherapy.

Enlarged prostate (also known as benign prostatic hyperplasia (BPH)), is a condition that affects 50 percent of men over the age of 50 and more than 90 percent of men over age 80. AVODART belongs to a class of medicines known as 5 alpha reductase inhibitors (5 ARIs), which shrink the prostate over time. Tamsulosin is an alpha blocker, a class of medicines that relaxes muscles in the bladder and prostate.

"This study provides important new data to guide initial therapy for men with symptomatic BPH," said Claus Roehrborn, M.D., Professor and Chairman, Department of Urology, UT Southwestern Medical Center at Dallas and CombAT principal investigator. "This is the first time we have seen a benefit for combination therapy over monotherapy during the first 12 months of treatment."

CombAT Two-Year Results

The findings reported today are intermediate results from a study that remains active. Researchers will issue a final report at the end of four years regarding the efficacy of AVODART, tamsulosin, and combination therapy in reducing the risk of symptomatic disease progression and the risk of urinary retention (AUR) and prostate surgery in men with moderate-to-severe enlarged prostate symptoms.

Poster presentation: "The effects of dutasteride, tamsulosin, and combination therapy on lower urinary tract symptoms and Qmax in men with BPH and prostatic enlargement"

According to this analysis, the two-year primary endpoint was achieved in the CombAT study. Symptom improvement was measured using the International Prostate Symptom Score (IPSS), a validated assessment questionnaire recommended by the American Urological Association (AUA). Over 24 months, AVODART and tamsulosin combination therapy provided a significantly greater (p < 0.001) improvement in symptoms (IPSS) from baseline (6.2 units) than either AVODART (4.9 units) or tamsulosin (4.3 units) treatment alone. In fact, the CombAT study demonstrated the benefit of combination therapy over both monotherapies in the first 12 months of treatment. With combination therapy, patients experienced continuous improvement of symptoms throughout the two years of the study.

Poster presentation: "Dutasteride provides greater improvement in symptoms and Qmax than tamsulosin in men with moderate-to-severe symptoms of BPH and prostate enlargement"

This post hoc analysis of the CombAT two-year data is a comparison of efficacy for AVODART and tamsulosin monotherapies. According to the post hoc analysis, AVODART monotherapy resulted in a pattern of continuous and increasing symptom improvement over 2 years (IPSS at Month 3: 2.8 units; IPSS at Month 24: 4.9 units). Patients taking tamsulosin showed similar symptom improvement at Month 3 through Month 24 (IPSS at Month 3: 4.5 units; IPSS at Month 24: 4.3 units). Furthermore, AVODART resulted in continuous and sustained Qmax (urine flow rate) improvements to Month 24.

The third analysis presented covered the safety and tolerability of the treatment regimens. All therapy regimens employed in the study appear to be generally well-tolerated. The profile of events for combination therapy was consistent with those reported for monotherapies. The most common adverse events for combination therapy were erectile dysfunction (7.4%), retrograde ejaculation (4.2%) and altered or decreased libido (3.4%). The most common adverse events for AVODART monotherapy were erectile dysfunction (6.0%), altered or decreased libido (2.8%) and breast enlargement (1.8%), while the most common adverse events for tamsulosin monotherapy were erectile dysfunction (3.8%), altered or decreased libido (1.7%) and dizziness (1.7%).

About CombAT

CombAT is a multicenter, randomized, double-blind and parallel-group study. Men [aged greater than or equal to 50 years with a prostate volume (PV) greater than or equal to 30 cc, serum prostate-specific antigen (PSA) level 1.5-10 ng/mL, Qmax > 5 and less than or equal to 15 mL/sec with a minimum voided volume greater than or equal to 125 mL and International Prostate Symptom Score (IPSS) greater than or equal to 12] with moderate-to-severe enlarged prostate symptoms received placebo for four weeks and were then randomized to receive AVODART 0.5 mg/day and tamsulosin 0.4 mg/day (n=1492), AVODART 0.5 mg/day (n=1502), or tamsulosin 0.4 mg/day (n=1519).

ABOUT AVODART

AVODART, the first and only dual 5ARI for the treatment of enlarged prostate, 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 percent at 2 years. Over time, AVODART reduces prostate volume, improves symptoms and arrests the enlarged prostate disease process.

AVODART is indicated for the treatment of symptomatic enlarged prostate in men with an enlarged prostate to improve urinary symptoms, reduce the risk of AUR, and reduce the risk of enlarged prostate-related surgery. While some men have fewer problems and symptoms after three months of treatment with AVODART, a treatment period of at least six 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. Men should see their doctors for regular exams. Women and children should not take AVODART. Women who are, or could become pregnant should not handle AVODART due to the potential risk of a specific birth defect. Men treated with AVODART should not donate blood until at least six 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 Enlarged Prostate

Enlarged prostate is a prevalent and progressive condition that affects 50 percent of men over 50 years of age and over 90 percent of men older than age 80. An enlarged prostate causes changes in urinary habits because of its location around the urethra. Over time, the prostate can continue to grow and urinary symptoms may worsen as the bladder loses the ability to empty itself. Left untreated, in severe cases, an enlarged prostate can lead to serious long-term problems including acute urinary retention (AUR) and the need for surgery, and in rare cases even kidney or bladder damage.

About GlaxoSmithKline

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

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this press release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the 'Operating and Financial Review and Prospects' in the company's Annual Report 2006.

    Contact:  Robert Perry

              GlaxoSmithKline

              (919) 483 2839

              

robert.p.perry@gsk.com

CONTACT: Robert Perry of GlaxoSmithKline, +1-919-483-2839, robert.p.perry@gsk.com

Web site: http://www.gsk.com/http://www.avodart.com/

Ticker Symbol: (NYSE:GSK)

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Posted: September 2007

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