Enlarged Prostate Treatment Study Shows Combination of Avodart and Tamsulosin Provides Greater Benefit Than Either Medication Alone

- Journal of Urology Publishes Combat Study Results -

PHILADELPHIA, January 18, 2008 /PRNewswire/ -- A study to be published in the February issue of the Journal of Urology shows that men with enlarged prostates who took a combination of two medications, AVODART (dutasteride) and tamsulosin, experienced significantly greater improvement in urinary symptoms than men prescribed either medication alone, GlaxoSmithKline said today.

The publication will mark the first time the full two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate, have appeared in a major medical journal.(1) Topline results were previously presented in September 2007 at the annual meeting of the Societe Internationale d'Urologie in Paris.

Enlarged prostate (also known as benign prostatic hyperplasia or BPH) is a progressive disease that affects 50 percent of men over the age of 50 and more than 90 percent of men over age 80.2 Common symptoms of enlarged prostate include frequent and/or urgent urination, which often is excessive at night, incomplete emptying, starting and stopping, and weak stream.(3)

AVODART belongs to a medicine class known as 5-alpha reductase inhibitors (5-ARIs). Over time, Avodart shrinks the prostate, improves symptoms and arrests the enlarged prostate disease process. Tamsulosin is an alpha blocker, a class of medicines that relaxes muscles in the bladder and prostate. Alpha blockers provide rapid symptom improvement, but do not reduce prostate size or modify the disease process.(2) The CombAT study is the first long-term assessment of the combination of AVODART and tamsulosin.(3)

"CombAT is an important contribution to our evolving understanding of the management of enlarged prostate," according to Steven A. Kaplan, M.D., from Weill Cornell Medical College of in New York City. Dr. Kaplan authored an editorial comment that will accompany the Journal of Urology publication of CombAT. "In this study, combination therapy yielded greater improvement in symptom score than either monotherapy within the first year of treatment, which appears to be a new finding. We then see in CombAT that this treatment difference holds true through Month 24."

In the CombAT study, male patients with moderate-to-severe enlarged prostate symptoms received placebo for four weeks and then were randomized to receive AVODART and tamsulosin as combination therapy, AVODART as monotherapy, or tamsulosin monotherapy (combination therapy, n=1610; AVODART, n=1623; tamsulosin, n=1611). The primary endpoint was the change in International Prostate Symptom Score (IPSS)* score from baseline at Month 24 for combination therapy compared to each medication alone.(3)

CombAT results showed at Month 24, that combination therapy demonstrated significantly greater symptom improvement for patients than either of the monotherapies (each comparison p<0.001). At Month 24, the mean decrease in IPSS from baseline was 6.2 points for combination therapy compared to 4.9 and 4.3 points for AVODART and tamsulosin, respectively.(3)

All therapy regimens employed in the study appear to be generally well- tolerated. Although the total number of drug-related adverse events was significantly greater in the combination group compared with either monotherapy group, only 5% or less of men in each treatment group withdrew from the study as a result of these adverse events. The most common (greater than or equal to 2%) adverse events for combination therapy were erectile dysfunction (7.4%), retrograde ejaculation (4.2%), altered or decreased libido (3.4%), and ejaculation failure (2.4%). The most common adverse events for AVODART as monotherapy were erectile dysfunction (6.0%) and altered or decreased libido (2.8%), and for tamsulosin monotherapy was erectile dysfunction (3.8%).(3)

* The International Prostate Symptom Score (IPSS) is a symptom index for enlarged prostate that was developed and validated by a multidisciplinary measurement committee of the American Urological Association (AUA). The final symptom index includes 7 questions covering frequency, nocturia, weak urinary (4)stream, hesitancy, intermittence, incomplete emptying and urgency.

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 suppresses DHT by 93 percent at 2 years.

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 healthcare provider 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 80.5 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 prostate-related surgery, and in rare cases even kidney or bladder damage.(6)

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.


    References:

    (1) McConnell J, Roehrborn C, Bautista O, et al. The Long-Term Effect of

        Doxazosin, Finasteride, and Combination Therapy on the Clinical

        Progression of Benign Prostatic Hyperplasia. N  Engl J Med 2003 Dec;

        349(25):2387-2398.

    (2) Mayo Clinic Staff. Enlarged Prostate (BPH).

        http://www.mayoclinic.com/health/enlarged-prostate

        bph/BP99999/PAGE=BP00009. Accessed on January 7, 2008.

    (3) Roehrborn C, Siami P, Barkin J, et al. The Effects of Dutasteride,

        Tamsulosin and Combination Therapy on Lower Urinary Tract Symptoms in

        Men with Benign Prostatic Hyperplasia and Prostatic Enlargement: 2

        Year Results from the CombAT Study. J Urol 2008 Feb; 179: 616-621.

    (4) Barry MJ, Fowler FJ Jr, O'Leary MP, et al. The American Urological

        Association symptom index for benign prostatic hyperplasia. J Urol

        1992 Nov; 148(5):1549-57. Accessed on January 7, 2008 via

        http://www.primeanswers.org/primeanswers/calculators/bph.cfm

    (5) 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 Professions Division: 2000:399-421.

    (6) National Institute for Diabetes and Digestive and Kidney Disease

        (NIDDK). Prostate Enlargement:  Benign Prostatic Hyperplasia.

        http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement/

        index.htm. Accessed on December 7, 2007.



    US Media Inquiries:              Rob Perry      (919) 483 2839


    US Analyst/Investor Inquiries:   Frank Murdolo  (215) 751 7002

                                     Tom Curry      (215) 751 5419

CONTACT: US Media Inquiries, Rob Perry, +1-919-483 2839; US Analyst -Investor Inquiries, Frank Murdolo, +1-215-751 7002 or, Tom Curry,+1-215-751 5419

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

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Posted: January 2008

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