Enlarged Prostate Treatment Study Shows Combination of AVODART(R) and Tamsulosin Provides Greater Benefit Than Either Medica...(will accompany the Journal ofUrology pub...),Health

Date:1/18/2008

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 (
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SOURCE GlaxoSmithKline Copyright©2008 PR Newswire. All rights reserved

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