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Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
Date:9/4/2007

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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 t
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SOURCE GlaxoSmithKline
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