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FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
Date:6/19/2008

n was superior to both monotherapies at Month 12 and continued to Month 24. The primary endpoint was the change in International Prostate Symptom Score (IPSS) from baseline at Month 24 for combination therapy compared to each medication alone. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.

Data from the remaining 2 years of the CombAT study will provide further information on the pattern of symptoms and long-term outcomes associated with combination therapy vs. AVODART and tamsulosin monotherapies.

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=1610), AVODART 0.5 mg/day (n=1623), or tamsulosin 0.4 mg/day (n=1611).

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 symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of prostate-related surgery. AVODART is now indicated in combination wi
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SOURCE GlaxoSmithKline
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