PHILADELPHIA -- June 23, 2008 -- The US Food and Drug Administration (FDA) has approved dutasteride (Avodart) in combination with tamsulosin for the treatment of symptomatic enlarged prostate. The new indication reflects emerging research showing the combination of the 2 medications treats the symptoms of enlarged prostate more effectively than either medication alone.
"The combination of [dutasteride] and tamsulosin at diagnosis allows doctors to simultaneously treat the patient's prostate on 2 fronts by reducing prostate size and rapidly improving symptoms," said Steven A. Kaplan, MD, Weill Cornell Medical College of Cornell University, New York, New York.
Dutasteride is already approved by the FDA for the treatment of enlarged prostate to improve urinary symptoms, to reduce the risk of acute urinary retention (AUR), and to reduce the risk of prostate-related surgery. Tamsulosin is also already indicated for the treatment of the signs and symptoms of enlarged prostate.
The FDA approval was based on 2-year results of the Combat (Combination of Avodart and Tamsulosin) study. The Combat study is the first long-term assessment of the combination of dutasteride and an alpha-blocker. The study is a multicentre, randomised, double-blind, and parallel-group study. Men with moderate-to-severe enlarged prostate symptoms received placebo for 4 weeks and were then randomised to receive dutasteride and tamsulosin, dutasteride alone, or tamsulosin alone.
The Combat study results showed that combination therapy with dutasteride and tamsulosin was superior to both monotherapies at month 12 and continued to month 24.
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 versus dutasteride and tamsulosin monotherapies.
SOURCE: GlaxoSmithKline
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