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Title: Dutasteride Plus Tamsulosin Approved for Benign Prostatic Hyperplasia in Sweden

"Dutasteride Plus Tamsulosin Approved for Benign Prostatic Hyperplasia in Sweden"

LONDON -- April 22, 2008 -- Dutasteride (Avodart), the only dual-acting 5-alpha reductase inhibitor, is now available in Sweden in combination with tamsulosin for the treatment of patients with symptoms of moderate to severe benign prostatic hyperplasia (BPH). Approval was granted through the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State. Further approvals are anticipated in the coming months across 26 European countries. The approval was based on positive 2-year results from the ongoing Combination of Avodart and Tamsulosin (CombAT) study in men with moderate to severe BPH symptoms, which showed that combination therapy with dutasteride and tamsulosin provides significantly superior and sustained improvements in symptoms (1), peak urinary flow (1), and quality of life (2) versus either agent alone. The combination of dutasteride and tamsulosin has also been shown to provide significantly superior and sustained improvements in BPH symptoms versus dutasteride alone from month 3 and versus tamsulosin alone from month 9.(1) This is the first time combination therapy has been shown to provide superior BPH symptom improvement versus both monotherapies in less than 1 year.(1, 3-7) The CombAT trial is an ongoing 4-year, randomised, double-blind, multicentre (446 investigators in 35 countries), parallel-group study investigating the efficacy and safety of dutasteride 0.5 mg and tamsulosin 0.4 mg -- separately and in combination -- in 4,844 men with moderate to severe BPH symptoms (international prostate symptom score >= 12), a prostate volume >= 30 cc, and serum prostate-specific antigen >= 1.5 ng/mL. The 2-year CombAT results demonstrated that the combination therapy provided significantly superior and sustained improvement in symptoms, urinary flow, and quality of life than either monotherapy over 2 years.(1,2) The CombAT study, still ongoing, will also evaluate, at 4 years, the efficacy of dutasteride and tamsulosin combination therapy versus each agent alone in reducing the risk of acute urinary retention and BPH-related surgery. At 2 years, the profile of adverse events for combination therapy was consistent with those reported for either monotherapy. Although drug-related adverse events (mainly sexually related) were more common with combination therapy, rates of withdrawal from the study due to adverse events were low (<= 5%) across all treatment groups.(1) References 1. Roehrborn CG et al. [J Urol. 2008;179:616-621. Discussion 621.

2. Barkin J et al, for the CombAT Study Group. Eur Urol Supplements. 2008;7:95. Abstract 99.
3. Lepor H et al. N Engl J Med. 1996;335:533-539.
4. Lepor H et al. J Urol. 1998;160:1358-1367.
5. Debruyne FM et al. Eur Urol. 1998;34:169-175.
6. Kirby RS et al. Urology. 2003;61:119-126.
7. McConnell JD et al. N Engl J Med. 2003;349:2387-2398.

SOURCE: GlaxoSmithKline

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