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Clinical Research

The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study

Prostate Cancer and Prostatic Diseases volume 14, pages 302–306 (2011)Cite this article

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Abstract

CombAT (Combination of Avodart and Tamsulosin) was a randomised, double-blind study in men (n=4844) aged ⩾50 years with a clinical diagnosis of BPH. Patients were randomised to daily tamsulosin 0.4 mg, dutasteride 0.5 mg or both for 4 years. The primary endpoint was time to acute urinary retention (AUR) or BPH-related surgery. Secondary endpoints included BPH clinical progression, symptoms and maximum urinary flow rate. A post hoc analysis of data from the European subgroup was conducted. A total of 2925 men were randomised to treatment in Europe as part of CombAT (tamsulosin, n=972; dutasteride, n=970; combination, n=983). Combination therapy significantly reduced the relative risk of AUR or BPH-related surgery compared with either monotherapy at 4 years, and also significantly reduced the risk of BPH clinical progression. Combination therapy also provided significantly greater symptom improvement than either monotherapy at 4 years. Safety and tolerability of dutasteride plus tamsulosin was consistent with previous experience of this combination and with the monotherapies. These data provide further evidence to support the use of long-term combination therapy (dutasteride plus tamsulosin) in men with moderate-to-severe lower urinary tract symptoms because of BPH and prostatic enlargement. The results in the European subgroup are generally consistent with those in the overall study population.

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Acknowledgements

This study was funded by GlaxoSmithKline. Medical writing assistance in the preparation of this paper was provided by Tony Reardon of Spirit Medical Communications and funded by GlaxoSmithKline.

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Authors and Affiliations

  1. Université F Rabelais, CHRU, Tours, France,

    O Haillot

  2. Instituto Português Oncologia, Oncologia Molecular, Porto, Portugal

    A Fraga

  3. WSS im L Rydygiera, Krakow, Poland

    P Maciukiewicz

  4. Department of Urology, Moscow State Medical Stomatological University, Moscow, Russia

    D Pushkar

  5. Department of Urology, Tampere University Hospital, Tampere, Finland

    T Tammela

  6. Evangelisches Krankenhaus Oberhausen, Klinik für Urologie, Oberhausen, Germany

    K Höfner

  7. Jefe de Servicio de Urología, CHU A Coruña, Spain

    V Chantada

  8. Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, Raleigh, NC, USA

    P Gagnier

  9. Biostatistics, GlaxoSmithKline, Research Triangle Park, Raleigh, NC, USA

    B Morrill

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  1. O Haillot
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Correspondence to O Haillot.

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Competing interests

Drs Haillot, Fraga, Maciukiewicz, Pushkar, Tammela, Höfner and Chantada have been investigators in studies sponsored by GlaxoSmithKline. Dr Tammela has acted as an advisor to GlaxoSmithKline. Paul Gagnier and Betsy Morrill are employees of GlaxoSmithKline.

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Haillot, O., Fraga, A., Maciukiewicz, P. et al. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis 14, 302–306 (2011). https://doi.org/10.1038/pcan.2011.13

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