Methods: 327 BPH patients were randomised to 0.5 mg dutasteride and 0.4 mg tamsulosin for 36 weeks (DT36) or 0.5 me, dutasteride and 0.4 mg tamsulosin for 24 weeks followed by dutasteride and tamsulosin matched placebo for the remaining 12 weeks (DT24 + D12). Patients' assessment of their symptoms, IPSS at weeks 24, 30, and drug safety were evaluated.

Results: 77% of DT24 + D12 patients felt the same/better at week 30 compared with week 24 (changes in IPSS were consistent with this finding). Of those subjects with an IPSS <20 who changed to dutasteride monotherapy at week 24, 84% switched without a noticeable deterioration in their symptoms. In the 27% of men with severe baseline symptoms (IPSS greater than or equal to20) who had withdrawal of tamsulosin therapy at week 24, 42.5% reported a worsening of their symptoms compared with 14% in the DT36 group. The regimens were well tolerated.

Conclusions: Dutasteride can be used in a 24-week combination with tamsulosin, to achieve rapid onset of symptom relief in patients at risk of underlying disease progression. This symptom relief is maintained in the majority of patients after the alpha(1)-blocker is removed from the combination. Patients with severe symptoms may benefit from longer-term combination therapy. (C) 2003 Elsevier B.V. All rights reserved.