Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart(®) ) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-naïve men with moderately symptomatic benign prostatic hyperplasia: 2-year CONDUCT study results.

摘要: Objective To investigate whether a fixed-dose combination (FDC) of 0.5 mg dutasteride and 0.4 mg tamsulosin is more effective than watchful waiting with protocol-defined initiation therapy if symptoms did not improve (WW-All) in treatment-naive men moderately symptomatic benign prostatic hyperplasia (BPH) at risk progression. Patients Methods This was multicentre, randomised, open-label, parallel-group study (NCT01294592) 742 an International Prostate Symptom Score (IPSS) 8–19, prostate volume ≥30 mL total serum PSA level ≥1.5 ng/mL. Patients were randomised to FDC (369 patients) or WW-All (373) followed for 24 months. All patients given lifestyle advice. The primary endpoint improvement from baseline months, measured by the IPSS. Secondary outcomes included BPH clinical progression, impact on quality life (QoL), safety. Results The change IPSS months significantly greater (–5.4 vs −3.6 points, P < 0.001). With FDC, progression reduced 43.1% (P 0.001); 29% 18% groups had respectively, comprising most patients. Improvements QoL (BPH Impact Index question 8 IPSS) seen both but safety profile consistent established profiles tamsulosin. Conclusion FDC tamsulosin, plus advice, resulted rapid sustained improvements moderate symptom compared WW as per protocol.