ObjectiveTo 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 of tamsulosin therapy if symptoms did not improve (WW-All) in treatment-naïve men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression. Patients and MethodsThis was a multicentre, randomised, open-label, parallel-group study (NCT01294592) in 742 men with an International Prostate Symptom Score (IPSS) of 8-19, prostate volume ≥30 mL and total serum PSA level of ≥1.5 ng/mL. Patients were randomised to FDC (369 patients) or WW-All (373) and followed for 24 months. All patients were given lifestyle advice. The primary endpoint was symptomatic improvement from baseline to 24 months, measured by the IPSS. Secondary outcomes included BPH clinical progression, impact on quality of life (QoL), and safety. ResultsThe change in IPSS at 24 months was significantly greater for FDC than WW-All (-5.4 vs −3.6 points, P < 0.001). With FDC, the risk of BPH progression was reduced by 43.1% (P < 0.001); 29% and 18% of men in the WW-All and FDC groups had clinical progression, respectively, comprising symptomatic progression in most patients. Improvements in QoL (BPH Impact Index and question 8 of the IPSS) were seen in both groups but were significantly greater with FDC (P < 0.001). The safety profile of FDC was consistent with established profiles of dutasteride and tamsulosin. ConclusionFDC therapy with dutasteride and tamsulosin, plus lifestyle advice, resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with WW plus initiation of tamsulosin as per protocol.Keywords benign prostatic hyperplasia, dutasteride, fixed-dose combination, lower urinary tract symptoms, tamsulosin, watchful waiting [Correction added on 13 February 2015 after first online publication: The trademark symbol for 'Duodart' has been changed to a registered symbol]

PurposeTo investigate (in a post hoc analysis of the 2-year CONDUCT study) the characteristics and clinical outcomes of men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression who benefitted from lifestyle changes alone.MethodsPatients were given lifestyle advice and randomized to a fixed-dose combination (FDC) of dutasteride and tamsulosin or watchful waiting (WW) and followed for 24 months. Patients in the WW group were escalated to tamsulosin if any follow-up International Prostate Symptom Score (IPSS) was equal or greater than the baseline value. Improvements in symptoms (change in IPSS) and quality of life [measured by BPH Impact Index (BII) and question 8 of the IPSS (IPSS-Q8)] were analysed in the FDC group, men who initiated tamsulosin (WW-TAM) and men who received no medical intervention (WW-no treatment) and the impact of baseline variables on IPSS determined.ResultsThe adjusted mean decrease in IPSS, BII and IPSS-Q8 at each post-baseline visit over 24 months appeared greater in the FDC (n = 369) and WW-no treatment groups (n = 144) than in the WW-TAM group (n = 229). IPSS improvements appeared similar in the FDC group and WW-no treatment subgroup, except in patients with the greatest degree of bother at baseline (BII 7–13).ConclusionBII at baseline may be a more relevant indicator than symptom severity as to whether a patient with moderate symptoms should receive medical therapy or not.