Portal de Periódicos da CAPES

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 t

2015; Wiley; Volume: 116; Issue: 3 Linguagem: Inglês

10.1111/bju.13033

1464-410X

Claus G. Roehrborn, Igor Oyarzabal Perez, Erik P.M. Roos, N. Calomfirescu, Betsy Brotherton, Fang Wang, Juan Manuel Segura Palacios, Averyan Vasylyev, Michael J. Manyak,

Hormonal and reproductive studies

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 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 Methods This was a multicentre, randomised, open‐label, parallel‐group study ( NCT 01294592) 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. Results The 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. Conclusion FDC 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.