Claus G Roehrborn1, Igor Oyarzabal Perez2, Erik P M Roos3, Nicolae Calomfirescu4, Betsy Brotherton5, Fang Wang6, Juan Manuel Palacios7, Averyan Vasylyev8, Michael J Manyak5. 1. Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA. 2. Department of Urology, Mendaro Hospital, Gipuzkoa, Spain. 3. Department of Urology, Antonius Hospital Sneek, Sneek, The Netherlands. 4. Urology Clinic, Uroandromed, Bucharest, Romania. 5. GlaxoSmithKline, Research Triangle Park, NC, USA. 6. GlaxoSmithKline, King of Prussia, PA, USA. 7. Urology, Classic & Established Medicines, GlaxoSmithKline, Madrid, Spain. 8. Urology, Classic and Established Medicines, GlaxoSmithKline, London, UK.
Abstract
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 (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. 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.
RCT Entities:
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 (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. 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.
Authors: Abdulmaged M Traish; Roberto Cosimo Melcangi; Marco Bortolato; Luis M Garcia-Segura; Michael Zitzmann Journal: Rev Endocr Metab Disord Date: 2015-09 Impact factor: 6.514
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Authors: Wei Chen; Laura E Pascal; Ke Wang; Rajiv Dhir; Alexa M Sims; Robert Campbell; Gwenyth Gasper; Donald B DeFranco; Naoki Yoshimura; Zhou Wang Journal: Prostate Date: 2020-07-13 Impact factor: 4.104