title: 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.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: Department of Urology, Mendaro Hospital, Gipuzkoa, Spain.
authors.forename: Igor
authors.initials: I
authors.lastname: Oyarzabal Perez
authors.affiliation: Department of Urology, Antonius Hospital Sneek, Sneek, The Netherlands.
authors.forename: Erik P M
authors.initials: EP
authors.lastname: Roos
authors.affiliation: Urology Clinic, Uroandromed, Bucharest, Romania.
authors.forename: Nicolae
authors.initials: N
authors.lastname: Calomfirescu
authors.affiliation: GlaxoSmithKline, Research Triangle Park, NC, USA.
authors.forename: Betsy
authors.initials: B
authors.lastname: Brotherton
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA.
authors.forename: Fang
authors.initials: F
authors.lastname: Wang
authors.affiliation: Urology, Classic & Established Medicines, GlaxoSmithKline, Madrid, Spain.
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Palacios
authors.affiliation: Urology, Classic and Established Medicines, GlaxoSmithKline, London, UK.
authors.forename: Averyan
authors.initials: A
authors.lastname: Vasylyev
authors.affiliation: GlaxoSmithKline, Research Triangle Park, NC, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Manyak
mesh_terms: D000368:Aged; D001378:Azasteroids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068538:Dutasteride; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000145:classification / Q000188:drug therapy* / Q000453:epidemiology* / Q000473:pathology; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D064804:Urological Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D057832:Watchful Waiting
chemical_list: D001378:Azasteroids; D013449:Sulfonamides; D064804:Urological Agents; D000077409:Tamsulosin; D000068538:Dutasteride
keywords: benign prostatic hyperplasia; dutasteride; fixed-dose combination; lower urinary tract symptoms; tamsulosin; watchful waiting