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

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

Research output: Contribution to journalArticle

35 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)450-459
Number of pages10
JournalBJU International
Volume116
Issue number3
DOIs
StatePublished - Sep 1 2015

Fingerprint

tamsulosin
Watchful Waiting
Prostatic Hyperplasia
Life Style
Prostate
Safety
Quality of Life
Therapeutics
Quality Improvement
Dutasteride

Keywords

  • benign prostatic hyperplasia
  • dutasteride
  • fixed-dose combination
  • lower urinary tract symptoms
  • tamsulosin
  • watchful waiting

ASJC Scopus subject areas

  • Urology

Cite this

@article{2d28f093ce6940afac02ccc1c58fb301,
title = "Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart{\circledR}) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-na{\"i}ve 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-na{\"i}ve 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.",
keywords = "benign prostatic hyperplasia, dutasteride, fixed-dose combination, lower urinary tract symptoms, tamsulosin, watchful waiting",
author = "Claus Roehrborn and {Oyarzabal Perez}, Igor and Roos, {Erik P M} and Nicolae Calomfirescu and Betsy Brotherton and Fang Wang and Palacios, {Juan Manuel} and Averyan Vasylyev and Manyak, {Michael J.}",
year = "2015",
month = "9",
day = "1",
doi = "10.1111/bju.13033",
language = "English (US)",
volume = "116",
pages = "450--459",
journal = "BJU International",
issn = "1464-4096",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - 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

T2 - 2-year CONDUCT study results

AU - Roehrborn, Claus

AU - Oyarzabal Perez, Igor

AU - Roos, Erik P M

AU - Calomfirescu, Nicolae

AU - Brotherton, Betsy

AU - Wang, Fang

AU - Palacios, Juan Manuel

AU - Vasylyev, Averyan

AU - Manyak, Michael J.

PY - 2015/9/1

Y1 - 2015/9/1

N2 - 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.

AB - 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.

KW - benign prostatic hyperplasia

KW - dutasteride

KW - fixed-dose combination

KW - lower urinary tract symptoms

KW - tamsulosin

KW - watchful waiting

UR - http://www.scopus.com/inward/record.url?scp=84938883251&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84938883251&partnerID=8YFLogxK

U2 - 10.1111/bju.13033

DO - 10.1111/bju.13033

M3 - Article

C2 - 25565364

AN - SCOPUS:84938883251

VL - 116

SP - 450

EP - 459

JO - BJU International

JF - BJU International

SN - 1464-4096

IS - 3

ER -