Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo

Claus Roehrborn, Adolfo Casabé, Sidney Glina, Sebastian Sorsaburu, Carsten Henneges, Lars Viktrup

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objectives: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5mg with finasteride 5mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. Methods: An international, randomized, double-blind, parallel study was carried out in men aged ≥45years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. Results: Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P=0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P≥0.371). Conclusions: Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.

Original languageEnglish (US)
Pages (from-to)582-587
Number of pages6
JournalInternational Journal of Urology
Volume22
Issue number6
DOIs
StatePublished - Jun 1 2015

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Finasteride
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Double-Blind Method
Placebos
Confidence Intervals
Prostate
Therapeutics
5-alpha Reductase Inhibitors
Tadalafil
Clinical Protocols
Random Allocation

Keywords

  • Benign prostatic hyperplasia
  • Finasteride
  • Lower urinary tract symptoms
  • Tadalafil
  • Treatment satisfaction

ASJC Scopus subject areas

  • Urology

Cite this

@article{d04ac476532a405eb11f87254c3e80dd,
title = "Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo",
abstract = "Objectives: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5mg with finasteride 5mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. Methods: An international, randomized, double-blind, parallel study was carried out in men aged ≥45years who were 5-alpha reductase inhibitor na{\"i}ve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25{\%} from randomization. Results: Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week4 was 57.0{\%} and 47.9{\%} (OR 1.45, 95{\%} confidence interval 1.07-1.97), at week12 was 68.8{\%} and 60.7{\%} (OR 1.48, 95{\%} confidence interval 1.07-2.05) and at week26 was 71.4{\%} and 70.2{\%} (OR 1.14, 95{\%} confidence interval 0.81-1.61); for IPSS change ≥25{\%}, the corresponding proportions were 44.8{\%} and 32.9{\%} (OR 1.66, 95{\%} confidence interval 1.21-2.28), 55.5{\%} and 51.9{\%} (OR 1.18, 95{\%} confidence interval 0.87-1.62), and 62.0{\%} and 58.3{\%} (OR 1.23, 95{\%} confidence interval 0.89-1.70). Treatment satisfaction at week26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P=0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P≥0.371). Conclusions: Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.",
keywords = "Benign prostatic hyperplasia, Finasteride, Lower urinary tract symptoms, Tadalafil, Treatment satisfaction",
author = "Claus Roehrborn and Adolfo Casab{\'e} and Sidney Glina and Sebastian Sorsaburu and Carsten Henneges and Lars Viktrup",
year = "2015",
month = "6",
day = "1",
doi = "10.1111/iju.12741",
language = "English (US)",
volume = "22",
pages = "582--587",
journal = "International Journal of Urology",
issn = "0919-8172",
publisher = "Wiley-Blackwell",
number = "6",

}

TY - JOUR

T1 - Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia

T2 - Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo

AU - Roehrborn, Claus

AU - Casabé, Adolfo

AU - Glina, Sidney

AU - Sorsaburu, Sebastian

AU - Henneges, Carsten

AU - Viktrup, Lars

PY - 2015/6/1

Y1 - 2015/6/1

N2 - Objectives: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5mg with finasteride 5mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. Methods: An international, randomized, double-blind, parallel study was carried out in men aged ≥45years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. Results: Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P=0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P≥0.371). Conclusions: Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.

AB - Objectives: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5mg with finasteride 5mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. Methods: An international, randomized, double-blind, parallel study was carried out in men aged ≥45years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. Results: Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P=0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P≥0.371). Conclusions: Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.

KW - Benign prostatic hyperplasia

KW - Finasteride

KW - Lower urinary tract symptoms

KW - Tadalafil

KW - Treatment satisfaction

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U2 - 10.1111/iju.12741

DO - 10.1111/iju.12741

M3 - Article

C2 - 25827166

AN - SCOPUS:84930381466

VL - 22

SP - 582

EP - 587

JO - International Journal of Urology

JF - International Journal of Urology

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