Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: Analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies

Hartmut Porst, Claus Roehrborn, Roberta J. Secrest, Anne Esler, Lars Viktrup

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated.

Original languageEnglish (US)
Pages (from-to)2044-2052
Number of pages9
JournalJournal of Sexual Medicine
Volume10
Issue number8
DOIs
StatePublished - Aug 2013

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Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Erectile Dysfunction
Prostate
Placebos
Prostate-Specific Antigen
Tadalafil
Clinical Studies
Random Allocation
Quality of Life
Outcome Assessment (Health Care)
Safety
Therapeutics

Keywords

  • Benign Prostatic Hyperplasia
  • Erectile Dysfunction
  • Lower Urinary Tract Symptoms
  • LUTS/BPH
  • PDE5 Inhibitor
  • Tadalafil

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynecology
  • Reproductive Medicine
  • Medicine(all)

Cite this

@article{8d605c4747094657a3c5724b4bbc25a5,
title = "Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: Analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies",
abstract = "Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated.",
keywords = "Benign Prostatic Hyperplasia, Erectile Dysfunction, Lower Urinary Tract Symptoms, LUTS/BPH, PDE5 Inhibitor, Tadalafil",
author = "Hartmut Porst and Claus Roehrborn and Secrest, {Roberta J.} and Anne Esler and Lars Viktrup",
year = "2013",
month = "8",
doi = "10.1111/jsm.12212",
language = "English (US)",
volume = "10",
pages = "2044--2052",
journal = "Journal of Sexual Medicine",
issn = "1743-6095",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions

T2 - Analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies

AU - Porst, Hartmut

AU - Roehrborn, Claus

AU - Secrest, Roberta J.

AU - Esler, Anne

AU - Viktrup, Lars

PY - 2013/8

Y1 - 2013/8

N2 - Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated.

AB - Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated.

KW - Benign Prostatic Hyperplasia

KW - Erectile Dysfunction

KW - Lower Urinary Tract Symptoms

KW - LUTS/BPH

KW - PDE5 Inhibitor

KW - Tadalafil

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U2 - 10.1111/jsm.12212

DO - 10.1111/jsm.12212

M3 - Article

C2 - 23782459

AN - SCOPUS:84881110118

VL - 10

SP - 2044

EP - 2052

JO - Journal of Sexual Medicine

JF - Journal of Sexual Medicine

SN - 1743-6095

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ER -