Tags

Type your tag names separated by a space and hit enter

Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies.
J Urol 2014; 191(2):405-11JU

Abstract

PURPOSE

Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction.

MATERIALS AND METHODS

Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms.

RESULTS

A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p <0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p <0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p <0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p <0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p <0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement.

CONCLUSIONS

Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction.

Authors+Show Affiliations

University of Western Ontario, London, Ontario, Canada. Electronic address: gebrock@sympatico.ca.Department of Urology, Southern Illinois University, Springfield, Illinois.Department of Urology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas.Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24096120

Citation

Brock, Gerald B., et al. "Direct Effects of Tadalafil On Lower Urinary Tract Symptoms Versus Indirect Effects Mediated Through Erectile Dysfunction Symptom Improvement: Integrated Data Analyses From 4 Placebo Controlled Clinical Studies." The Journal of Urology, vol. 191, no. 2, 2014, pp. 405-11.
Brock GB, McVary KT, Roehrborn CG, et al. Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies. J Urol. 2014;191(2):405-11.
Brock, G. B., McVary, K. T., Roehrborn, C. G., Watts, S., Ni, X., Viktrup, L., ... Donatucci, C. (2014). Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies. The Journal of Urology, 191(2), pp. 405-11. doi:10.1016/j.juro.2013.09.057.
Brock GB, et al. Direct Effects of Tadalafil On Lower Urinary Tract Symptoms Versus Indirect Effects Mediated Through Erectile Dysfunction Symptom Improvement: Integrated Data Analyses From 4 Placebo Controlled Clinical Studies. J Urol. 2014;191(2):405-11. PubMed PMID: 24096120.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies. AU - Brock,Gerald B, AU - McVary,Kevin T, AU - Roehrborn,Claus G, AU - Watts,Steven, AU - Ni,Xiao, AU - Viktrup,Lars, AU - Wong,David G, AU - Donatucci,Craig, Y1 - 2013/10/01/ PY - 2013/09/17/accepted PY - 2013/10/8/entrez PY - 2013/10/8/pubmed PY - 2014/4/15/medline KW - BPH KW - ED KW - LUTS KW - PDE5 KW - benign prostatic hyperplasia KW - erectile dysfunction KW - lower urinary tract symptoms KW - phosphodiesterase 5 inhibitors KW - phosphodiesterase type 5 KW - prostatic hyperplasia KW - tadalafil SP - 405 EP - 11 JF - The Journal of urology JO - J. Urol. VL - 191 IS - 2 N2 - PURPOSE: Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction. MATERIALS AND METHODS: Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms. RESULTS: A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p <0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p <0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p <0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p <0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p <0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement. CONCLUSIONS: Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/24096120/Direct_effects_of_tadalafil_on_lower_urinary_tract_symptoms_versus_indirect_effects_mediated_through_erectile_dysfunction_symptom_improvement:_integrated_data_analyses_from_4_placebo_controlled_clinical_studies_ L2 - https://www.jurology.com/doi/full/10.1016/j.juro.2013.09.057?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -