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Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride.
J Sex Med. 2015 Jan; 12(1):129-38.JS

Abstract

INTRODUCTION

Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described.

AIM

Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED).

METHODS

A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks.

MAIN OUTCOME MEASURES

International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs).

RESULTS

Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders.

CONCLUSIONS

TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.

Authors+Show Affiliations

Instituto H. Ellis, São Paulo, Brazil; Department of Urology, Ipiranga Hospital, São Paulo, Brazil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25353053

Citation

Glina, Sidney, et al. "Sexual Function in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6-month, Randomized, Double-blind, Placebo-controlled Study of Tadalafil Coadministered With Finasteride." The Journal of Sexual Medicine, vol. 12, no. 1, 2015, pp. 129-38.
Glina S, Roehrborn CG, Esen A, et al. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015;12(1):129-38.
Glina, S., Roehrborn, C. G., Esen, A., Plekhanov, A., Sorsaburu, S., Henneges, C., Büttner, H., & Viktrup, L. (2015). Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. The Journal of Sexual Medicine, 12(1), 129-38. https://doi.org/10.1111/jsm.12714
Glina S, et al. Sexual Function in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6-month, Randomized, Double-blind, Placebo-controlled Study of Tadalafil Coadministered With Finasteride. J Sex Med. 2015;12(1):129-38. PubMed PMID: 25353053.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. AU - Glina,Sidney, AU - Roehrborn,Claus G, AU - Esen,Adil, AU - Plekhanov,Alexey, AU - Sorsaburu,Sebastian, AU - Henneges,Carsten, AU - Büttner,Hartwig, AU - Viktrup,Lars, Y1 - 2014/10/29/ PY - 2014/10/30/entrez PY - 2014/10/30/pubmed PY - 2015/6/30/medline KW - 5-Alpha Reductase Inhibitors KW - Benign Prostatic Hyperplasia KW - Ejaculatory Function KW - Erectile Dysfunction KW - Finasteride KW - Lower Urinary Tract Symptoms KW - Orgasmic Function KW - Phosphodiesterase Type 5 Inhibitors KW - Tadalafil SP - 129 EP - 38 JF - The journal of sexual medicine JO - J Sex Med VL - 12 IS - 1 N2 - INTRODUCTION: Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described. AIM: Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED). METHODS: A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs). RESULTS: Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders. CONCLUSIONS: TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/25353053/Sexual_function_in_men_with_lower_urinary_tract_symptoms_and_prostatic_enlargement_secondary_to_benign_prostatic_hyperplasia:_results_of_a_6_month_randomized_double_blind_placebo_controlled_study_of_tadalafil_coadministered_with_finasteride_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)30907-3 DB - PRIME DP - Unbound Medicine ER -