Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial

Chen Zhao; Sae Woong Kim; Dae Yul Yang; Je Jong Kim; Nam Cheol Park; Sung Won Lee; Jae Seung Paick; Tai Young Ahn; Kweon Sik Min; Kwangsung Park; Jong Kwan Park

doi:10.1016/j.eururo.2011.03.025

Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial

Chen Zhao
, Sae Woong Kim
, Dae Yul Yang
, Je Jong Kim
, Nam Cheol Park
, Sung Won Lee
, Jae Seung Paick
, Tai Young Ahn
, Kweon Sik Min
, Kwangsung Park
, Jong Kwan Park

Department of Urology

Research output: Contribution to journal › Article › peer-review

48 Scopus citations

Abstract

Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.

Original language	English
Pages (from-to)	380-387
Number of pages	8
Journal	European Urology
Volume	60
Issue number	2
DOIs	https://doi.org/10.1016/j.eururo.2011.03.025
State	Published - Aug 2011

Bibliographical note

Funding Information:
Udenafil in doses of 50 and 75 mg administered once daily for 12 wk significantly improved erectile function among ED patients. The daily administration of udenafil (50 mg) is a promising treatment option for patients with ED. Author contributions: Jong Kwan Park had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Chen Zhao, Sae Woong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Acquisition of data: Chen Zhao, Jong Kwan Park. Analysis and interpretation of data: Chen Zhao, Jong Kwan Park. Drafting of the manuscript: Chen Zhao, Jong Kwan Park. Critical revision of the manuscript for important intellectual content: Jong Kwan Park. Statistical analysis: Chen Zhao. Obtaining funding: Chen Zhao, Sae Wong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Administrative, technical, or material support: Chen Zhao, Jong Kwan Park. Supervision: Jong Kwan Park. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: The authors received a grant from Dong-A Pharmaceutical Company (Study No.: DA8159_EDD_II). Funding/Support and role of the sponsor: Collection of the data and preparation.

Keywords

Clinical study
Erectile dysfunction (ED)
Once-daily dosing
Phosphodiesterase type 5 inhibitor (PDE5-I)
Udenafil

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10.1016/j.eururo.2011.03.025

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Zhao, C., Kim, S. W., Yang, D. Y., Kim, J. J., Park, N. C., Lee, S. W., Paick, J. S., Ahn, T. Y., Min, K. S., Park, K., & Park, J. K. (2011). Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial. European Urology, 60(2), 380-387. https://doi.org/10.1016/j.eururo.2011.03.025

@article{326c809103f9436f87a31576c5f56022,

title = "Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial",

abstract = "Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.",

keywords = "Clinical study, Erectile dysfunction (ED), Once-daily dosing, Phosphodiesterase type 5 inhibitor (PDE5-I), Udenafil",

author = "Chen Zhao and Kim, \{Sae Woong\} and Yang, \{Dae Yul\} and Kim, \{Je Jong\} and Park, \{Nam Cheol\} and Lee, \{Sung Won\} and Paick, \{Jae Seung\} and Ahn, \{Tai Young\} and Min, \{Kweon Sik\} and Kwangsung Park and Park, \{Jong Kwan\}",

note = "Funding Information: Udenafil in doses of 50 and 75 mg administered once daily for 12 wk significantly improved erectile function among ED patients. The daily administration of udenafil (50 mg) is a promising treatment option for patients with ED. Author contributions: Jong Kwan Park had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Chen Zhao, Sae Woong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Acquisition of data: Chen Zhao, Jong Kwan Park. Analysis and interpretation of data: Chen Zhao, Jong Kwan Park. Drafting of the manuscript: Chen Zhao, Jong Kwan Park. Critical revision of the manuscript for important intellectual content: Jong Kwan Park. Statistical analysis: Chen Zhao. Obtaining funding: Chen Zhao, Sae Wong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Administrative, technical, or material support: Chen Zhao, Jong Kwan Park. Supervision: Jong Kwan Park. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: The authors received a grant from Dong-A Pharmaceutical Company (Study No.: DA8159\_EDD\_II). Funding/Support and role of the sponsor: Collection of the data and preparation. ",

year = "2011",

month = aug,

doi = "10.1016/j.eururo.2011.03.025",

language = "English",

volume = "60",

pages = "380--387",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier B.V.",

number = "2",

}

Zhao, C, Kim, SW, Yang, DY, Kim, JJ, Park, NC, Lee, SW, Paick, JS, Ahn, TY, Min, KS, Park, K & Park, JK 2011, 'Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial', European Urology, vol. 60, no. 2, pp. 380-387. https://doi.org/10.1016/j.eururo.2011.03.025

TY - JOUR

T1 - Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction

T2 - Results of a multicenter, randomized, double-blind, placebo-controlled trial

AU - Zhao, Chen

AU - Kim, Sae Woong

AU - Yang, Dae Yul

AU - Kim, Je Jong

AU - Park, Nam Cheol

AU - Lee, Sung Won

AU - Paick, Jae Seung

AU - Ahn, Tai Young

AU - Min, Kweon Sik

AU - Park, Kwangsung

AU - Park, Jong Kwan

N1 - Funding Information: Udenafil in doses of 50 and 75 mg administered once daily for 12 wk significantly improved erectile function among ED patients. The daily administration of udenafil (50 mg) is a promising treatment option for patients with ED. Author contributions: Jong Kwan Park had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Chen Zhao, Sae Woong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Acquisition of data: Chen Zhao, Jong Kwan Park. Analysis and interpretation of data: Chen Zhao, Jong Kwan Park. Drafting of the manuscript: Chen Zhao, Jong Kwan Park. Critical revision of the manuscript for important intellectual content: Jong Kwan Park. Statistical analysis: Chen Zhao. Obtaining funding: Chen Zhao, Sae Wong Kim, Dae Yul Yang, Je Jong Kim, Nam Cheol Park, Sung Won Lee, Jae Seung Paick, Tai Young Ahn, Kweon Sik Min, Kwangsung Park, Jong Kwan Park. Administrative, technical, or material support: Chen Zhao, Jong Kwan Park. Supervision: Jong Kwan Park. Other (specify): None. Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: The authors received a grant from Dong-A Pharmaceutical Company (Study No.: DA8159_EDD_II). Funding/Support and role of the sponsor: Collection of the data and preparation.

PY - 2011/8

Y1 - 2011/8

N2 - Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.

AB - Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.

KW - Clinical study

KW - Erectile dysfunction (ED)

KW - Once-daily dosing

KW - Phosphodiesterase type 5 inhibitor (PDE5-I)

KW - Udenafil

UR - https://www.scopus.com/pages/publications/79959568696

U2 - 10.1016/j.eururo.2011.03.025

DO - 10.1016/j.eururo.2011.03.025

M3 - Article

C2 - 21458153

AN - SCOPUS:79959568696

SN - 0302-2838

VL - 60

SP - 380

EP - 387

JO - European Urology

JF - European Urology

IS - 2

ER -

Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial

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Keywords

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