Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men

A multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial

Jae Seung Paick, Hyung Ki Choi, Sae Chul Kim, Tai Young Ahn, Je-Jong Kim, Jong Kwan Park, Kwang Sung Park, Sung Won Lee, Sae Woong Kim, Kwanjin Park, Hyonggi Jung, Nam Cheol Park

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE51), in Korean men with erectile dysfunction (ED). Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. Results: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P < 0.05). Of the 89 patients in the treatment arm, 36 (42.3 %) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.

Original languageEnglish
Pages (from-to)791-798
Number of pages8
JournalAsian Journal of Andrology
Volume10
Issue number5
DOIs
Publication statusPublished - 2008 Aug 29

Fingerprint

Erectile Dysfunction
Placebos
Clinical Trials
Safety
Therapeutics
Phosphodiesterase 5 Inhibitors
Vital Signs
Dizziness
Korea
Sexual Behavior
Headache
2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride
Arm
Population

Keywords

  • Erectile dysfunction
  • Phosphodiesterase
  • Sildenafil citrate

ASJC Scopus subject areas

  • Urology

Cite this

Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men : A multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial. / Paick, Jae Seung; Choi, Hyung Ki; Kim, Sae Chul; Ahn, Tai Young; Kim, Je-Jong; Park, Jong Kwan; Park, Kwang Sung; Lee, Sung Won; Kim, Sae Woong; Park, Kwanjin; Jung, Hyonggi; Park, Nam Cheol.

In: Asian Journal of Andrology, Vol. 10, No. 5, 29.08.2008, p. 791-798.

Research output: Contribution to journalArticle

Paick, Jae Seung ; Choi, Hyung Ki ; Kim, Sae Chul ; Ahn, Tai Young ; Kim, Je-Jong ; Park, Jong Kwan ; Park, Kwang Sung ; Lee, Sung Won ; Kim, Sae Woong ; Park, Kwanjin ; Jung, Hyonggi ; Park, Nam Cheol. / Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men : A multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial. In: Asian Journal of Andrology. 2008 ; Vol. 10, No. 5. pp. 791-798.
@article{d63de52e6ccb47718417eb4d77ede79f,
title = "Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men: A multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial",
abstract = "Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE51), in Korean men with erectile dysfunction (ED). Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. Results: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P < 0.05). Of the 89 patients in the treatment arm, 36 (42.3 {\%}) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9{\%}, 7.6{\%}, 2.5{\%} and 2.5{\%}, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.",
keywords = "Erectile dysfunction, Phosphodiesterase, Sildenafil citrate",
author = "Paick, {Jae Seung} and Choi, {Hyung Ki} and Kim, {Sae Chul} and Ahn, {Tai Young} and Je-Jong Kim and Park, {Jong Kwan} and Park, {Kwang Sung} and Lee, {Sung Won} and Kim, {Sae Woong} and Kwanjin Park and Hyonggi Jung and Park, {Nam Cheol}",
year = "2008",
month = "8",
day = "29",
doi = "10.1111/j.1745-7262.2008.00422.x",
language = "English",
volume = "10",
pages = "791--798",
journal = "Asian Journal of Andrology",
issn = "1008-682X",
publisher = "Nature Publishing Group",
number = "5",

}

TY - JOUR

T1 - Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men

T2 - A multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial

AU - Paick, Jae Seung

AU - Choi, Hyung Ki

AU - Kim, Sae Chul

AU - Ahn, Tai Young

AU - Kim, Je-Jong

AU - Park, Jong Kwan

AU - Park, Kwang Sung

AU - Lee, Sung Won

AU - Kim, Sae Woong

AU - Park, Kwanjin

AU - Jung, Hyonggi

AU - Park, Nam Cheol

PY - 2008/8/29

Y1 - 2008/8/29

N2 - Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE51), in Korean men with erectile dysfunction (ED). Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. Results: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P < 0.05). Of the 89 patients in the treatment arm, 36 (42.3 %) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.

AB - Aim: To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE51), in Korean men with erectile dysfunction (ED). Methods: A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs. Results: At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P < 0.05). Of the 89 patients in the treatment arm, 36 (42.3 %) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion: The results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.

KW - Erectile dysfunction

KW - Phosphodiesterase

KW - Sildenafil citrate

UR - http://www.scopus.com/inward/record.url?scp=50149099783&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=50149099783&partnerID=8YFLogxK

U2 - 10.1111/j.1745-7262.2008.00422.x

DO - 10.1111/j.1745-7262.2008.00422.x

M3 - Article

VL - 10

SP - 791

EP - 798

JO - Asian Journal of Andrology

JF - Asian Journal of Andrology

SN - 1008-682X

IS - 5

ER -