A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea

H. K. Choi, T. Y. Ahn, Je-Jong Kim, S. C. Kim, J. S. Paick, J. K. Suh, H. S. Kim, Y. K. Kim, W. H. Lee, B. H. Oh, C. H. Park, W. S. Ryu, T. G. Chung, S. W. Kim, Du Geon Moon, D. S. Ryu, K. K. Seo, D. K. Kim, D. S. Lee

Research output: Contribution to journalArticle

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Abstract

The efficacy and safety of sildenafil was evaluated in a randomised, double-blind, placebocontrolled, flexible-dose study in Korean men aged 28-78y with erectile dysfunction (ED) of broadspectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and tolerance) (n = 66) or matching placebo (n = 67) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P < 0.0001). Treatment-related adverse events occurred in 56.1% of patients receiving sildenafil and 20.9% receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.

Original languageEnglish
Pages (from-to)80-86
Number of pages7
JournalInternational Journal of Impotence Research
Volume15
Issue number2
DOIs
Publication statusPublished - 2003 Apr 1
Externally publishedYes

Fingerprint

Erectile Dysfunction
Korea
Outpatients
Placebos
Safety
Color Vision
Coitus
Vasodilation
Sexual Behavior
Population
Headache
Sildenafil Citrate
Maintenance

Keywords

  • Efficacy
  • Erectile dysfunction: sildenafil
  • Safety

ASJC Scopus subject areas

  • Urology

Cite this

A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. / Choi, H. K.; Ahn, T. Y.; Kim, Je-Jong; Kim, S. C.; Paick, J. S.; Suh, J. K.; Kim, H. S.; Kim, Y. K.; Lee, W. H.; Oh, B. H.; Park, C. H.; Ryu, W. S.; Chung, T. G.; Kim, S. W.; Moon, Du Geon; Ryu, D. S.; Seo, K. K.; Kim, D. K.; Lee, D. S.

In: International Journal of Impotence Research, Vol. 15, No. 2, 01.04.2003, p. 80-86.

Research output: Contribution to journalArticle

Choi, H. K. ; Ahn, T. Y. ; Kim, Je-Jong ; Kim, S. C. ; Paick, J. S. ; Suh, J. K. ; Kim, H. S. ; Kim, Y. K. ; Lee, W. H. ; Oh, B. H. ; Park, C. H. ; Ryu, W. S. ; Chung, T. G. ; Kim, S. W. ; Moon, Du Geon ; Ryu, D. S. ; Seo, K. K. ; Kim, D. K. ; Lee, D. S. / A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea. In: International Journal of Impotence Research. 2003 ; Vol. 15, No. 2. pp. 80-86.
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abstract = "The efficacy and safety of sildenafil was evaluated in a randomised, double-blind, placebocontrolled, flexible-dose study in Korean men aged 28-78y with erectile dysfunction (ED) of broadspectrum aetiology and more than 6 months duration. A total of 133 patients were randomised at six centres in Korea to receive either sildenafil (50 mg initially, increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and tolerance) (n = 66) or matching placebo (n = 67) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 8 weeks. At the end of this time, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the International Index of Erectile Function (IIEF) scale, (2) the percentage of successful intercourse attempts, and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P < 0.0001). Treatment-related adverse events occurred in 56.1{\%} of patients receiving sildenafil and 20.9{\%} receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache and abnormalities in colour vision (31.8, 22.7 and 6.1{\%} of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western populations.",
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