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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

International Journal of Impotence Research volume 15, pages 80–86 (2003)Cite this article

Abstract

The efficacy and safety of sildenafil was evaluated in a randomiSed, double-blind, placebo-controlled, flexible-dose study in Korean men aged 28–78 y with erectile dysfunction (ED) of broad-spectrum 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 l00 mg or decreased to 25 mg depending on efficacy and tolerance) (n=66) or matching placebo (n=67) taken on an ‘as needed’ basis l 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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Acknowledgements

This paper is supported by grants from Pfizer.

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Authors and Affiliations

  1. Department of Urology, Yonsei University Hospital, Korea

    H K Choi & W H Lee

  2. Department of Urology, Ulsan University Hospital, Korea

    T Y Ahn & T G Chung

  3. Department of Urology, Korea University Hospital, Korea

    J J Kim & D G Moon

  4. Department of Urology, Chung-ang University Hospital, Korea

    S C Kim & K K Seo

  5. Department of Urology, Seoul University Hospital, Korea

    J S Paick & S W Kim

  6. Department of Urology, Inha University Hospital, Korea

    J K Suh & D S Ryu

  7. Department of Medicine, Yonsei University Hospital, Korea

    H S Kim

  8. Department of Medicine, Korea University Hospital, Korea

    Y K Kim

  9. Department of Medicine, Inha University Hospital, Korea

    W H Lee

  10. Department of Medicine, Seoul University Hospital, Korea

    B H Oh

  11. Department of Medicine, Ulsan University Hospital, Korea

    C H Park

  12. Department of Medicine, Chung-ang University Hospital, Korea

    W S Ryu

  13. Department of Biostatistics, Yonsei University, College of Medicine, Korea

    D K Kim

  14. Pfizer Pharmaceuticals Korea Ltd., Korea

    D S Lee

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  1. H K Choi
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Correspondence to H K Choi.

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Choi, H., Ahn, T., Kim, J. et al. 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. Int J Impot Res 15, 80–86 (2003). https://doi.org/10.1038/sj.ijir.3900944

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  • DOI: https://doi.org/10.1038/sj.ijir.3900944

Keywords

  • erectile dysfunction: sildenafil
  • efficacy
  • safety

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