Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction

Authors

  • C. Stief,

    Corresponding author
    1. Medizinische Hochschule,1 Hannover, Urology Office,2 Hamburg, Germany, Fundación para la Investigación y el Desarrollo en Andrología,3 Madrid, Spain, Bayer Vital GmbH,4 Leverkusen, Germany
      *Professor Dr Christian Stief, Department of Urology, Medizinische Hochschule, Konstanty-Gutschow-Str. 8, D30623 Hannover, Germany
      Tel.: +49 511 532 6672
      Fax: +49 511 532 4941
      Email: stief.christian@mh-hannover.de
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  • 1 H. Porst,

    1. Medizinische Hochschule,1 Hannover, Urology Office,2 Hamburg, Germany, Fundación para la Investigación y el Desarrollo en Andrología,3 Madrid, Spain, Bayer Vital GmbH,4 Leverkusen, Germany
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  • 2 I. Sáenz De Tejada,

    1. Medizinische Hochschule,1 Hannover, Urology Office,2 Hamburg, Germany, Fundación para la Investigación y el Desarrollo en Andrología,3 Madrid, Spain, Bayer Vital GmbH,4 Leverkusen, Germany
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  • 3 E. Ulbrich,

    1. Medizinische Hochschule,1 Hannover, Urology Office,2 Hamburg, Germany, Fundación para la Investigación y el Desarrollo en Andrología,3 Madrid, Spain, Bayer Vital GmbH,4 Leverkusen, Germany
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  • and 4 M. Beneke 4

    1. Medizinische Hochschule,1 Hannover, Urology Office,2 Hamburg, Germany, Fundación para la Investigación y el Desarrollo en Andrología,3 Madrid, Spain, Bayer Vital GmbH,4 Leverkusen, Germany
    Search for more papers by this author

*Professor Dr Christian Stief, Department of Urology, Medizinische Hochschule, Konstanty-Gutschow-Str. 8, D30623 Hannover, Germany
Tel.: +49 511 532 6672
Fax: +49 511 532 4941
Email: stief.christian@mh-hannover.de

Summary

This randomised, double-blind study assessed the long-term efficacy and tolerability of vardenafil 10 and 20 mg in men with erectile dysfunction (ED). A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension. In these men, both doses of vardenafil produced improvement in scores for the ‘erectile function’ Domain of the International Index of Erectile Function, evident from week 4 and maintained through 2 years. Sexual Encounter Profile diary responses indicated that following treatment, penetration was achieved on 92–94% of attempts and erections that lasted long enough for successful intercourse were achieved on 87–89% of attempts. In response to the General Assessment Question, 90–92% of patients reported improved erections with vardenafil. Most treatment-emergent events were mild and transient with no cardiovascular safety concerns. These results support the long-term efficacy, reliability and tolerability of vardenafil 10 and 20 mg in men with ED.

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