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Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care

International Journal of Impotence Research volume 19, pages 393–397 (2007)Cite this article

Abstract

To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were ‘very satisfied’ or ‘satisfied’ with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.

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Acknowledgements

This study is part of a re-examination study of vardenafil, which is supported by a grant from Bayer Korea.

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Authors and Affiliations

  1. Department of Family Medicine, Catholic U niversity College of Medicine, Uijeongbu, Korea

    C M Kim

  2. Department of Family Medicine, University of Ulsan College of Medicine, Seoul, Korea

    Y S Kim & S Sunwoo

  3. Department of Family Medicine, Seoul National University College of Medicine, Seoul, Korea

    B Cho

  4. Dr Rho's Family Medicine Clinic, Seoul, Korea

    M Rho

  5. Inje Institute of Advanced Studies, Seoul, Korea

    Y J Yang

  6. Department of Family Medicine, Medical College of Inje University, Goyang, Korea

    C H Kim

  7. Department of Family Medicine, College of Medicine, Sungkyunkwan University, Seoul, Korea

    H C Shin

  8. Department of Family Medicine, College of Medicine, Pusan National University, Pusan, Korea

    S Y Lee

  9. Department of Family Medicine, College of Medicine, Keimyung University, Daegu, Korea

    D H Kim

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  1. C M Kim
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and Korea Post-Marketing Surveillance Research Group

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Correspondence to Y S Kim.

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Kim, C., Kim, Y., Sunwoo, S. et al. Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care. Int J Impot Res 19, 393–397 (2007). https://doi.org/10.1038/sj.ijir.3901544

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  • DOI: https://doi.org/10.1038/sj.ijir.3901544

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