Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan

International Journal of Urology : Official Journal of the Japanese Urological Association
Koichi NagaoVardenafil (Levitra) Clinical Trial Group

Abstract

Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections ...Continue Reading

References

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Citations

Feb 10, 2009·Nihon Hinyōkika Gakkai zasshi. The japanese journal of urology·Amano ToshiyasuUNKNOWN Nagano City ED Research Group
May 15, 2007·The Journal of Sexual Medicine·Kuang-Kuo Chen On Behalf Of The Vardenafil Study Group
Jan 23, 2010·The Journal of Sexual Medicine·Ian EardleySung Won Lee
Jul 27, 2005·BJU International·Culley C Carson, Tom F Lue
Jul 23, 2008·International Journal of Urology : Official Journal of the Japanese Urological Association·Yasusuke KimotoUNKNOWN Japanese Society for Sexual Medicine
May 3, 2007·Expert Opinion on Pharmacotherapy·Thorsten Reffelmann, Robert A Kloner
Jun 7, 2005·Expert Opinion on Drug Safety·Thorsten Reffelmann, Robert A Kloner
Nov 7, 2006·International Journal of Urology : Official Journal of the Japanese Urological Association·Yasusuke KimotoToshikazu Otani
Aug 15, 2006·International Journal of Urology : Official Journal of the Japanese Urological Association·Nobuhisa IshiiSadao Kamidono

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