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Vardenafil Improves Erectile Function in Men with Erectile Dysfunction Irrespective of Disease Severity and Disease Classification

2004; Elsevier BV; Volume: 1; Issue: 3 Linguagem: Inglês

10.1111/j.1743-6109.04043.x

1743-6109

Craig F. Donatucci, Ian Eardley, Irène Buvat, Marc Gittelman, Phillip Kell, Thom Segerson, Martin Homering, Francesco Montorsi, Roger De Bruyne, Georges Declercq, Dirk Vanderscheuren, Francis Duyck, Benny Verheyden, Eric Wespes, Thomas Gerstenberg, Overlæge Peter Lyngdorf, François Giuliano, B. Cuzin, A Leriche, P. Bondil, Pierre Costa, Thierry Lebrét, Emmanuel Blanc, Olivier Lan, Robert Porto, K M Desai, Wilbert Dinsmore, Roger Kirby, M. J. SPEAKMAN, David Ralph, Geoffrey Hackett, Vincenzo Mirone, Francesco Paolo Selvaggi, G. Carmignani, Francesco Francesca, Fabrizio Fabris, Enrico Pisani, G. Breda, E. Belgrano, Gaetano Frajese, Arcangelo Pagliarulo, Vincenzo Gentile, Vincenzo Bonifacio, R. F. Kropman, E.J.H. Meuleman, Henk Asscheman, K Krajka, Wen‐Chien Ko, Christer Dahlstrand, Peter Ekman, Björn Lundquist, Randall P. Abele, Gerald L. Andriole, Stephen M. Auerbach, Jack Barkin, Winston Barzell, Donald Bergner, Richard Casey, Stacy J. Childs, Selwyn Cohen, David Cook, Jeoffrey Deeths, Mostafa Elhilali, Pamela Ellsworth, Howard B. Epstein, Robert Feldman, Louis Fields, Roger Keith Fincher, William Iii Fitch, Jenelle E. Foote, Jeffrey Frankel, Harold A. Fuselier, Larry Gilderman, Evan R. Goldfischer, James E. Gottesman, Fred E. Govier, Michael Greenspan, Wayne J.G. Hellstrom, Charles B. Herring, Gary Karlin, Joel M. Kaufman, Robert J. Krane, John N. Krieger, Alan H. Lau, W Leitner, Joel Lilly, Jack D. Lubensky, Nizamuddin Maruf, K. Matthews, Kevin T. McVary, Andrew McCullough, Arnold Melman, William B. Monnig, Craig Niederberger, Harin Padma-Nathan, Allan Patrick, Jon Lee Peterson, Peter Pommerville, V. Gary Price,

Marriage and Sexual Relationships

ABSTRACT Background Vardenafil (Levitra®) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification. Methods Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ). Results Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37–41% of patients had severe ED, 30–34% moderate, 22% mild-to-moderate and 6–8% mild ED. At baseline, 46–51% of patients were considered to have an organic cause for ED, 13–16% psychogenic ED, and 36–38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class. Conclusion Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.