Tags

Type your tag names separated by a space and hit enter

The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men.
Eur Urol. 2004 May; 45(5):634-41; discussion 641.EU

Abstract

BACKGROUND

In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed.

METHODS

In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions.

RESULTS

The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient.

CONCLUSION

In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.

Authors+Show Affiliations

Hatzichristou D
Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, 77 Mitropoleos str., 546 22 Thessaloniki, Greece. hatzichr@med.auth.gr
Montorsi F
No affiliation info available
Buvat J
No affiliation info available
Laferriere N
No affiliation info available
Bandel TJ
No affiliation info available
Porst H
No affiliation info available
European Vardenafil Study Group
No affiliation info available

MeSH

Erectile DysfunctionEuropeHumansImidazolesMaleMiddle AgedPhosphodiesterase InhibitorsPiperazinesProspective StudiesSulfonesSurveys and QuestionnairesTriazinesVardenafil Dihydrochloride

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15082207

Citation

Hatzichristou, Dimitrios, et al. "The Efficacy and Safety of Flexible-dose Vardenafil (levitra) in a Broad Population of European Men." European Urology, vol. 45, no. 5, 2004, pp. 634-41; discussion 641.
Hatzichristou D, Montorsi F, Buvat J, et al. The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men. Eur Urol. 2004;45(5):634-41; discussion 641.
Hatzichristou, D., Montorsi, F., Buvat, J., Laferriere, N., Bandel, T. J., & Porst, H. (2004). The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men. European Urology, 45(5), 634-41; discussion 641.
Hatzichristou D, et al. The Efficacy and Safety of Flexible-dose Vardenafil (levitra) in a Broad Population of European Men. Eur Urol. 2004;45(5):634-41; discussion 641. PubMed PMID: 15082207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men. AU - Hatzichristou,Dimitrios, AU - Montorsi,Francesco, AU - Buvat,Jacques, AU - Laferriere,Nicole, AU - Bandel,Tiemo-Joerg, AU - Porst,Hartmut, AU - ,, PY - 2004/01/26/accepted PY - 2004/4/15/pubmed PY - 2004/8/31/medline PY - 2004/4/15/entrez SP - 634-41; discussion 641 JF - European urology JO - Eur Urol VL - 45 IS - 5 N2 - BACKGROUND: In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed. METHODS: In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions. RESULTS: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient. CONCLUSION: In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED. SN - 0302-2838 UR - https://www.unboundmedicine.com/medline/citation/15082207/The_efficacy_and_safety_of_flexible_dose_vardenafil__levitra__in_a_broad_population_of_European_men_ DB - PRIME DP - Unbound Medicine ER -