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Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial.
BJU Int. 2004 Dec; 94(9):1301-9.BI

Abstract

OBJECTIVE

To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil.

PATIENTS AND METHODS

A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ).

RESULTS

There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile.

CONCLUSION

Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).

Authors+Show Affiliations

Carson CC
School of Medicine, University of North Carolina, Chapel Hill, NC 27599-7235, USA. culley_carson@med.unc.edu
Hatzichristou DG
No affiliation info available
Carrier S
No affiliation info available
Lording D
No affiliation info available
Lyngdorf P
No affiliation info available
Aliotta P
No affiliation info available
Auerbach S
No affiliation info available
Murdock M
No affiliation info available
Wilkins HJ
No affiliation info available
McBride TA
No affiliation info available
Colopy MW
No affiliation info available
Patient Response with Vardenafil in Slidenafil Non-Responders (PROVEN) Study Group
No affiliation info available

MeSH

Administration, OralAdultAgedAged, 80 and overDouble-Blind MethodErectile DysfunctionHumansImidazolesMaleMiddle AgedPenile ErectionPhosphodiesterase InhibitorsPiperazinesProspective StudiesPurinesSildenafil CitrateSulfonesTreatment OutcomeTriazinesVardenafil DihydrochlorideVasodilator Agents

Pub Type(s)

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

Language

eng

PubMed ID

15610110

Citation

Carson, Culley C., et al. "Erectile Response With Vardenafil in Sildenafil Nonresponders: a Multicentre, Double-blind, 12-week, Flexible-dose, Placebo-controlled Erectile Dysfunction Clinical Trial." BJU International, vol. 94, no. 9, 2004, pp. 1301-9.
Carson CC, Hatzichristou DG, Carrier S, et al. Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial. BJU Int. 2004;94(9):1301-9.
Carson, C. C., Hatzichristou, D. G., Carrier, S., Lording, D., Lyngdorf, P., Aliotta, P., Auerbach, S., Murdock, M., Wilkins, H. J., McBride, T. A., & Colopy, M. W. (2004). Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial. BJU International, 94(9), 1301-9.
Carson CC, et al. Erectile Response With Vardenafil in Sildenafil Nonresponders: a Multicentre, Double-blind, 12-week, Flexible-dose, Placebo-controlled Erectile Dysfunction Clinical Trial. BJU Int. 2004;94(9):1301-9. PubMed PMID: 15610110.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial. AU - Carson,Culley C, AU - Hatzichristou,Dimitrios G, AU - Carrier,Serge, AU - Lording,Douglas, AU - Lyngdorf,Peter, AU - Aliotta,Philip, AU - Auerbach,Stephen, AU - Murdock,Myron, AU - Wilkins,H Jeffrey, AU - McBride,Trish A, AU - Colopy,Michael W, AU - ,, PY - 2004/12/22/pubmed PY - 2005/2/3/medline PY - 2004/12/22/entrez SP - 1301 EP - 9 JF - BJU international JO - BJU Int VL - 94 IS - 9 N2 - OBJECTIVE: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile. CONCLUSION: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history). SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/15610110/Erectile_response_with_vardenafil_in_sildenafil_nonresponders:_a_multicentre_double_blind_12_week_flexible_dose_placebo_controlled_erectile_dysfunction_clinical_trial_ DB - PRIME DP - Unbound Medicine ER -