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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.
- Source :
-
BJU international [BJU Int] 2004 Dec; Vol. 94 (9), pp. 1301-9. - Publication Year :
- 2004
-
Abstract
- Objective: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil.<br />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).<br />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.<br />Conclusion: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).
- Subjects :
- Administration, Oral
Adult
Aged
Aged, 80 and over
Double-Blind Method
Humans
Male
Middle Aged
Penile Erection
Prospective Studies
Purines
Sildenafil Citrate
Sulfones
Treatment Outcome
Triazines
Vardenafil Dihydrochloride
Erectile Dysfunction drug therapy
Imidazoles administration & dosage
Phosphodiesterase Inhibitors administration & dosage
Piperazines administration & dosage
Vasodilator Agents administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1464-4096
- Volume :
- 94
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- BJU international
- Publication Type :
- Academic Journal
- Accession number :
- 15610110
- Full Text :
- https://doi.org/10.1111/j.1464-410X.2004.05161.x