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Vardenafil provides reliable efficacy over time in men with erectile dysfunction
Francesco Montorsi1, Wayne J G Hellstrom, Luc Valiquette
1Instituto San Raffaele, Milan, Italy.
Urology
|December 15, 2004
Summary
Vardenafil reliably improves erectile function (ED) in men, showing significant success rates for penetration and satisfaction within 12 weeks. This oral treatment is effective for various ED severities.
Area of Science:
- Urology
- Pharmacology
- Clinical Trials
Background:
- Erectile dysfunction (ED) affects a significant number of men, impacting sexual health and quality of life.
- Oral phosphodiesterase type 5 inhibitors are a common treatment modality for ED.
Purpose of the Study:
- To assess the reliability and efficacy of vardenafil in treating erectile dysfunction over a 12-week period.
- To evaluate patient-reported outcomes including penetration, erection maintenance, and satisfaction.
Main Methods:
- Retrospective analysis of two Phase III randomized, double-blind, placebo-controlled trials.
- 1650 men with ED received vardenafil (5 mg, 10 mg, 20 mg) or placebo on demand.
- Efficacy assessed using Sexual Encounter Profile (SEP) diaries for penetration (SEP-2) and maintenance (SEP-3).
Main Results:
- Vardenafil significantly improved success rates for vaginal penetration (SEP-2) and erection maintenance (SEP-3) compared to placebo.
- Higher doses of vardenafil showed greater efficacy, with success rates up to 91% for penetration and 84% for maintenance.
- Patient satisfaction with erection hardness and overall sexual experience also significantly improved with vardenafil.
Conclusions:
- Vardenafil demonstrates reliable efficacy in improving key erectile function parameters for men with ED.
- The findings support vardenafil as an effective oral treatment option for ongoing ED management.
- Adverse events were generally mild to moderate, including headache, flushing, and rhinitis.