Vardenafil restores erectile function to normal range in men with erectile dysfunction.

Area of Science:

• Urology
• Pharmacology
• Men's Health

Background:

• Erectile dysfunction (ED) significantly impacts men's quality of life.
• Oral phosphodiesterase type 5 (PDE5) inhibitors are a key therapeutic class for ED.
• Restoring normal erectile function is a primary goal of ED treatment.

Purpose of the Study:

• To evaluate the efficacy of vardenafil in restoring normal erectile function in men with ED.
• To assess the proportion of patients achieving normal erectile function (IIEF-EF score ≥26) with vardenafil treatment.
• To analyze treatment outcomes across various patient subgroups based on ED severity, etiology, age, and duration.

Main Methods:

• Two double-blind, placebo-controlled, parallel-group studies were conducted.
• Patients received fixed doses of vardenafil (5, 10, or 20 mg) or placebo for 12 or 26 weeks.
• A retrospective analysis determined the percentage of patients achieving normal erectile function at week 12, with subgroup stratification.

Main Results:

• Vardenafil doses of 5, 10, and 20 mg resulted in 32%, 43%, and 49% of patients returning to normal erectile function, respectively, compared to 10% for placebo (P < 0.0001).
• These improvements were observed across all baseline ED severities, etiologies, age groups (including ≥65 years), and durations of ED (including ≥3 years).
• High success rates (87%-95%) in sexual encounters were reported by patients achieving normal IIEF-EF scores.

Conclusions:

• Vardenafil significantly improves erectile function, enabling a substantial proportion of men with ED to achieve normal IIEF-EF domain scores.
• The treatment demonstrates effectiveness across diverse patient populations, including those with severe or long-standing ED.
• Vardenafil represents an effective therapeutic option for men seeking to restore normal erectile function.