NE-AUA 2006 Annual Meeting, September 28 - 30, 2006, The Westin Hotel & Rhode Island Convention Center Providence, Rhode Island
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Realise Study: Real Life Safety and Tolerability of Vardenafil in the Treatment of Men with Erectile Dysfunction
Eric Cheng, MD, MPA.
SUNY in Brooklyn, Brooklyn, NY,

Real Life Safety and Efficacy of Vardenafil in the Treatment of Erectile Dysfunction_Results From 30,010 US Patients
Eric Cheng, MD
Corresponding Author: Eric Cheng, MD, 3309 Church Ave # 2, Brooklyn, NY 11203. Tel: 718-856-3100; Fax: 718-856-6561; E-mail: pi.MD
Background: Clinical trials show that vardenafil produces effective and satisfactory first-dose success rates and reliability for erection and intercourse in men with erectile dysfunction (ED).
Aim:This study was conducted to evaluate the real-life efficacy, safety, and acceptance of vardenafil in men with ED.
Methods: This open-label, prospective study was conducted in 6740 US centers. There was an initial visit and 1 or 2 follow-up visits within a 2-month period of the first vardenafil dose. Vardenafil was administered in 5 mg to 20 mg doses.
Main Outcome Measures: Efficacy variables included first-dose success rates for vaginal penetration, maintenance of erection and satisfaction based on physician and patient assessments. Safety was assessed by adverse events (AEs).
Results:A total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile function in78% of men, with 75% rating overall efficacy as “satisfying” or “very satisfying.” The overall rates of successful penetration and maintenance with vardenafil following the first dose were 78% and 68%, respectively. For men with mild and moderate ED, first-dose success rates for penetration were 89% and 82%, respectively, and for maintenance, 82% and 71%, respectively. First-dose penetration and maintenance of erection rates were 76% and 66%, respectively for men with self-reported hypertension, and 70% and 60%, respectively for men with diabetes mellitus. At study end, 67% of patients preferred to continue using vardenafil. The most frequently reported AEs were headache (4%) and flushing (2%). Vardenafil was well tolerated, with a “satisfied/very satisfied” tolerability rating in 75% of cases as assessed by the physician.
Conclusions:This observational study demonstrated the tolerability and efficacy of vardenafil in men with ED and comorbidities. Vardenafil provided a high rate of first-dose intercourse success and a favorable safety profile in patients with and without comorbid disease.

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