Abstract

Tuesday 28 August 2012: 02:00 pm - 03:30 pm @ Chicago Ballroom VIII
Podium 6: ED: medical therapy
Chairs: Edgardo Becher, MD, PhD - Argentina & Alan Shindel, MD - USA

03:10 pm - 03:20 pm
Tadalafil Once Daily Following PRN Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function (#038)
E.D. Kim - Division of Urology, Department of Surgery, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA

Objective: To determine if men who did not achieve normal erectile function (IIEF-EF domain score ?26) with the maximum dose of a PRN PDE5 inhibitor have: a) a significantly greater probability of return to normal erectile function; b) significant improvement in the change from baseline in IIEF-EF domain score and; c) significant improvement from baseline in the percentage of successful intercourse as measured by Sexual Encounter Profile question 3 (SEP3), when treated with tadalafil once daily compared to placebo. Material and Methods: Two identical double-blind, randomized, placebo-controlled studies were conducted in which men following a 1 month maximum dose PRN PDE5 treatment and 1 month nondrug lead periods were randomized to once daily therapy with tadalafil 2.5 mg to 5 mg, tadalafil 5 mg, or placebo for 12 weeks. Combined results of the 2 studies are reported. Results: In men with ED (n = 590), average age of 58 years, erectile function was significantly improved with tadalafil once daily compared to placebo. A significantly higher percentage of men treated with tadalafil 2.5 to 5 mg (39%) and tadalafil 5 mg (40%) had an IIEF-EF domain score ?26 at endpoint compared to placebo (12%) (both p < .001). An 8-point improvement from a baseline IIEF-EF domain score of 14 was observed for both tadalafil groups, compared to 2 points for the placebo (p < .001). Significant improvement was also seen in change from baseline in SEP3 with tadalafil 2.5 to 5 mg of 38% (endpoint 68) and tadalafil 5 mg of 40% (endpoint 69) compared to 12% (endpoint 43) for placebo (both p < .001). Tadalafil was generally well tolerated and adverse reactions observed were consistent with previous reports of tadalafil once daily. Conclusions: Approximately 40% of men who did not achieve normal IIEF-EF domain score when using the maximum dose of a PRN PDE5I were able achieve normal scores when treated with tadalafil once daily. Treatment with tadalafil once daily may be a viable option for men with ED that could help restore normal erectile function.

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Abstract provided for informational purposes only. Cite this abstract as: (2012), PROCEEDINGS OF THE WORLD MEETING ON SEXUAL MEDICINE, CHICAGO, USA, AUGUST 26-30 2012. Journal of Sexual Medicine, 9: 183-298. doi: 10.1111/j.1743-6109.2012.02863.x. A copy of these proceedings can be found in your conference bag.