PS-5-2 The Daily Therapy With L-Arginine 2500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study

Abstract

To evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2,5 grams in mono- and combination therapy in patients affected by erectile dysfunction (ED). Recruited patients completed at baseline and after treatment the International Index of Erectile Function erectile function domain (IIEF-EF) and Sexual Encounter Profile (SEP) diaries. The survey was randomized into three groups with an equal allocation ratio. Group A received daily L-Arginine 2500 mg; Group B received daily Tadalafil 5 mg and Group C received both daily L-Arginine 2500 mg plus daily Tadalafil 5 mg. The duration of therapy in all three groups was 12 weeks. The main outcome measures were the change from baseline to after treatment in IIEF-EF score and in per-patient percentage of “yes” responses to SEP Question 3. Safety was assessed by evaluating all reported treatment-emergent adverse events (AEs). 300 eligible patients were enrolled and 100 subjects for each group were allocated. Basing on the IIEF-EF score men were divided into three categories: Severe, Moderate and Mild ED. Overall IIEF-EF score increased after therapy in all groups: in Group A from 15 ± 7 to 18,1 ± 9,2; in Group B from 14,8 ± 6,9 to 20,8 ± 7,3 and in Group C from 14,9 ± 7,1 to 22 ± 7,5. In mild ED mean IIEF-EF score increased from 22,1 ± 2,2 to 27,5 ± 2,3 in group A; from 22,1 ± 2,2 to 27,8 ± 2 in group B and from 22,2 ± 2,2 to 29,3 ± 0,9 in group C. We report a total of 11, 53 and 67 cases of AEs in group A, B and C respectively.