Purpose: To evaluate the efficacy and safety of sildenafil in orodispersable tablets of 50 mg vs. placebo in men with erectile dysfunction (ED). Methods: A blind, comparative, placebo controlled, randomized study was developed in 106 patients with ED. They randomly received sildenafil orodispersable 50 mg (Group I) or placebo (Group II) 3 times per week, 1 hour before sexual activity, during 4 weeks. The efficacy was evaluated by IIEF-5 and the adverse events (AE) by poll. Results: After 4 weeks a percentage improvement of the ED was observed in Group I patients 44% of whom became without ED vs. 2% of Group II, with an additional statistical significant improvement evidenced respect to the placebo in the IIEF-5 score from 13.7 ± 4.9 to 19.9 ± 4.4 vs. 13.1 ± 4.0 to 17.8 ± 4.9 in the placebo group, Confidence Interval (CI95%): 19.90 vs. 13.98, respectively, p Conclusions: Sildenafil was superior to placebo, substantially improved the IIEF-5 scores, showing a statistical significant therapeutic response in the ED treatment and it was safe and well tolerated.
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