Author(s)

Maria Antonieta Annunziato^1*, Di Capua Teodoro², Dieguez Vicente², Ledos Luis², Koury Mufid²

¹Department of Internal Medicine, Medical Attention Center, BANDESIR, Caracas, Venezuela.
²Department of Urology, Domingo Luciani Hospital, Caracas, Venezuela.

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 < 0.001. Regarding the basal value, a total increment of the IIEF-5 was observed, at the end of the 4 weeks treatment of 60% in Group I vs. 10% in Group II. In Group I was evidenced an statistical significant improvement of the IIEF-5 in each of the 5 questions at the end of the 4 weeks, specially in questions 3, 4, and 5 related to keeping the erection and satisfaction (p < 0.0001). The AE were mild, transient and could be tolerated. No patient dropped out because AE. 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.

Erectile Dysfunction, Sildenafil, Orodispersable Tablets

Annunziato, M. , Teodoro, D. , Vicente, D. , Luis, L. and Mufid, K. (2018) Efficacy and Safety Evaluation of Sildenafil Citrate in the Form of 50 mg Orodispersible Tablets Controlled by Placebo. Case Reports in Clinical Medicine, 7, 249-258. doi: 10.4236/crcm.2018.73023.