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Subject Area

Otorhinolaryngology

Article Type

Original Study

Abstract

Objective To evaluate the post-marketing efficacy of avanafil 100 mg, safety, and the probable adverse events in the treatment of Egyptian men with erectile dysfunction (ED). Background ED is one of the most common sexual disorders due to organic, psychogenic, or mixed etiologies. Its prevalence ranges from 6 to 64% increasing with age. Avanafil is a highly selective and potent second-generation phosphodiesterase 5 inhibitor. Patients and methods This was a double-blind, placebo-controlled, crossover study including 26 patients with mild to severe ED using the International Index of Erectile Function-Erectile Function. Patients received avanafil 100 mg or placebo for 6 weeks each, with a 2-week washout period in between. It was taken 30 min precoital on-demand twice weekly. Follow-up was at the end of the third and sixth week. Results Avanafil 100 mg significantly increased the mean IEEF-EF score when compared with the baseline (P < 0.001) and when compared with the placebo (P = 0.005), while placebo was not significant (P > 0.05). On use of avanafil 100 mg, 45% of patients became normal (no ED, score >25) by the end of the sixth week; 40% showed different grades of improvement; and 15% showed no improvement. The onset of action of avanafil was within 30 min in 85% of responders. The reported adverse events were nasal congestion, headache, facial flushing, tingling of hands and/or feet, heartburn, and diarrhea. Conclusion Avanafil 100 mg has a rapid onset of action, is efficient, and a tolerable drug for the treatment of ED.

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