Tolerability and safety profile of sildenafil citrate (Viagra®) in Latin American patient populations

Abstract

Safety data from 546 men with erectile dysfunction (ED) enrolled in three double-blind, placebocontrolled studies conducted in distinct regions of Latin America were pooled and analyzed. The most commonly reported adverse events of all causalities associated with sildenafil treatment were headache (19%), flushing (14%), dyspepsia (6%), and nasal congestion (4%), reflecting the inhibitory effects of sildenafil on cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) in the peripheral vasculature, gastroesophageal sphincter, and nasal mucosa. Visual symptoms were reported in 5.5%, reflecting sildenafil's minor inhibitory effects on cGMPspecific PDE6 in the retina. These adverse events were generally transient and mild, and rarely resulted in discontinuation of sildenafil therapy. Thus, in this representative sample of Latin American men with ED, including those with concomitant stable cardiovascular disease, sildenafil treatment was well tolerated with an incident rate of adverse events similar to reports from other patient populations.

Hemodynamic Effects of Sildenafil Citrate (Viagra) on Segmental Branches of Bilateral Renal Arteries

“…Sildenafil citrate acts by inhibition of pathways for nitric oxide degradation. Several studies reported a success rate of 60-85% for treatment of ED with sildenafil citrate [5][6][7][8]. Although sildenafil citrate is used widely for treatment of patients with impotence, effects (positive or negative) of this drug on several organs have not been clearly documented yet.…”

“…Although sildenafil citrate is used widely for treatment of patients with impotence, effects (positive or negative) of this drug on several organs have not been clearly documented yet. Most commonly observed side effects of sildenafil citrate are headache, flushing, dyspepsia, nasal congestion and temporary blindness [5,8]. Following widespread usage of sildenafil citrate, several clinical studies documented that this drug can also be used for treatment of ED in patients with renal dysfunctions [9][10][11].…”