Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study.Int J Impot Res. 2002 Aug; 14 Suppl 2:S42-7.IJ
The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve/maintain erections (P<0.01). Seventy-seven per cent of sildenafil- vs 46% of placebo-treated patients reported improved erections (P<0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P<0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P<0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.