Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study.
Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America; and (2) to correlate Rigiscan measurements assessing ED etiology with the investigator's assessment. A total of 141 men with broad-spectrum ED (mean age 57) were enrolled in a randomized, 12-week, double-blind, placebo-controlled, flexible-dose escalation study of sildenafil. After the 12-week treatment period, the mean score for the primary efficacy variables had risen significantly: for the sildenafil group, 66.2% from baseline for question 3 of the International Index of Erectile Function and 77.6% for question 4, vs 15.1% and 21.2% for the placebo group, respectively (P<0.0001). Rigiscan data confirmed investigator assessments of etiology. Headache and flushing, usually mild and transient, were the most common adverse events. Sildenafil was an effective, well-tolerated treatment for men in southern Latin America with broad-spectrum ED.
Becher
E
E
Centro de Diagnóstico Urológico, Buenos Aires, Argentina. ebecher@edu.com.ar
Tejada Noriega
A
A
Gomez
R
R
Decia
R
R
D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010919:Placebos; D011687:Purines; D012449:Safety; D000068677:Sildenafil Citrate; D013450:Sulfones; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D010879:Piperazines; D010919:Placebos; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate