Title: EFFICACY AND SAFETY OF SILDENAFIL CITRATE FOR THE TREATMENT OF ERECTILE DYSFUNCTION IN LATIN AMERICA
Abstract: In this 12-week, double blind, randomized, placebo-controlled, multicenter, parallel group, flexibledose study of oral sildenafil, 245 patients were treated in 15 centers in Latin America (9 in Brazil and 6 in Mexico). Patients began treatment with a 50-mg dose of sildenafil or matching placebo that could be adjusted to 100 mg or 25 mg based on efficacy and tolerability. One hundred twenty-four patients were randomized to receive sildenafil and 121 to receive placebo. The most common concomitant medical condition was unspecified essential hypertension in 24% and 29% of the patients in the placebo and sildenafil groups, respectively. Scores for the 2 primary efficacy variables, frequency of penetration and frequency of maintained erection (International Index of Erectile Function Question 3 and Question 4), were both significantly greater in the sildenafil group (p < 0.001) compared with the placebo group. The number of patients who felt the study drug had improved their erections (36% for placebo vs. 81% for sildenafil) and the mean proportion of successful attempts at sexual intercourse during the last 4 weeks (32% for placebo vs. 71% for sildenafil) was also significantly higher for patients receiving sildenafil (p < 0.001). Sildenafil was well tolerated with only 1 discontinuation due to a treatment-related adverse event (headache). Mild headache and flushing were the most frequently reported adverse events. None of the 6 serious adverse events (5 in the placebo group vs. 1 in the sildenafil group) was considered to be related to treatment. In conclusion, sildenafil is a well tolerated and effective treatment for erectile dysfunction of psychogenic, organic, or mixed etiology in Latin American men.
Publication Year: 2001
Publication Date: 2001-01-01
Language: en
Type: article
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Cited By Count: 12
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