An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra® (sildenafil citrate) in males with erectile dysfunction and arterial hypertension who are taking antihypertensive treatment

Abstract

Purpose: To evaluate the safety and efficacy of sildenafil citrate in men with erectile dysfunction, who had been taking antihypertensive agents, and to provide supportive scientific data, which can be used as a reference when prescribing sildenafil citrate. Materials and methods: 198 male subjects, aged 20 years or older, between September 2002 and June 2003, were enrolled. The subjects were comprised of those patients with arterial hypertension, taking one or more antihypertensive agents, and who had been diagnosed with erectile dysfunction of more than 3 months duration. This study was conducted for 10 weeks as an open-label, multi-center and flexible dose clinical study, with a 2-week screening period and 8-week treatment phase. At all visits, the heart pressure and heart rate were measured, with any concomitant medications and adverse events recorded for each subject. Subjects were asked to complete the Event Log Worksheets, questionnaires of the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Question (GEAQ) during the study period. Results: 167 subjects completed this study. The average age and duration of erectile dysfunction were 55.8 (31.7 to 77.1) years old and 3.3 years, respectively. The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline, to 3.7 and 3.4 at week 4 and to 3.8 and 3.4 at week 8, respectively. 86.3 and 88.3% of patients answered that they had an improved erectile function and ability to have sexual intercourse, respectively, by week 8. There were no significant differences in responses to questions 3 and 4 of the IIEF and GEAQ in relation to the number of antihypertensive agents taken. The adverse events experienced during the study were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), chest pain (2.2%) and nausea (1.7%). Only 4 patients discontinued treatment due to adverse events. Conclusions: According to the results of this study, sildenafil citrate was concluded to not only be effective at improving erections, but was also well tolerated and safe in the treatment of men with erectile dysfunction who were also taking multiple antihypertensive agents for arterial hypertension.