Assessment of the efficacy and safety of Viagra (R) (sildenafil citrate) in men with erectile dysfunction during long-term treatment

Long-term efficacy and safety of sildenafil was assessed in 1008 patients w ith erectile dysfunction (ED) enrolled in four flexible-dose (25 - 100 mg), open-label, 36- or 52-week extension studies. After 36 and 52 weeks, 92% a nd 89% of patients felt that treatment with sildenafil had improved their e rections. Responses to a Sexual Function Questionnaire indicated that 52 we eks of sildenafil treatment resulted in clinically significant improvements in the duration and firmness of erections, overall satisfaction with sex l ife, and the frequency of stimulated erections. Commonly reported adverse e vents (AEs) were headache, flushing, dyspepsia, and rhinitis, which were ge nerally mild to moderate. Reports of abnormal vision were consistent with p revious clinical trials. The occurrence of treatment-related cardiovascular A-Es, such as hypertension, tachycardia, and palpitation, was < 1%. Discon tirmations due to treatment-related AEs were low (2%). Long-term therapy do es not diminish the efficacy of sildenafil in patients with ED and remains well tolerated.