The efficacy, safety and tolerability of sildenafil in the treatment of men with erectile dysfunction have been demonstrated in numerous studies of 1 year duration or less. For example, 1,358 men with erectile dysfunction completed 1 of 4 double-blind trials and continued open-label sildenafil treatment in extension studies for a total treatment duration of approximately 1 year. In the current study, 979 of these men subsequently received up to 4 more years of open-label, flexible-dose Cost of Sildenafil citrate (25, 50, and 100 mg). Preliminary results (3 years) were previously reported (Carson et al 2002; Padma-Nathan et al 2002), and we now present the final data. The population included patients with erectile dysfunction of organic and psychogenic etiology and concomitant medical conditions typical of this population (ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease). Our objective was to evaluate the long-term safety and efficacy of sildenafil treatment in men with erectile dysfunction. |