ABSTRACT
Objective: The aim of the study was to assess the safety/tolerability and the efficacy of sildenafil citrate (Viagra TM) in Filipino patients diagnosed with erectile dysfunction (ED) of different etiologies and severityMethodology: This is an open-label, multi-center study, with the primary objective of obtaining adverse reactions that may occur with the use of sildenafil citrate (Viagra TM) 25 mg, 50 mg or 100 mg once daily on as per needed basis, in the out-patient clinic setting across the Philippines. As a secondary endpoint, the study evaluates the efficacy of sildenafil citrate (Viagra TM) in the everyday clinical practice of Filipino physicians, using the Patient Global Efficacy Assessment Questions. Safety and toleration were assessed on the follow-up visit using unsolicited and non-leading questioning. All observed and reported events were recorded regardless of a suspected causal relationship to the study drugResults: Within a three year period, a total 3,955 study participants were enrolled in the study. Majority (57.4 percent) of the patients were suffering from organic or mixed type (a combination of both psychogenic and organic) of erectile dysfunction while 39.5 percent were of psychogenic origin. Among the adverse events reported by the patients, headache (4.5 percent), vasodilatation (2.4 percent) and dizziness (1.7 percent), showed the highest proportions. Majority (75.1 percent) reported that these were mild in nature. There were no reported serious adverse events nor were there reported deaths with the use of sildenafil citrate (Viagra TM) during the study. Majority (78.9 percent) reported improvement in their erection after taking the treatment. A fifth (19.8 percent) of the respondents failed to provide information on this item. However, almost all of the patients were either satisfied or very satisfied with the treatment representing 91.6 percent of the patientsConclusion: Sildenafil citrate (Viagra TM) is a safe and effective medication for the treatment of erectile dysfunction of various etiologies in the Filipino population. Almost all of the patients taking sildenafil citrate (Viagra) were satisfied with the treatment. The results of this study reinforce the proven safety and efficacy profile of sildenafil citrate (Viagra) among Filipino patients with erectile dysfunction. (Author)