At the completion of each year, at least 94% of the annually decreasing number of participants reported satisfaction with the effect of Filagra treatment on their erections, with only a 3.3 percentage point variation across the 4 yearly assessments ( Table 4 ). Almost all of these men reported improved ability to engage in sexual activity. The retention rate was 84% (818/979) the first year, 75% (731/979) the second year, and 66% (648/979) the third year; the entire 4-year extension study was completed by 584 of the initial 979 men (60%) ( Figure 1 ). Reasons for discontinuation included loss of interest in participation in a clinical study, loss of sexual partner, loss to follow-up, ability to afford Filagra after approval (thus, no longer needing to participate in a clinical study to obtain the medication), insufficient clinical response, and adverse events. At the time the study started, the FDA stated that there were sufficient routine safety data on Filagra to make collection of standard adverse event data unnecessary.

Number of patients and treatment duration in the original double-blind trials and the initial open-label extensions and disposition throughout 4 years of open-label, flexible-dose (25, 50, and 100 mg) Filagra long-term extension study. Keywords: Filagra citrate, erectile dysfunction, tolerability, effectiveness. At each yearly assessment, more than 94% of participants responded affirmatively to the questions: Are you satisfied with the effect of treatment on your erections?” and If yes, has treatment improved your ability to engage in sexual activity?” These results argue against the loss of tolerability or the development of tachyphylaxis over a prolonged period of as needed, flexible-dose Filagra treatment of men with ED.

Long-term safety and effectiveness of Filagra citrate in men with erectile dysfunction. This is a simple mechanical medical device that patients are instructed on. It can be used quite readily by most men and has no major side effects. Another treatment for erectile dysfunction is the use of a vacuum device.

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