Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction (ED), many men may choose to use it for a long period of time. Men with ED who had previously completed 1 of 4 double-blind short-term open-label extension trials (combined duration, 0.9–1.2 years) were eligible for this 4-year open-label extension study, which evaluated the safety and efficacy of flexible doses (25, 50, and 100 mg sildenafil) used as needed. Adverse events that were serious or that led to dose changes or discontinuation (temporary or permanent) were recorded. Many of the 979 participants (mean age, 58 [range, 27–82] years; mean duration of ED, 4.5 years) had concomitant hypertension (28%), diabetes (22%), or hyperlipidemia (14%). Overall, 37 (3.8%) had treatment-related adverse events (none serious) that required dose changes or discontinuation, and 62 (6.3%) discontinued due to insufficient response. In each annual evaluation, more than 94% of the participants answered affirmatively to the questions: "Are you satisfied with the effect of the treatment on your erections?" and "If yes, has the treatment improved your ability to engage in sexual activity?" These results argue against loss of tolerability or the development of tachyphylaxis during a prolonged period of treatment with flexible doses of Cost of Viagra as needed for men with erectile dysfunction.

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