Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction (ED), many men may choose to use it for an extended period. Men with ED who had previously completed 1 of 4 double-blind trials with short-term open-label extension (combined duration, 0.9–1.2 years) were eligible for this 4-year, open-label, extension study, which assessed the safety and effectiveness of flexible doses (25, 50, and 100 mg sildenafil) used as needed. Adverse events that were serious or led to dosing changes or discontinuation (temporary or permanent) were recorded. Many of the 979 participants (mean age, 58 [range, 27–82] years; mean ED duration, 4.5 years) had concomitant hypertension (28%), diabetes (22%), or hyperlipidemia (14%). Overall, 37 (3.8%) had treatment-related adverse events (none serious) requiring dosage change or discontinuation and 62 (6.3%) discontinued because of insufficient response. 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 sildenafil treatment of men with ED.
In March 1998, the US Food and Drug Administration (FDA) approved sildenafil citrate (Viagra®, Pfizer Inc, New York, NY, USA) for the treatment of erectile dysfunction (ED) (FDA 1998). As of December 2005, more than 27 million men worldwide had received sildenafil for treatment of ED, including an estimated 17 million men in the US (Data on file, Pfizer Inc, New York, NY). Thus, the long-term safety and effectiveness of sildenafil can now be evaluated in men who have been taking the drug for several years.
The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less. For example, 1,358 men with ED completed 1 of 4 double-blind trials and continued with open-label sildenafil treatment in extension studies for a total treatment duration of approximately 1 year (Morales et al 1998; Steers et al 2001). In the current study, 979 of these men subsequently received up to 4 more years of open-label, flexible-dose (25, 50, and 100 mg) sildenafil. Preliminary (3-year) results were reported previously (Carson et al 2002; Padma-Nathan et al 2002), and we now present the final data. The population included patients with ED of organic and psychogenic etiology and typical concomitant medical conditions for this population (ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease). Our objective was to assess the long-term safety and effectiveness of sildenafil treatment in men with ED.
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