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Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction.

1 Medical Affiliated Research Center, Huntsville, AL, USA. 2 Connecticut Clinical Research generic no prescription viagra Center, Waterbury, CT, USA. 3 California Professional Research, Newport Beach, CA, USA. 5 Formerly Pfizer Global Research and Development, Sandwich, UK, currently PPD Inc, Cambridge, UK.

6 Members of the multicenter study group are listed in

the

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

development

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 generic no prescription viagra 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, generic no prescription viagra and 100 mg) sildenafil.

Preliminary (3-year) results were reported previously (Carson et al 2002; Padma-Nathan et al

2002

Our objective was to assess the long-term safety and effectiveness of sildenafil treatment in men with ED. This was a 4-year, open-label, flexible-dose (25, 50, and 100 mg) study of sildenafil.

Men who previously completed and were compliant with sildenafil or placebo treatment in 1 of 4 double-blind, placebo-controlled trials, and subsequently completed and were compliant with sildenafil treatment in initial open-label extension, were eligible for inclusion in this long-term extension study. Compliance was assessed by medication diaries and by continued study participation. A total of 1,545 men were originally enrolled in the double-blind trials, with 1,358 of these men continuing in the initial open-label extension studies.

The current study includes 979 of the original patients, who agreed to participate in the long-term extension ( Figure 1 ). The procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional). 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) sildenafil long-term extension study. Of the 979 participants who entered the sildenafil long-term extension study, 584 (60%) completed all 4 years.

Reasons for discontinuation, other than insufficient clinical response and treatment-related adverse event (AE), included AE unrelated to treatment, protocol violation, loss to follow-up, and other (eg, loss of interest in participation in a clinical study, loss of sexual partner, and ability to afford sildenafil after approval [thus, no longer needing to participate in a clinical study to obtain the medication]).