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

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Authors: James G McMurray, Robert A Feldman, Stephen M Auerbach, Herb DeRiesthal, Neal Wilson et al

Published Date January 2007 Volume 2007:3(6) Pages 975 - 981
DOI: http://dx.doi.org/10.2147/TCRM.S

James G McMurray1, Robert A Feldman2, Stephen M Auerbach3, Herb DeRiesthal4 Neal Wilson5, On behalf of the Multicenter Study Group6

1Medical Affiliated Research Center, Huntsville, AL, USA; 2Connecticut Clinical Research Center, Waterbury, CT, USA; 3California Professional Research, Newport Beach, CA, USA; 4Pfizer Inc, New York, NY, USA; 5Formerly Pfizer Global Research and Development, Sandwich, UK, currently PPD Inc, Cambridge, UK; 6Members of the multicenter study group are listed in the appendix.

Abstract: 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.

Keywords: sildenafil citrate, erectile dysfunction, tolerability, effectiveness