Room 519-A | Sexual Dysfunction (ED) Monday, July 11, 2005 Time: 8:30 AM-10:30 AM |
Viagra long-term efficacy and quality of life: Results of Canadian long-term study.
Carrier, Serge*,1, Morales, Alvaro2, Defoy, Isabelle3, 1 McGill University, Montreal, Quebec, Canada2 Kingston General Hospital, Kingston, Ontario, Canada3 Pfizer Canada Inc, Kirkland, Quebec, Canada
ABSTRACT- The efficacy of sildenafil citrate (VIAGRA®) has been clearly established during clinical trials of 3- to 6-month duration. The primary objective of this study was to assess the maintenance of long-term efficacy (3 years) and satisfaction with continued use of sildenafil taken as required prior to sexual activity by patients with erectile dysfunction (ED). This multi-center, non-comparative study was an open-label extension of a double-blind randomized placebo-controlled trial. Patients were eligible if they had been initially randomized to sildenafil and had successfully completed the double-blind trial. Efficacy was measured through the IIEF and the GAQ (Are you satisfied with the effect that the treatment you have been receiving is having on your erections?). For all patients, results were available at month 0 (start of double-blind), month 3 (end of double-blind) and month 36 (end of open-label extension). The intent-to-treat population included 225 patients. Scores for the erectile function, orgasmic function, intercourse satisfaction and overall satisfaction domains of the IIEF showed no difference between months 3 and 36, although there was a statistical improvement between month 0 and month 3 of treatment. Quality of life, as assessed with the SF-12 questionnaire, showed no deterioration between months 3 and 36. Interestingly, the impact of their erectile problems, as assessed through the Erectile Distress Scale, was improved with time, with a score of 23.6 at month 3 and 24.7 at month 36 (p<0.02). After 36 months of treatment, 75% of men felt that their erection problems were none/a little of the time a worry in their life, as opposed to 64% at month 3. Overall, the results presented here demonstrate that sildenafil is as effective after 36 months of treatment as it was during the double-blind controlled study. Quality of life is still maintained after 3 years of treatment and erection problems are less bothersome after 3 years of treatment. There was no evidence of tachyphylaxis in this study. After 3 years of treatment, a vast majority of patients are still satisfied with the effect of sildenafil on their erections. This study also supports the long-term safety of sildenafil in patients with ED.
Key words: erectile dysfunction, Long-term efficacy, Quality of life, Viagra