Wise Young
04-16-2002, 07:55 PM
[P06.087] Efficacy of Sildenafil Citrate in Men with Erectile Dysfunction and Multiple Sclerosis: Results of an Open-Label Study
James R. Miller, Clare J. FowlerÂ*New York, NY; London, United Kingdom
OBJECTIVE: Sildenafil citrate (VIAGRA®) has previously been shown to improve erectile function in men with multiple sclerosis (MS) and erectile dysfunction (ED) in a placebo-controlled trial; this current study evaluates Viagra efficacy during an open-label extension (OLE).
BACKGROUND: The incidence of sexual dysfunction and specifically ED in men with MS is high, with reports ranging from 50% to 75%.
DESIGN/METHODS: This was an OLE of a 12-week, double-blind (DB), placebo-controlled trial evaluating the efficacy and safety of Viagra for the treatment of ED in men with MS. Men were eligible if they completed the DB phase or if they discontinued due to lack of efficacy. Overall, 206 patients (placebo, 106; Viagra, 100) entered and 180 patients completed the OLE phase. Because the initial blind was not broken until completion of both phases of the study, all patients started the OLE with 50-mg Viagra. After 24 to 48 weeks (the OLE phase continued until Viagra became commercially available in the study country, but no longer than 48 weeks), efficacy was evaluated with a 3-item Global Efficacy Assessment; Q1: Has the medication you have been taking improved your erections? Q2: If yes, has the improvement in your erections allowed you to engage in successful sexual activity? Q3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection satisfactory for sexual intercourse? Q3 was rated on a scale from 1 to 5, ranging from almost never/never to almost always/always.
RESULTS: Overall, 95% of patients had improved erections (Q1); of those patients, 95% also reported improved sexual activity (Q2). Patients who had received placebo in the DB phase showed a nearly 4-fold increase (97% vs. 26%) in improved erections (Q1) at the end of the OLE. An improvement in successful sexual activity (Q2) at the end of the OLE was reported by patients from both the DB placebo (96% vs. 73%) and DB Viagra groups (94% vs. 89%). However, since only patients who responded "yes" to Q1 were included here, these percentages are based on fewer patients from the DB placebo group (n=26) than from the DB Viagra group (n=81) answering Q2. For patients who received DB placebo, the frequency of erections more than doubled (mean score 4.35 vs. 1.98) and was similar to the frequency observed in patients who received DB Viagra (mean score 4.26) at the end of the OLE.
CONCLUSIONS: The efficacy of Viagra in patients with ED and MS was sustained over periods ranging from 24 to 48 weeks.
Supported By: Pfizer Inc
Category - MS and Related Diseases
SubCategory - Clinical Trials
James R. Miller, Clare J. FowlerÂ*New York, NY; London, United Kingdom
OBJECTIVE: Sildenafil citrate (VIAGRA®) has previously been shown to improve erectile function in men with multiple sclerosis (MS) and erectile dysfunction (ED) in a placebo-controlled trial; this current study evaluates Viagra efficacy during an open-label extension (OLE).
BACKGROUND: The incidence of sexual dysfunction and specifically ED in men with MS is high, with reports ranging from 50% to 75%.
DESIGN/METHODS: This was an OLE of a 12-week, double-blind (DB), placebo-controlled trial evaluating the efficacy and safety of Viagra for the treatment of ED in men with MS. Men were eligible if they completed the DB phase or if they discontinued due to lack of efficacy. Overall, 206 patients (placebo, 106; Viagra, 100) entered and 180 patients completed the OLE phase. Because the initial blind was not broken until completion of both phases of the study, all patients started the OLE with 50-mg Viagra. After 24 to 48 weeks (the OLE phase continued until Viagra became commercially available in the study country, but no longer than 48 weeks), efficacy was evaluated with a 3-item Global Efficacy Assessment; Q1: Has the medication you have been taking improved your erections? Q2: If yes, has the improvement in your erections allowed you to engage in successful sexual activity? Q3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection satisfactory for sexual intercourse? Q3 was rated on a scale from 1 to 5, ranging from almost never/never to almost always/always.
RESULTS: Overall, 95% of patients had improved erections (Q1); of those patients, 95% also reported improved sexual activity (Q2). Patients who had received placebo in the DB phase showed a nearly 4-fold increase (97% vs. 26%) in improved erections (Q1) at the end of the OLE. An improvement in successful sexual activity (Q2) at the end of the OLE was reported by patients from both the DB placebo (96% vs. 73%) and DB Viagra groups (94% vs. 89%). However, since only patients who responded "yes" to Q1 were included here, these percentages are based on fewer patients from the DB placebo group (n=26) than from the DB Viagra group (n=81) answering Q2. For patients who received DB placebo, the frequency of erections more than doubled (mean score 4.35 vs. 1.98) and was similar to the frequency observed in patients who received DB Viagra (mean score 4.26) at the end of the OLE.
CONCLUSIONS: The efficacy of Viagra in patients with ED and MS was sustained over periods ranging from 24 to 48 weeks.
Supported By: Pfizer Inc
Category - MS and Related Diseases
SubCategory - Clinical Trials