- Email: [email protected]
MP48-11 TIME TO ERECTOGENIC EFFECT OF AVANAFIL IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL
THE JOURNAL OF UROLOGYâ
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
RESULTS: 423 pts were randomized to OaD (N¼139), PRN (N¼143), and PLC (N¼141); 114/122/155 completed 9mo DBT. Greater retained SPL was observed with OaD vs PLC at eDBT (Figure; LS mean [95%CI] difference OaD vs PLC, 4.1 [0.4, 7.8] mm, p¼0.032). No significant LS mean difference (p >0.05) was observed for PRN vs PLC. No significant effect of NSS on SPL loss was observed (Figure). Penile tumescense (SEP 1) as the initial sign of EF recovery was improved significantly vs. PLC at eDBT and OLT for pts randomized to OaD only. The ability for sexual intercourse (SEP 3) also significantly improved for pts on OaD vs placebo only at eDBT. The distribution of SMEQ responses was different at eDBT (p¼0.045), with 34.2% of pts on OaD, 50.0% on PRN and 56.5% on PLC reporting the absence of morning erections, At eDFW, SEP responses were not statistically significantly different between OaD and PLC. CONCLUSIONS: These data suggest that the early initiation of treatment with TAD OaD protects from penile length-loss and may contribute to protection from structural cavernosal changes post nsRP.
e531
significant improvements were observed in all endpoints, including successful intercourse attempts (SEP3) within approximately 15 minutes after dosing with both avanafil doses (P<.01 vs placebo; Table) and as early as 10 minutes post-dosing in the avanafil 200-mg group and 12 minutes post-dosing in the avanafil 100-mg group (P<.01 vs placebo). Common adverse events were headache, nasopharyngitis, and flushing. CONCLUSIONS: Avanafil had a significant erectogenic effect compared with placebo, including successful achievement of SEP2, SEP3, and changes in the IIEF-EF domain score. Furthermore, a significant number of sexual attempts were successful within approximately 15 minutes post-dosing. Table. Erectogenic Effects of Avanafil in Men With Mild to Severe ED During 8 Weeks of Treatment (ITT). Placebo
Avanfil 100 mg
Avanafil 200 mg
Successful Vaginal Penetration, SEP2 n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
43.5 (3.2)
65.0 (3.2)*
65.4 (3.2)*
Successful Intercourse, SEP3 n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
27.7 (3.3)
47.0 (3.3)*
48.7 (3.3)*
Successful Intercourse (SEP3) Within Approximately 15 Minutes Post-dosingz n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
13.8 (2.9)
24.7 (2.9)y
28.2 (2.9)*
IIEF-EF Domain Score n LS Mean (SE)
Source of Funding: The study was funded by Eli Lilly and Company.
135
138
139
13.9 (0.8)
18.1 (0.8)*
19.1 (0.8)*
* P< .001 vs placebo; yP=.002 vs placebo; zAny erectogenic effect that had a stopwatch time of 17 minutes to include up to 17 minutes and 59 seconds could be considered to be within approximately 15 minutes. ITT, intent-to-treat population; LS, least squares; SE, standard error
Source of Funding: VIVUS, Inc.
MP48-11 TIME TO ERECTOGENIC EFFECT OF AVANAFIL IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL
MP48-12
Wayne J. G. Hellstrom*, New Orleans, LA; David Cook, Winston-Salem, NC; LeRoy Jones, San Antonio, TX; Charles H. Bowden, Wesley W. Day, Chien-Feng Chen, Mountain View, CA
EVALUATION OF NOCTURNAL TUMESCENCE AND ITS RESPONSE TO NIGHTLY SILDENAFIL CITRATE FOLLOWING RADICAL PROSTATECTOMY: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY
INTRODUCTION AND OBJECTIVES: Avanafil is a highly specific phosphodiesterase type 5 inhibitor approved for the treatment of erectile dysfunction (ED). This phase 4 study examined the efficacy and safety of avanafil approximately 15 minutes after dosing in men with mild to severe ED. METHODS: In this double-blind, 12-week (4-week run-in; 8-week treatment period) study, patients were randomized to placebo (n¼145), avanafil 100 mg (n¼147), or avanafil 200 mg (n¼148). Sexual function was assessed at baseline and at all follow-up visits using patient diaries and the International Index of Erectile Function (IIEF). The primary objective was to assess positive responses to Sexual Encounter Profile question 3 (SEP3) within approximately 15 minutes post-dosing. Patients were encouraged to attempt intercourse approximately 15 minutes post-dosing; stopwatches were used to measure timing of response. Other endpoints included the percentage of sexual attempts in which patients were able to insert the penis into the partner’s vagina (SEP2), percentage of successful sexual attempts in which patients maintained an erection of sufficient duration to have successful intercourse (SEP3), and change in the erectile function (EF) domain of IIEF. RESULTS: At baseline, mean age was 5810 years; 41% of patients had severe ED; mean duration of ED was 8970 months, and 60% had a history of sildenafil use. After 8 weeks of treatment,
Daniel Kim*, Dorota Hawksworth, Bethesda, MD; Judith Travis, Jennifer Cullen, Lauren Hurwitz, Rockville, MD; Stephen Brassell, Boise, ID; Inger Rosner, Bethesda, MD; Tom Lue, San Francisco, CA; Robert Dean, Bethesda, MD INTRODUCTION AND OBJECTIVES: Sildenafil citrate has been found efficacious therapy for post-prostatectomy impotence. In this study, we evaluated patterns of erectile function recovery following radical prostatectomy, and response to nightly therapy with Sildenafil citrate. METHODS: Ninety-four patients who underwent nerve sparing radical prostatectomy for localized prostate cancer were randomized to receive either a nightly 50mg dose of Sildenafil or placebo, starting on the first post-operative day and continuing for one year. Their erectile function was evaluated prior to surgery and at 2 weeks, 3, 6, 9, 12 and 13 months post-operatively. Both subjective, self-reported International Index of Erectile Function Questionnaire (IIEF) scores and objective, nocturnal penile tumescence and rigidity (NPT/ RigiScanÔ) measures were obtained and analyzed. RESULTS: Baseline clinical and demographic characteristics were not statistically different between the treatment groups. Seventy of the 94 patients (74.5%) completed the study. A total of 518 NPTR evaluations were performed using RigiScanÔ recorder. Pre-operatively,
Vol. 191, No. 4S, Supplement, Monday, May 19, 2014
RESULTS: 423 pts were randomized to OaD (N¼139), PRN (N¼143), and PLC (N¼141); 114/122/155 completed 9mo DBT. Greater retained SPL was observed with OaD vs PLC at eDBT (Figure; LS mean [95%CI] difference OaD vs PLC, 4.1 [0.4, 7.8] mm, p¼0.032). No significant LS mean difference (p >0.05) was observed for PRN vs PLC. No significant effect of NSS on SPL loss was observed (Figure). Penile tumescense (SEP 1) as the initial sign of EF recovery was improved significantly vs. PLC at eDBT and OLT for pts randomized to OaD only. The ability for sexual intercourse (SEP 3) also significantly improved for pts on OaD vs placebo only at eDBT. The distribution of SMEQ responses was different at eDBT (p¼0.045), with 34.2% of pts on OaD, 50.0% on PRN and 56.5% on PLC reporting the absence of morning erections, At eDFW, SEP responses were not statistically significantly different between OaD and PLC. CONCLUSIONS: These data suggest that the early initiation of treatment with TAD OaD protects from penile length-loss and may contribute to protection from structural cavernosal changes post nsRP.
e531
significant improvements were observed in all endpoints, including successful intercourse attempts (SEP3) within approximately 15 minutes after dosing with both avanafil doses (P<.01 vs placebo; Table) and as early as 10 minutes post-dosing in the avanafil 200-mg group and 12 minutes post-dosing in the avanafil 100-mg group (P<.01 vs placebo). Common adverse events were headache, nasopharyngitis, and flushing. CONCLUSIONS: Avanafil had a significant erectogenic effect compared with placebo, including successful achievement of SEP2, SEP3, and changes in the IIEF-EF domain score. Furthermore, a significant number of sexual attempts were successful within approximately 15 minutes post-dosing. Table. Erectogenic Effects of Avanafil in Men With Mild to Severe ED During 8 Weeks of Treatment (ITT). Placebo
Avanfil 100 mg
Avanafil 200 mg
Successful Vaginal Penetration, SEP2 n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
43.5 (3.2)
65.0 (3.2)*
65.4 (3.2)*
Successful Intercourse, SEP3 n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
27.7 (3.3)
47.0 (3.3)*
48.7 (3.3)*
Successful Intercourse (SEP3) Within Approximately 15 Minutes Post-dosingz n LS Mean Percentage of Sexual Attempts (SE)
136
138
139
13.8 (2.9)
24.7 (2.9)y
28.2 (2.9)*
IIEF-EF Domain Score n LS Mean (SE)
Source of Funding: The study was funded by Eli Lilly and Company.
135
138
139
13.9 (0.8)
18.1 (0.8)*
19.1 (0.8)*
* P< .001 vs placebo; yP=.002 vs placebo; zAny erectogenic effect that had a stopwatch time of 17 minutes to include up to 17 minutes and 59 seconds could be considered to be within approximately 15 minutes. ITT, intent-to-treat population; LS, least squares; SE, standard error
Source of Funding: VIVUS, Inc.
MP48-11 TIME TO ERECTOGENIC EFFECT OF AVANAFIL IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL
MP48-12
Wayne J. G. Hellstrom*, New Orleans, LA; David Cook, Winston-Salem, NC; LeRoy Jones, San Antonio, TX; Charles H. Bowden, Wesley W. Day, Chien-Feng Chen, Mountain View, CA
EVALUATION OF NOCTURNAL TUMESCENCE AND ITS RESPONSE TO NIGHTLY SILDENAFIL CITRATE FOLLOWING RADICAL PROSTATECTOMY: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY
INTRODUCTION AND OBJECTIVES: Avanafil is a highly specific phosphodiesterase type 5 inhibitor approved for the treatment of erectile dysfunction (ED). This phase 4 study examined the efficacy and safety of avanafil approximately 15 minutes after dosing in men with mild to severe ED. METHODS: In this double-blind, 12-week (4-week run-in; 8-week treatment period) study, patients were randomized to placebo (n¼145), avanafil 100 mg (n¼147), or avanafil 200 mg (n¼148). Sexual function was assessed at baseline and at all follow-up visits using patient diaries and the International Index of Erectile Function (IIEF). The primary objective was to assess positive responses to Sexual Encounter Profile question 3 (SEP3) within approximately 15 minutes post-dosing. Patients were encouraged to attempt intercourse approximately 15 minutes post-dosing; stopwatches were used to measure timing of response. Other endpoints included the percentage of sexual attempts in which patients were able to insert the penis into the partner’s vagina (SEP2), percentage of successful sexual attempts in which patients maintained an erection of sufficient duration to have successful intercourse (SEP3), and change in the erectile function (EF) domain of IIEF. RESULTS: At baseline, mean age was 5810 years; 41% of patients had severe ED; mean duration of ED was 8970 months, and 60% had a history of sildenafil use. After 8 weeks of treatment,
Daniel Kim*, Dorota Hawksworth, Bethesda, MD; Judith Travis, Jennifer Cullen, Lauren Hurwitz, Rockville, MD; Stephen Brassell, Boise, ID; Inger Rosner, Bethesda, MD; Tom Lue, San Francisco, CA; Robert Dean, Bethesda, MD INTRODUCTION AND OBJECTIVES: Sildenafil citrate has been found efficacious therapy for post-prostatectomy impotence. In this study, we evaluated patterns of erectile function recovery following radical prostatectomy, and response to nightly therapy with Sildenafil citrate. METHODS: Ninety-four patients who underwent nerve sparing radical prostatectomy for localized prostate cancer were randomized to receive either a nightly 50mg dose of Sildenafil or placebo, starting on the first post-operative day and continuing for one year. Their erectile function was evaluated prior to surgery and at 2 weeks, 3, 6, 9, 12 and 13 months post-operatively. Both subjective, self-reported International Index of Erectile Function Questionnaire (IIEF) scores and objective, nocturnal penile tumescence and rigidity (NPT/ RigiScanÔ) measures were obtained and analyzed. RESULTS: Baseline clinical and demographic characteristics were not statistically different between the treatment groups. Seventy of the 94 patients (74.5%) completed the study. A total of 518 NPTR evaluations were performed using RigiScanÔ recorder. Pre-operatively,