Abstract
First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability -Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10mg or placebo for 12weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.
| Original language | English |
|---|---|
| Pages (from-to) | 1378-1385 |
| Number of pages | 8 |
| Journal | International Journal of Clinical Practice |
| Volume | 60 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 2006 |
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Keywords
- Comorbidities
- Erectile dysfunction
- Erection
- First-dose success
- PDE5 inhibitors
- Vardenafil
ASJC Scopus subject areas
- Medicine(all)
Cite this
First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities : RELY-I. / Valiquette, L.; Montorsi, F.; Auerbach, S.
In: International Journal of Clinical Practice, Vol. 60, No. 11, 11.2006, p. 1378-1385.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities
T2 - RELY-I
AU - Valiquette, L.
AU - Montorsi, F.
AU - Auerbach, S.
PY - 2006/11
Y1 - 2006/11
N2 - First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability -Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10mg or placebo for 12weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.
AB - First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability -Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10mg or placebo for 12weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.
KW - Comorbidities
KW - Erectile dysfunction
KW - Erection
KW - First-dose success
KW - PDE5 inhibitors
KW - Vardenafil
UR - http://www.scopus.com/inward/record.url?scp=33749859517&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33749859517&partnerID=8YFLogxK
U2 - 10.1111/j.1742-1241.2006.01170.x
DO - 10.1111/j.1742-1241.2006.01170.x
M3 - Article
C2 - 17073835
AN - SCOPUS:33749859517
VL - 60
SP - 1378
EP - 1385
JO - International Journal of Clinical Practice
JF - International Journal of Clinical Practice
SN - 1368-5031
IS - 11
ER -