TY  - EJOU
AU  - Valiquette, Luc 
AU  - Montorsi, Francesco 
AU  - Hellstrom, Wayne J. G. 
AU  - Giuliano, Francois 
AU  - Homering, Martin 
AU  - Taylor, Terry 
AU  - Eardley, Ian 

TI  - Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis
T2  - Canadian Journal of Urology

PY  - 2005
VL  - 12
IS  - 3
SN  - 1488-5581

AB  - <b>Objective:</b> To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials.<br/>
<b>Methods:</b> In two randomized, double-blind studies, men with ED for >6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment.<br/>
<b>Results:</b> Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from ≤15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from ≤15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%).<br/>
<b>Conclusion:</b> In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).
KW  - vardenafil
KW  -  erectile dysfunction
KW  -  onset
KW  -  reliability

DO  -