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Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations.
- Source :
-
The journal of sexual medicine [J Sex Med] 2011 Oct; Vol. 8 (10), pp. 2912-23. Date of Electronic Publication: 2011 Aug 30. - Publication Year :
- 2011
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Abstract
- Introduction: Patients and physicians consider a rapid onset of action to be an important attribute of oral pharmacotherapy for erectile dysfunction.<br />Aim: To investigate the time to onset of action of a new orodispersible tablet (ODT) formulation of vardenafil.<br />Methods: A post hoc integrated analysis was performed on data from two 12-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled phase III trials of 10 mg vardenafil ODT. Data for the vardenafil film-coated tablet were generated from a retrospective integrated analysis at week 12 of four double-blind, multicenter, randomized, parallel-group, fixed-dose, placebo-controlled phase III trials. Time intervals (in 15-, 30-, and 60-minute increments, up to ≥6 hours after study medication intake) were determined for the period between dosing and start of sexual activity (with the intention of intercourse).<br />Main Outcome Measures: The total number of sexual intercourse attempts and Sexual Encounter Profile question 3 (SEP3) success rates were calculated per time interval.<br />Results: Within 15 minutes postdosing, mean per-patient SEP3 success rates were 62.5% (vardenafil ODT) vs. 29.4% (placebo), with corresponding overall SEP3 success rates of 59.8% and 38.2%. In this time interval, 5.3% vs. 2.8% of all sexual activity attempts were initiated by subjects taking vardenafil ODT (n = 89) or placebo (n = 62), respectively. At 16-30 minutes postdosing, SEP3 success rates were 65.3% and 32.6% (mean per-patient) and 70.2% and 51.0% (overall) for vardenafil ODT vs. placebo, respectively, with a corresponding 10.4% and 8.7% of all sexual activity attempts being made by subjects taking vardenafil ODT (n = 170) or placebo (n = 118). Comparable results were observed for vardenafil 10 and 20 mg film-coated tablet at corresponding time intervals.<br />Conclusions: Vardenafil ODT shows a rapid onset of action comparable with that of vardenafil film-coated tablet. In those men who begin sexual activity within 30 minutes after dosing, the majority of sexual attempts lead to successful intercourse.<br /> (© 2011 International Society for Sexual Medicine.)
- Subjects :
- Administration, Oral
Adult
Aged
Aged, 80 and over
Delayed-Action Preparations administration & dosage
Delayed-Action Preparations pharmacokinetics
Double-Blind Method
Humans
Imidazoles pharmacokinetics
Imidazoles therapeutic use
Male
Middle Aged
Phosphodiesterase 5 Inhibitors pharmacokinetics
Phosphodiesterase 5 Inhibitors therapeutic use
Piperazines pharmacokinetics
Piperazines therapeutic use
Retrospective Studies
Sexual Behavior drug effects
Sulfones administration & dosage
Sulfones pharmacokinetics
Sulfones therapeutic use
Tablets administration & dosage
Tablets pharmacokinetics
Time Factors
Treatment Outcome
Triazines administration & dosage
Triazines pharmacokinetics
Triazines therapeutic use
Vardenafil Dihydrochloride
Young Adult
Erectile Dysfunction drug therapy
Imidazoles administration & dosage
Phosphodiesterase 5 Inhibitors administration & dosage
Piperazines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1743-6109
- Volume :
- 8
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- The journal of sexual medicine
- Publication Type :
- Academic Journal
- Accession number :
- 21883954
- Full Text :
- https://doi.org/10.1111/j.1743-6109.2011.02462.x