| New
Studies Demonstrate Reliable Efficacy Using LevitraT (vardenafil
HCl)
09 July, 2003
New findings on the long-term benefits of LevitraT showed that
men with erectile dysfunction (ED) taking LevitraT reported clinically
significant, sustained improvement in erectile function (EF)
over a two-year period.1 LevitraT was also shown to be a reliable
and fast-acting agent for the treatment of ED in patients participating
in clinical trials.2,3 Results from the new studies were presented
earlier at the Second International Consultation on Erectile
and Sexual Dysfunctions, Paris, France, a meeting supported by
the World Health Organisation.
"It is impressive to find that LevitraT's excellent efficacy
is sustained for an extended period of time. If an ED drug loses
its effect over time, the full benefits of treatment are lost
and, as a result, men may lose confidence in their therapy and
their sexual function," said Dr Christopher Stief, a professor
in the department of urology at Medizinische Hochschule in Hannover
, Germany .
Study participants reported improved erectile function throughout
two years
A total of 755 men with ED completed a one-year treatment period
with LevitraT. Of those, 566 men agreed to continue to receive
Levitra 10 mg or 20 mg in a double-blind study for an additional
year. Of the 479 men who completed the study, two-year results
showed:1
- 9 in 10 men taking LevitraT reported improved erections throughout
the study period (92% of men taking LevitraT 20 mg and 90%
of men taking LevitraT 10 mg).4
- Not only did LevitraT significantly improve men's erectile
function, but study participants were reportedly five times
more likely, on average, to maintain their erections through
completion of sexual intercourse (89% vs. 17% at baseline for
men taking LevitraT 20 mg and 87% vs. 16% at baseline for men
taking LevitraT 10 mg).5
Additional studies show rapid onset of erections and high success
rates using LevitraT 20 mg
New data from other studies reinforced LevitraT's excellent
efficacy and reliability, specifically with respect to how quickly
and consistently it works in study participants.
- In one of these studies, significantly more men taking LevitraT 20
mg experienced an erection adequate for successful completion
of intercourse as early as 16 minutes after dosing than men
taking placebo in an at-home setting. Results from this multi-centre,
double-blind study were based on 498 patients randomised to
either LevitraT 20 mg or placebo.2
- In a second study, 76 percent of men reported successful
penetration on their first attempt at intercourse after taking
LevitraT 20 mg (versus 44% placebo) and the men who were successful
the first time also reported successful penetration 91 percent
of the time on subsequent attempts (versus 74% placebo). Findings
were based on a retrospective data analysis of two double-blind,
Phase III trials involving 1385 men for a 12-week study period.3
"Bayer and GSK are very pleased with these results as they
reinforce the body of evidence showing LevitraT not only improves
erectile function the first time and reliably time after time
but that this improvement is sustained over the long term," said
Dr Wolfgang Plischke, president, Bayer Pharmaceuticals division
of Bayer HealthCare. "Men want to be confident that the
ED drug they take works at the moment when they need it to and
we believe that Levitra provides such confidence."
In all studies, the most common adverse events were generally
mild to moderate and included headache, flushing and rhinitis
(nasal congestion).
References
- Stief C, Porst H, Saenz de Tejada I et al. Sustained efficacy
and tolerability of vardenafil over two years in men with erectile
dysfunction. To be presented at the 2nd International Consultation
on Erectile and Sexual Dysfunctions. Co-sponsored by the World
Health Organization (WHO), International Consultation on Urological
Diseases (ICUD) and Societé Internationale d'Urologie
(SIU), 28 June- 1 July 2003 , Paris .
- Padma-Nathan H, Kaufman, J, Taylor T. Earliest time of onset
of erections with vardenafil determined in an at-home setting.
To be presented at the 2nd International Consultation on Erectile
and Sexual Dysfunctions. Co-sponsored by WHO, ICUD and SIU,
28 June- 1 July 2003 , Paris.
- Montorsi F, Hellstrom W, Valiquette L et al. Reliable efficacy
over time of vardenafil, a potent, highly selective PDE-5 inhibitor
in men with erectile dysfunction: a retrospective analysis
of two pivotal phase lll studies. To be presented at the 2nd
International Consultation on Erectile and Sexual Dysfunctions.
Co-sponsored by WHO, ICUD and SIU, 28 June- 1 July 2003 , Paris.
- Based on the global assessment question (GAQ), a widely accepted
measure to evaluate ED treatment efficacy.
- Based on a diary question in the Sexual Encounter Profile
(SEP-3) related to completing sexual intercourse
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