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Treatment with Levitra can result in an erection in just 10
minutes in some men and in most men within 25 minutes. A new
clinical study that measured the speed with which men with ED
can achieve an erection demonstrated that Levitra has the most
rapid onset to date of any PDE-5 inhibitor on the market. The
study will be presented at the 7th European Federation of Sexology
(EFS) congress in Brighton this week.
The study (called ONTIME - ONseT of Vardenafil In Men with
Erectile Dysfunction), presented in the UK, showed that Levitra
had a statistically significant response superior to placebo
at 10 and 11 minutes with 10 mg and 20 mg doses, respectively.
The ONTIME study assessed the earliest time elapsed from dosing
to attainment of an erection adequate for penetration leading
to completion of successful intercourse (as measured by SEP3
).
"The results of the ONTIME study show Levitra demonstrated
the fastest onset of action to date, meaning men can be confident
and engage in a satisfying sexual experience when they want
to," says Professor Francesco Montorsi, study investigator
and Associate Professor of Urology at the Universita' Vita
Salute San Raffaele in Milan.
In another study presented at the congress, speed of action
was an essential attribute of ED treatment, more so than duration,
according to the largest published survey of male sexuality
(Men's Attitudes to Life Events and Sexuality [MALES]). This
study found that in men with ED, rapid onset was considered
important irrespective of age, while long duration of action
became less important as men aged.
"The combined results of these studies demonstrate that
men value a rapid onset of action and that Levitra offers
patients what they want," concluded Professor Montorsi.
The MALES study included interviews with 2912 men, aged 20-75,
from 8 countries (UK, US, Germany, France, Italy, Spain, Mexico
and Brazil).
The ONTIME study was conducted in 724 patients in 80 centres
in Europe and North America (8 countries). It was a randomised,
double blind, parallel group, multicentre trial, which studied
men with ED (baseline IIEF-EF score of 13.0 [moderate severity],
ITT population ). The study design included a four-week unmedicated
run-in period, followed by a four-week treatment with Levitra
10 mg, 20 mg or placebo, taken on demand. The first four doses
were used to determine the earliest time of onset.
In the ONTIME study, the most common drug-related adverse
events were generally mild to moderate and included headache,
flushing, rhinitis and dyspepsia.
Erectile dysfunction (ED) is defined as the consistent or
recurrent inability of a man to attain and/or maintain a penile
erection sufficient for sexual performance. 2
It is estimated that some degree of ED affects more than
one half of all men over the age of 40 and that worldwide
an estimated 152 million men suffer from ED. The number of
men with ED is expected to more than double to 322 million
by 2025. 3,4 , Despite the high prevalence of sexual dysfunction,
experts estimate that only 15-20 percent of men with ED are
currently treated. 5
Phosphodiesterase type 5 (PDE-5) is the predominant enzyme
found in human penile erectile tissue and is associated with
erections. PDE-5 inhibitors typically work by blocking this
enzyme to enhance or prolong the erectile response.
Levitra was specifically selected for development as an ED
therapy because of its in vitro potency and high selectivity
for the inhibition of the PDE-5 enzyme.
Levitra 5, 10 and 20 mg doses are contraindicated in men
taking nitrates and nitric oxide donors (a group of medications
used to treat angina pectoris, or chest pain), in men concomitantly
using HIV protease inhibitors (such as indinavir and ritonavir),
and in patients with a known hypersensitivity to any component
of the tablet. Please refer to individual country labels for
other important prescriber information.
Levitra, researched and discovered by Bayer AG, is marketed
by Bayer and GlaxoSmithKline plc (GSK) through a worldwide
co-promotion and co-development agreement. Levitra was approved
on 6 March 2003 by the European Commission based on the quality,
safety and efficacy data submitted. These data included results
from more than 3,750 men representing a broad patient population.
The US Food and Drug Administration (FDA) approved Levitra
for the treatment of ED on 19 August 2003.
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