Question:
New York - Vardenafil, a phosphodiesterase-5 (PDE-5) inhibitor, has been
shown to improve erections in up to 80% of men and increase their ability to
complete sexual intercourse with ejaculation, according to a presentation at
the XVI annual European Association of Urology (EAU) meeting in Geneva,
Switzerland. The study was the first large-scale patient trial of
vardenafil, which is made by Bayer.
"Vardenafil improved erectile function in these men, regardless of their
age, cause, or severity of their problem. This improvement occurred even at
the lowest dose of 5 mg," said Dr. Irwin Goldstein, Boston University School
of Medicine, a co-author of the study and a member of the international
Vardenafil Study Group. "There was another important finding as well,"
continued Goldstein. "In the overall study, vardenafil not only helped most
men achieve erections, they also were able to sustain their erections and
successfully complete intercourse."
The analyses involved 580 patients, aged 21-70 years, in stable heterosexual
relationships, from 39 treatment centers in the United States, Belgium,
France, Germany, the Netherlands, Poland, and South Africa. The patients had
experienced difficulty with erectile function of organic, psychogenic, or
mixed etiology for an average of 2.8 years. They were randomized into 4
groups and received vardenafil in 5 mg, 10 mg, 20 mg doses, or placebo on
demand, but not more than once a day.
In subanalyses, effects of vardenafil were evaluated by patients' responses
to 2 key questions of the International Index of Erectile Function (IIEF)
questionnaire: the ability to penetrate (question 3 [Q3]) and the ability to
maintain an erection during intercourse (question 4 [Q4]). The scoring was
based on a 5-point scale, with one being the most severe.
Those with a baseline Q3 score of 1.0 (ie, with very little ability to
penetrate) increased their score to a mean of 1.8 with placebo and to 3.0,
3.1, and 3.7 with 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Those
with a starting score of 4.0 on Q3 deteriorated to a mean score of 3.4 with
placebo, but increased to a mean of 4.4, 4.7, or 4.4 for the same increasing
doses of vardenafil.
For Q4, the results were similar. Those with a score of 1.0 (ie, with very
little ability to maintain an erection and complete intercourse) increased
their score to a mean of 2.0 with placebo and to scores of 3.3, 3.1, and 3.5
with increasing doses of vardenafil. Those with a relatively mild degree of
severity starting with a score of 4.0 had a decreased mean of 3.6 on
placebo, but reached a score of 4.0, 4.3, or 4.7 with increasing doses of
vardenafil.
Having an organic or psychogenic etiology of erectile dysfunction did not
influence the efficacy of vardenafil. The mean changes in score of Q3 for
organic and psychogenic erectile dysfunction were: 0.3 and 0.3 for placebo,
1.2 and 1.4 for 5 mg, 1.5 and 1.1 for 10 mg, and 1.3 and 1.4 for 20 mg doses
of vardenafil, respectively. Similar responses were seen for Q4.
The patients were divided into 4 age groups: younger than 45 years, 45-55
years, 55-65 years, and older than 65 years. For Q4, the mean increases in
score for placebo-treated patients ranged between 0.2 and 0.8 in each age
group. For vardenafil-treated patients, a statistically significant
treatment effect was found for all doses with mean increases ranging between
0.8 and 1.9, but no one age group had a superior response to vardenafil.
"Our study also demonstrated that vardenafil was well tolerated, with few
patients reporting any adverse events," Dr. Goldstein reported. The most
frequent adverse events, whether related to the drug or not, were headache
(7-15%), flushing (10-11%), rhinitis (3-7%), and dyspepsia (1-7%). The
events were generally mild in intensity and related to dosage.
In preclinical studies, the pro-erectile activity of vardenafil was greater
than sildenafil at equivalent dosing. In a separate study, vardenafil was
found to be highly selective at targeting the PDE-5 enzyme, which is
believed to be responsible for inducing erections. Vardenafil is now being
evaluated in Phase III trials to better understand if these characteristics
will translate into clinical benefits for patients. Results are expected for
publication later this year, with completion of the Food and Drug
Administration (FDA) review in the second half of 2002. Current estimates
suggest that more than half of all men in the United States older than 40
years experience some difficulty with erectile function.
Any suggestion?
Answer:
This is the first I've read of Vardenafil. Do you know if this is the stuff
being loosely referred to (on the net) as the "Viagra alternative?" (And
no, I'm not referring to scam, spam or "natural" products.) And if you have
another link further detailing the drug and the side effects, I'd appreciate
it if you'd post it for me. I'll check out the Bayer site.
Mine is the DH who can take as little as 25mg Viagra (with predictable
success) after eating a high fat meal but suffers side effects regardless of
dosage. Fewer side effects might mean a greater willingness to take
advantage of opportunities ;-) on my DH's part ... something which would
please me greatly
