6
ESSM
Today
Highlights from the “ESSM Meeting Istanbul”
Different surgical approaches employed in
prosthetic reservoir placement
by Dr Marco Spilotros and Dr David Ralph,
from the United Kingdom as an updated topic;
because patients who demand penile implant
surgery are more complex everyday.
Sponsored Symposia
Avanafil: A new treatment to meet your ED
patients need
Speakers:
Vincenzo Mirone (Italy), François
Giuliano (France), John P Mulhall (USA).
Important advances in the field of treatment of
erectile dysfunction were presented, with the
launch and presentation at European level of
Avanafil, a new inhibitor of phosphodiesterase
type 5 (PDE5 inhibitor), which will be marketed
by Menarini Group.
Avanafil is a PDE5 inhibitor with a fast and highly
selective action, approved by the Food and Drug
Administration (FDA) for the treatment of erectile
dysfunction in April 2012, and recently approved
in the European Union. It will be marketed under
the name of Spedra, and will be available in
doses of 50, 100 and 200 mg.
Avanafil strongly inhibits PDE5 in a competitive
manner. The drug is more potent (100 fold) and
show higher selectivity (120 fold) for PDE5 and
for PDE6 than sildenafil (16 fold) and Vardenafil
(21 fold); and its selectivity for PDE5 versus
PDE1 is greater than 10 000 fold (sildenafil
380 fold and Vardenafil 1000 fold). In contrast
to Tadalafil, considerable inhibition by Avanafil
of PDE 11 was not registered.
Avanafil compared with other PDE5 inhibi-
tors available, has a unique selectivity profile,
which results in a rapid onset of action and
an increase in potency that allows patients to
maintain satisfactory sexual intercourse within
15 minutes after administration of the drug,
improving the spontaneity of sexual activity. Ad-
verse effects are mostly mild to moderate in
nature. Moreover Avanafil had significantly lower
rates of hemodynamic side effects and shorter
duration of interaction in combination with NO-
releasing drugs, become in a suitable medication
for patients with ED who taking nitrates.
Premature ejaculation: Treating a highly im-
pacting multidimensional condition
(Sponsored by Menarini Group).
Speakers:
Emmanuele A Jannini (Italy), Stanley
Althof (USA), Andrea Burri (United Kingdom),
Cris Mc Mahon (Australia)
Recent advances, in the field treatment of pre-
mature ejaculation (PE), were presented. The
results of the PAUSE study were discussed; a
prospective, observational, multicenter study
conducted in 7 European countries, with a
duration of 12 weeks; whose objective was
to evaluate the safety profile and adverse ef-
fects (AEs) in 6712 patients treated with 30-
60 mg Dapoxetine (group A) vs. 3316 treated
with other standard treatment options (group
B), involving long half-life SSRIs (n = 1515),
topical therapy (n = 952), condoms (n = 432),
behavioral therapy (n = 1182) and other treat-
ments (n = 362).
The study concluded that in both groups,
treatment was well tolerated, with 12% of AEs
reported in group A and 8.9 % in group B,
which increase in patients older than 65 years
(21.4%). The most common adverse effects
were nausea, headache and dizziness and in a
higher proportion in group A, although they did
not reach 5%. No cases of syncope in group
A and one case of syncope in group B were
reported. In treatment group A, 58 patients
(0.9 %) were taking some medications contrain-
dicated during the course of the study (usu-
ally antidepressants) and 540 patients (8.8%)
were taking treatment with some type of caution
about its use (PDE5 inhibitors, alpha blockers).
The total number of patients experiencing at
least one adverse event was higher in the group
of patients treated with Dapoxetine, especially
in patients who increased the dose from 30 to
60 mg over the course of the study, compared
with patients who maintained the 30mg dose.
Twelve (0.2 %) severe AEs in group A and 10
(0.3 %) in group B were reported; however,
none of these events were considered related
to treatment.
The dropout rate was 1.5% in group A and
0.2 % in group B, most relating to AEs; how-
ever, 0.3 % of patients discontinued treatment
despite not having reported any AE. Although
the proportion of AEs was slightly higher in the
group of Dapoxetine, is important to note that
more than two thirds of patients in group B were
treated with behavioral therapy or topical treat-
ments, which have no systemic adverse effects.
The results of this observational study dem-
onstrated that Dapoxetine has a good safety
profile and low prevalence of AEs. The high
level of adherence by healthcare providers
to the contraindications, special warnings,
and precautions for Dapoxetine minimizes
the risk for its use in routine clinical practice.
Dapoxetine in doses of 30 mg and 60 mg has
shown to be superior to placebo in all efficacy
variables. Efficacy results were similar in both
individual analysis and the combined analysis
of the studies, which concluded that Dapox-
etine is “consistently” superior than placebo,
regardless of the demographic characteristics
of the patients.
Posters
In the conference facilities, a great amount of
posters were exhibited, including some which
aroused great interest:
New highlights for postorgasmic syndrome
presented by Dr Juan Ignacio Martinez-Sala-
manca et al, from Spain; based on a survey in a
virtual forum. New approaches suggest that this
syndrome may be defined as neurobiochemis-
try sequel related to orgasm, to generate new
treatment hypotheses.
