Preliminary data about a comparison among
the different E1 Prostaglandins used for
intracavernous autoinjective therapy
of impotence.
Authors: Giorgio Cavallini*,
Paolo Michele Giorgi**,
Giulio Biagiotti***
*ANDROS - ITALIA: Sede di Ferrara*, Sede di Lucca**,
Sede di Perugia***
Key words: E1 Prostaglandin, Caverject, Viridal.
ABSTRACT
E1 prostaglandin (PGE1) has become the main drug
for erectile impotence since 1987.
Liquid phase PGE1 had been used till recent years
when two different liophilic PGE1 have been marketed:
Caverject (Pharmacia-Upjohn) in 1996 and Viridal
(Schwartz) in 1997. These drugs are different in terms
liophilization technique: Caverject is included in
lactose - Na citrate, while Viridal is included in
alphacyclodestrin.
This research is aimed to detect whether significant
differences exists in terms of efficacy, safeness,
and results reproducibility from among the different PGE1.
It collects oggetive data obtained under strict laboratory
(i.e. outpatient clinic) conditions with
double - blind cross - over experimental planning:
a standardized (10 mcg) amount of each PGE1 has been
intracavernously injected, increases in penile tumescence
and circumference have been measured with real - time
Rigiscan, differences have been compared. This research
has been divided in 2 steps: the first (46 patients)
compared Caverject and Viridal efficency and side effects;
the second (16 patients) evalued climate
(hot or cold season) interference with PGE1
performances.
Our data indicate that Viridal proved more active,
less influenced by climate and better tolerated than
Caverject, these differences proved due to inclusion
technique, a lower importance should ascribed to techniques
which inhibits PGE1 absorbtion to syringe (i.e.: siliconated
teflon syringes, or 0.9% benzilic alcohol - water solution).
IN PRESS
Verapamil in the therapy of arterial impotence in
Peyronie’ s disease
AUTHORS:
1 Giorgio Cavallini M.D., Andros Italia, Ferrara
2 Giulio Biagiotti M.D., Andros Italia, Perugia
3 Domenico Canale M.D. University of Pisa
4 Paolo Michele Giorgi M.D., Andros Italia, Lucca
5 Diego Pozza M.D., Andros Italia, Roma
KEY WORDS: Arterial impotence, verapamil, Peyronie’ s disease.
SUMMARY
Arterial impotence due to atherosclerosis is present
in a minority of patients with Peyronie’ s disease,
and needs prothesis implantation. This paper presents
the effects of an alternative treatment to surgery to
restore sexual potency in these subjects, i.e.:
intralesional verapamil.
20 patients affected by Peyronie’ s disease and
atherosclerotic arterial erectile failure were studied.
Sex-life satisfaction plus international index of
erectile function (IIEF 15) questionnaire scorage
plus right and left cavernous and dorsal artery peak
flow velocity after intracavernous administration
of PGE1 were compared before, and 6 months after
therapy with randomized block analysis of variance.
Side effects were also recorded.
8 patients (40%) proved fully satisfied, 3 (15%)
moderately and 9 (45%) dissatsfied with their
sexual life after this treatment which further
proved to significantly increase the IIEF 15 score of
orgasm, erectile function, sexual intercourse satisfaction,
sexual desire and general wellbeing and to augment
significantly the peak flow velocity in all the studied
penile arteries. Side effects proved negligeable.
These data led us to conclude that intraplaque verapamil
injections might be a useful method to resolve erectile
failure secondary to atherosclerotic disease of penile
arteries in Peyronie’ s patients, in addition since
only scattered side effects emerged from verapamil use,
it should be regarded as a safe tool
as well.
In press
ACETYL–L–CARNITINE (ALC) VERSUS TAMOXIFEN (T) IN
THE THERAPY OF PEYRONIE’ S DISEASE.
*Giulio Biagiotti, **Giorgio Cavallini,
***Paolo Michele Giorgi. *ANDROS – ITALIA,
Outpatient Clinic of Perugia, via Martiri dei
Lager 56, 06128 Perugia (ITALY);
**ANDROS – ITALIA, Outpatient Clinic of Ferrara,
via Mascheraio 46, 44100 Ferrara. (ITALY).
***ANDROS – ITALIA, Outpatient Clinic of Lucca,
Via Sarzanese 2063, 55100 Lucca (ITALY).
Peyronie’ s disease is a two step flogistic disease
of poorly known etiology involving tunica albuginea
and/or itracavernous septum of the penis: first stage
is acute and the second is chronic resulting in scars,
and/or penile curving. These patterns are steady while
its duration, extent and seriousness are irregular. Oral
therapy has proved to be of some help in acute and first
chronic phases of disease, thus a number of drugs
have been proposed. This paper compares oral ALC versus T,
up to now reputed the most active oral drug. ALC is a
drug used untill now in degenerative and flogistic diseases.
48 patients (15 acute and 33 initial chronic phase,
mean age 52 years, age range 24-64) were studied
and randomized in two groups of 24: the 1st group
used tamoxifen 20x2 mg/day for 3 months, the 2nd used
ALC 1x2 g/day for 3 months. Disease diagnosis and
stadiation were made with: anamnesis, physical
exhamination, pharmaco-induced erection
(intracavernous E1 prostaglandin 10 cg),
autophotography in erection, basic
and dynamic (intracavernous E1 prostaglandin 8
mcg) echo-color-doppler. Associated pathology was
diabetes in 11 cases,
Dupuytren’s disease in 2. The differences
in success and
side effects ratio between the groups were
analyzed with chi square tests.
ALC proved active in 22 patients (91.7%),
T in 11 (45.8%) (chi square=9.69, p<0.01);
T induced side effects in 6 patients (20%:
3 patients referred cutaneous rashes, 2 loss
of libido and 1 epigastralgia), ALC in none
(0%) (chi square=4.76, p<0.05).
These data allowed us to conclude that
ALC proved significantly more active and
safe than tamoxifen in the therapy of acute
and initial chronic phase of Peyronie’s disease.
No specific biochemical study was
performed to ascertain the ALC mechanism of
action in Peyronie’ s disease, however it is
known that this drug proved able to: reduce free
radical production, lower leukotrien, thromboxane
and prostaglandin production, stabilize cell
and mitochondria membrane, increase
Kreb’ s cycle, increase histamine catabolism.
In any case more studies are needed to
ascertain whether ALC might be of
some help when associated with other
non-surgical therapeutic approaches
to Peyronie’ s.