Tadalafil - Cialis ° 10 et 20
Un nouveau médicament pour traiter les troubles de l'érection
24/07/2002
Le Comité des spécialités pharmaceutiques (CPMP) de l'EMEA vient de donner un avis favorable pour l'octroi d'une autorisation de mise sur le marché (AMM) au nouveau médicament dénommé Cialis* (tadalafil).
Son principe actif est le tadalafil, un inhibiteur sélectif de la phosphodiestérase du type 5 (PDE-5), spécifique de la guanosine-monophosphate cyclique (GMPc). Il induit un relâchement du muscle lisse du corps caverneux, favorisant le flux sanguin vers le pénis, entraînant en même temps une érection.
Les laboratoires Lilly soulignent que Cialis a fait la preuve d’une efficacité dès la 16e minute et jusqu’à 24 heures après la prise, sans contrainte alimentaire. Son efficacité a été prouvée par plusieurs études qui révèlent que sous réserve d’une stimulation sexuelle, Cialis 20 mg améliore la fonction érectile chez 81% des patients contre 35% pour le placebo.
Les effets indésirables les plus fréquemment rencontrés sont les suivants : céphalée, dyspepsie, douleur au niveau du dos, myalgie, rhinite (congestion nasale), rougeur de la face.
L'indication approuvée est :" traitement des troubles de l'érection".
Esculape : A priori les CI et EI sont les mêmes que pour le Viagra ° - Sildénafil
Information complète avec Drugsoft.com : Cialis 10 et
Cialis 20
Le tadalafil est efficace dans le
traitement de la dysfonction érectile chez le diabétique
European Association for the Study of Diabetes & http://www.jim.fr
14 septembre 2001
Saenz de Tejada et coll. (Madrid) ont entrepris un travail destiné à évaluer
l’efficacité du tadalafil chez les patients diabétiques présentant des troubles de la fonction sexuelle modérés à
sévères. Le tadalafil est un nouvel inhibiteur sélectif des phosphodiesterase développé pour le traitement de la
dysfonction érectile (DE).
216 hommes (moyenne d’age 56 ans) avec un DE moyen à sévère et ayant un diabète de type 1 ou 2 ont été
inclus dans cette étude. Les patients ont été randomisés et ont reçu soit un placebo, soit10 mg, soit 20 mg de
tadalafil pendant 12 semaines. L’évaluation a été faite par l’Index of Erectil Function (IIEF) et le Sexual Encounter
Profil (SEP).
Une amélioration significative de ces items a ainsi pu être constatée chez les diabétiques traités
par tadalafil 10 mg et 20 mg. Les résultats sont indépendants du type de diabète, du traitement en cours, du taux
initial de la glycémie ainsi que des complications vasculaires préexistantes.
Les deux doses de tadalafil ont été
bien tolérées et aucun effets secondaires graves n’a été rapporté.
Les seuls effets indésirables relatés par plus
de 5% des patients ont été des maux de tête et des troubles dyspeptiques non doses dépendantes. Ces
résultats encourageants devront être confirmés par des études à plus grandes échelles.
Tadalafil, a new Phosphodiesterase-5 Inhibitor
for the
treatment of erectile dysfunction
Conférence de presse Lilly ICOS
Tadalafil is a new oral treatment for erectile dysfunction
being developed by Lilly ICOS LLC.
Tadalafil, a highly
selective Phosphodiesterase-5 (PDE-5) Inhibitor, works for up
to 24 hours and as early as 16 minutes after taking the pill.
The
effectiveness of tadalafil has been demonstrated in
placebo-controlled clinical studies involving 972 men with erectile dysfunction of
various causes and severity. Men were treated with tadalafil
(ranging up to 20 mg) or placebo for 12 weeks. Improved
erections, as assessed by the Global Assessment Questionnaire
(GAQ), were reported by 81 percent of patients taking 20 mg
tadalafil (35 percent placebo).
The positive treatment effect has
been shown not be affected by food intake. In the subset of men
with diabetes, tadalafil improved erections in 76 percent of taking
a 20 mg dose.
Tadalafil was well tolerated, with generally
mild-to-moderate side effects that diminished in frequency with
continued treatment. The most commonly reported side effects
throughout the Phase III trials were headache, upset stomach,
backache, muscle aches, flushing and nasal congestion.
Based on the data available, the good response rate, duration,
and tolerability of tadalafil give it the potential to become a
valuable treatment option for men with erectile dysfunction.
Tadalafil currently is under review for marketing approval by the
European Agency for the Evaluation of Medicinal Products
(EMEA) and the US Food and Drug Administration (FDA).
(supplied by Eli Lilly Austria)
============================================================
European Association for the Study of Diabetes
Tadalafil Shows Promise For The Treatment
of erectile dysfunction
In Diabetic Men
By David Jack, MD
Special to Doctor Guide News
Tadalafil has previously been shown to
be both safe and effective in non-diabetic men.
A small study
suggests that tadalafil appears to be safe and effective for the
treatment of diabetics men with erectile dysfunction.
Dr. Saenz de Tejada, from the Foundation for Andrological
Investigation and Development, in Madrid, Spain, presented the
results in type 1 and 2 diabetic men with mild-to-severe erectile
dysfunction .
A total of 216 men (mean age 56 years) with mild-to-severe erectile dysfunction
and
type 1 or type 2 diabetes were recruited. Baseline International
Index of Erectile Function (IIEF) scores were obtained and a Sexual
Encounter Profile (SEP) diary was kept during a four-week run in
period.
Patients were randomly allocated to placebo or tadalafil (IC351,
ICOS Corp., Bothell, USA), 10 or 20 mg, for a period of 12 weeks.
For inclusion, patients had to have experienced mild-to-severe ED
of psychogenic, organic or mixed cause for a period of three months
of more. The study end points were the percentage of "yes"
responses to a global assessment question (GAQ) and the change
in IIEF score compared with baseline.
Compared with placebo, tadalafil 10 mg and 20 mg produced a
significant increase (p<0.001) in patients’ ability to take part in
sexual activity as reflected in GAQ questions 1 and 2.
Tadalafil was also found to be better than placebo in improving
erectile function, as measured by the IIEF erectile function domain
score (p<0.001).
Both the 10 mg and 20 mg doses were also superior to placebo in
improving penetration ability (p<0.001), ability to maintain an
erection during intercourse (p<0.001) and in improving the IIEF
Intercourse Satisfaction domain scores (p=0.012) and Overall
Satisfaction domain scores (p<0.001).
Tadalafil 10 mg and 20 mg also increased the percentage of
successful sexual intercourse attempts as monitored by the Sexual
Encounter Profile. The magnitude of these increases ranged from
22 to 29 percent compared with -4 to 2 percent in the placebo
group. These differences were all highly significant (p<0.001).
The improvement in erectile function was seen irrespective of the
type of diabetes, current diabetic treatment, initial level of glycemic
control or presence of any microvascular complications.
Both doses of tadalafil were well tolerated and no serious
treatment-related adverse events were reported. The only
treatment-related events reported by more than 5 percent of the
participants were dyspepsia and headache.
Therefore, the researchers said, these
effects do not appear to be dose-related. There were no clinically
significant changes in laboratory parameters, electrocardiogram or
vital sings.
Although this is a very small study, the results suggest that tadalafil
is both safe and effective for the treatment of diabetics suffering
from erectile dysfunction
, the researchers concluded. These data need to be
confirmed in much larger trials, they added.
