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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)

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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.
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