COMPARISON OF EFFICACY AND SAFETY OF DYNAMICO FORWARD, VIAGRA AND DYNAMICO IN MEN WITH ERECTILE DYSFUNCTION
- Autores: Kamalov A.A1, Spivak L.G2, Okhobotov D.A1
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Afiliações:
- Lomonosov Moscow State University
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Edição: Nº 6 (2018)
- Páginas: 74-79
- Seção: Articles
- URL: https://journals.eco-vector.com/2073-4034/article/view/295370
- ID: 295370
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Resumo
Background. Bioequivalence studies of the of sildenafil orally dissolving films show similar plasma concentrations of the active substance compared to tableted forms of the same preparation [1-3], while there are no comparative studies of the therapeutic equivalence of sildenafil orally dissolving films and tableted forms of this drug. Objective. Evaluation of the clinical efficacy and safety of Dynamico Forward (orally dissolving films) in comparison with Viagra and Dynamico in patients with erectile dysfunction (ED). An additional object was to evaluate the efficacy and safety of Dynamico in comparison with Viagra in patients with ED. Methods. The study involved 120 men with ED aged 20 to 70 years who had a total score of 11-25 in the erectile function domain of the ICEF (International Index of Erectile Function). The treatment lasted 12 weeks. Results. The frequency of positive treatment responses in the study groups at the final visit was 55% in the Viagra group, 75% in the Dynamico group, and 70% in the Dynamic Forward group. In all three groups, a statistically significant increase in the quality of sexual life was recorded at visits 3 and 5 compared to baseline, while Dynamico Forward showed clinical efficacy comparable to that of Dynamico and Viagra. There were no significant differences in the safety and the tolerability of therapy between the groups. Conclusion. The study results confirmed comparable therapeutic efficacy of Dynamico Forward and Dynamico, as well as Dynamico Forward and Viagra, with satisfactory tolerability and safety of the use of all three studied drugs.
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Sobre autores
A. Kamalov
Lomonosov Moscow State UniversityMedical Research and Educational Center; Department of Urology and Andrology of the Faculty of Fundamental Medicine
L. Spivak
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Email: Leonid.Spivak@gmail.com
PhD, associate Professor in the Department of Urology
D. Okhobotov
Lomonosov Moscow State UniversityMedical Research and Educational Center; Department of Urology and Andrology of the Faculty of Fundamental Medicine
Bibliografia
- Radicioni M., Castiglioni C., Giori A., et al. Bioequivalence study of a new sildenafil 100 mg orodispersible film compared to the conventional film-coated 100 mg tablet administered to healthy male volunteers. Drug Des. Devel. Ther 2017;11:1183-92.
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