COMPARISON OF EFFICACY AND SAFETY OF DYNAMICO FORWARD, VIAGRA AND DYNAMICO IN MEN WITH ERECTILE DYSFUNCTION


Дәйексөз келтіру

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Аннотация

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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Рұқсат жабық

Авторлар туралы

A. Kamalov

Lomonosov Moscow State University

Medical 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 University

Medical Research and Educational Center; Department of Urology and Andrology of the Faculty of Fundamental Medicine

Әдебиет тізімі

  1. 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.
  2. Dadey E. Bioequivalence of 2 Formulations of Sildenafil Oral Soluble Film 100 mg and Sildenafil Citrate (Viagra) 100 mg Oral Tablets in Healthy Male Volunteers. Am. J. Ther. 2017; 24:e373-80.
  3. Bala R., Pawar P., Khanna S., Arora S. Orally dissolving strips: A new approach to oral drug delivery system. Int. J. Pharm. Investig. 2013;3:67-76.
  4. Selvin E., Burnett A.L., Platz, E.A. Prevalence and Risk Factors for Erectile Dysfunction in the US. Am. J. Med. 2007;120:151-57.
  5. Laumann E.O., Paik A., Rosen R.C. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281:537-44.
  6. Hatzimouratidis K., Amar E., Eardley I., et al.; European Association of Urology. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur. Urol. 2010; 58:804-14.
  7. Feldman H.A., Goldstein I., Hatzichristou D.G., et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J. Urol. 1994;151:54-61.
  8. Ludwig W., Phillips M. Organic Causes of Erectile Dysfunction in Men Under 40. Urol. Int. 2014;92:1-6.
  9. Grant P., Jackson G., Baig I., Quin J. Erectile dysfunction in general medicine. Clin. Med. 2013;13:136-40.
  10. McMurray J.G., Feldman R.A., Auerbach S.M., et al.; Multicenter Study Group. Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. Ther Clin. Risk Manag. 2007;3:975-81.
  11. Giuliano F., Jackson G., Montorsi F., Martin-Morales A., Raillard P. Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database. Int. J. Clin. Pract. 2010;64: 240-55.
  12. Dinsmore W.W., Hodges M., Hargreaves C., et al. Sildenafil citrate (viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Urology. 1999;53:800-5.
  13. Rendell M.S., Rajfer J., Wicker P.A., Smith M.D. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. JAMA. 1999;281:421-26.
  14. Sohi H., Sultana Y., Khar R.K. Taste Masking Technologies in Oral Pharmaceuticals: Recent Developments and Approaches. Drug Dev. Ind. Pharm. 2004;30:429-48.

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