Urologiia. 2024 Dec;(6):45-52.
ABSTRACT
INTRODUCTION: Sildenafil citrate (Viagra) is widely used to treat erectile dysfunction (ED). However, this drug is associated with high frequency of adverse events such as headaches and cardiovascular disorders. «Vildegra» is a sildenafil encapsulated in hypromellose, which provides a slow release of the substance and a longer duration of action (13 hours vs. 4 hours). This may reduce the incidence of such effects.
AIM: To prove that Vildegra 50 mg has non-inferior efficiency compared to Viagra 50 mg, but is associated with better tolerability and greater safety.
MATERIALS AND METHODS: A triple-arm crossover open placebo-controlled randomized clinical trial was carried out in accordance with the protocol and all ethical principles. Patients were men aged 19-60 years with a diagnosis of ED. Patients received Vildegra as monotherapy within 4 weeks, followed by a week of a «washout» period, 4 weeks of placebo, another week of a «washout» period, then 4 weeks of Viagra. In the control group, the sequence of drugs was as following: Viagra — placebo — Vildegra.
RESULTS: «Vildegra» increased sexual activity 1.6 times more than «Viagra» and 2.4 times more than placebo. At the same time, there were no significant changes in the IIEF-5 score between «Vildegra» and «Viagra». The initial IIEF-5 score was 14+/-3.8 and 13.9+/-3.5, respectively, while after 1 month of therapy it improved to 20.9+/-3 and 20+/-3.4, respectively (p=0.678). The frequency of adverse events of «Vildegra» was 1.6 times lower compared to «Viagra». At the end of therapy, no negative impact on laboratory and clinical parameters was documented.
CONCLUSION: «Vildegra» is not inferior to «Viagra» in efficiency and has better tolerability, which resulted in the higher frequency of on-demand use of «Vildegra».
PMID:40377551
