Comparison of extended-release sildenafil with standard sildenafil in a randomized placebo-controlled study

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».