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Safety and efficiency of Vesusten® for patients with overactive bladder
DOI: https://dx.doi.org/10.18565/urology.2022.3.42-51
D.Yu. Pushkar, Y.A. Kupriyanov, S.I. Gamidov, G.G. Krivoborodov, L.G. Spivak, S.Kh. Al-Shukri, D.M. Lerman, V.G. Gomberg, E.N. Bogdan, V.L. Shchukin, K.H. Chibirov, V.V. Gelashvili, А.К. Gural, N.G. Keshishchev, M.A. Staroselskaia, N.A. Bastrikova
1) A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of Russia, Moscow, Russia; 2) National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia, Moscow, Russia; 3) Pirogov Russian National Research Medical University, Moscow, Russia; 4) I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia, Moscow, Russia; 5) LLC «Family polyclinic No. 4», Moscow region, Korolev, Russia; 6) FGBOU VO Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg, Russia; 7) LLC «MK-Med», Saint Petersburg, Russia; 8) LLC «Chaika Clinics», Moscow, Russia; 9) GBUZ «City Geriatric Health Center», Saint Petersburg, Russia; 10) LLC «Aurora Medi», Saint Petersburg, Russia; 11) LLC «Research Center Eco-safety», Saint Petersburg, Russia; 12) FSBI «SPb NIIF» of the Ministry of Health of Russia, Saint Petersburg, Russia; 13) FSBI «Clinical Hospital № 85 FMBA», Moscow, Russia; 14) OGBUZ «Medical and sanitary unit No. 2», Tomsk, Russia; 15) FGBI «Joint Hospital and Polyclinic» Department of Presidential Affairs of the Russian Federation, Moscow, Russia; 16) PEPTIDPRO LLC, Moscow, Russia
Aim. To evaluate the efficiency and safety of Vesusten® (5 mg lyophilized powder for intramuscular injection in vial) compared to placebo in patients with overactive bladder (OAB).
Materials and methods: a multicenter, double-blind, randomized, placebo-controlled III phase clinical trial was carried out in accordance with GCP guidelines (Good Clinical Practice). The study consisted of three stages: a screening period (lasting 14 days, after which Visit 1 was carried out), a period for evaluating the efficiency of therapy (duration 42±5 days; Visit 2 was at 21±5 days with an assessment of the patient's health status, as well as Visit 3 at the end of period for evaluating efficiency), the observation period (lasting 28±2 days and ending with Visit 4 to monitor the patient’s condition and assess the safety of therapy using a telephone survey by the researcher).
Results: Vesusten® (5 mg) given 3 times a week intramuscularly resulted in pronounced effects: the average decrease in total of TUFS (Total Urgency and Frequency Score) was 1.97 times higher than in placebo group (p=0.0007), while the margin of superiority was
2.36 points (p=0.022). The daily number of urinary incontinence episodes decreased by 50% or more in 65.33% of patients compared to the baseline level (the difference with the placebo group was 24% by point estimates). The average number of urinary incontinence episodes in the group of Vesusten® decreased by 2.15 times compared to Placebo group.
Vesusten® effects were more pronounced at Visit 3 (3 weeks after stopping therapy) compared to Visit 2 (3-weeks of therapy), which may indicate that Vesusten® (product containing bioactive peptides derived from the bladder) triggers a cascade interfering with OAB pathogenetic pathways followed by the bladder function restoration. Vesusten® has a favorable safety profile. There were no serious adverse events (SAE), and there were no significant differences between the Vesusten® and placebo groups in other safety parameters evaluated in this study.
Conclusion. Our results suggest the favorable safety profile and the superiority of Vesusten® over placebo in terms of reducing OAB symptoms by TUFS (Total Urgency and Frequency Score) and reducing the number of incontinence episodes. A positive effect on patient’s quality of life was seen. Vesusten® is a promising effective and safe drug for the OAB treatment.
Materials and methods: a multicenter, double-blind, randomized, placebo-controlled III phase clinical trial was carried out in accordance with GCP guidelines (Good Clinical Practice). The study consisted of three stages: a screening period (lasting 14 days, after which Visit 1 was carried out), a period for evaluating the efficiency of therapy (duration 42±5 days; Visit 2 was at 21±5 days with an assessment of the patient's health status, as well as Visit 3 at the end of period for evaluating efficiency), the observation period (lasting 28±2 days and ending with Visit 4 to monitor the patient’s condition and assess the safety of therapy using a telephone survey by the researcher).
Results: Vesusten® (5 mg) given 3 times a week intramuscularly resulted in pronounced effects: the average decrease in total of TUFS (Total Urgency and Frequency Score) was 1.97 times higher than in placebo group (p=0.0007), while the margin of superiority was
2.36 points (p=0.022). The daily number of urinary incontinence episodes decreased by 50% or more in 65.33% of patients compared to the baseline level (the difference with the placebo group was 24% by point estimates). The average number of urinary incontinence episodes in the group of Vesusten® decreased by 2.15 times compared to Placebo group.
Vesusten® effects were more pronounced at Visit 3 (3 weeks after stopping therapy) compared to Visit 2 (3-weeks of therapy), which may indicate that Vesusten® (product containing bioactive peptides derived from the bladder) triggers a cascade interfering with OAB pathogenetic pathways followed by the bladder function restoration. Vesusten® has a favorable safety profile. There were no serious adverse events (SAE), and there were no significant differences between the Vesusten® and placebo groups in other safety parameters evaluated in this study.
Conclusion. Our results suggest the favorable safety profile and the superiority of Vesusten® over placebo in terms of reducing OAB symptoms by TUFS (Total Urgency and Frequency Score) and reducing the number of incontinence episodes. A positive effect on patient’s quality of life was seen. Vesusten® is a promising effective and safe drug for the OAB treatment.
About the Autors
Corresponding author: Yu.A. Kupriyanov – MD, PhD, Moscow State University of Medicine and Dentistry named after A.I. Evdokimov. Department of Urology, Moscow City Hospital named after S.I. Spasokukotsky, Moscow, Russia; e-mail: dr.kupriyanov@mail.ru
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