Efficacy and safety of the polypeptide drug «Vesusten» in the correction of neurogenic LUTS in multiple sclerosis. Results of the pilot study

Capa

Citar

Texto integral

Acesso aberto Acesso aberto
Acesso é fechado Acesso está concedido
Acesso é fechado Acesso é pago ou somente para assinantes

Resumo

Objective. The purpose of this study was to evaluate the effectiveness of the drugs Solifenacin and Vesusten in relation to the treatment of neurogenic bladder overactivity in multiple sclerosis (MS).

Materials and methods. A prospective, single-site, single-center, placebo-controlled, parallel-group, comparative clinical trial was conducted. The study included 41 MS patients of both sexes aged 18–50 years with urodynamically confirmed detrusor overactivity. Data were obtained by completing a voiding diary. Clinical data were assessed before taking the drugs, during a monthly course of therapy and after a month of observation after the end of treatment. The results were processed by nonparametric methods of statistical analysis.

Results. Both drugs are effective in patients with MS to correct neurogenic bladder overactivity. At the same time, in comparison with Solifenacin, Vesusten showed better clinical efficacy in relation to clinical manifestations of overactive bladder (OAB). Pollakiuria and urgency also decreased significantly. The best profile of maintaining the therapeutic effect was observed with Vesusten in relation to the frequency of urinary incontinence and OAB syndrome. The results of the study established that Solifenacin and Vesusten can cause adverse events, the frequency and nature of which correspond to the data declared by the manufacturers.

Discussion. Considering the clinical features of MS, the priority in treatment, in addition to effectiveness, is maximum conservative therapy.

The currently recommended therapy for neurogenic bladder overactivity is limited to the use of M-anticholinergics and intradetrusor administration of botulinum toxin type A drugs. At the same time, multiple side effects of such treatment are observed with a high frequency. The emergence of a new effective therapeutic agent is a promising direction for the treatment of neurogenic bladder overactivity in patients with MS.

Conclusions. Both Solifenacin and Vesusten are effective therapeutic options for the management of neurogenic bladder overactivity in MS. However, Vesusten has a more significant therapeutic profile, expressed in the correction of pollakiuria, urge incontinence and urgency. After completion of therapy, Vesusten, in comparison with Solifenacin, demonstrates the retention of a strong therapeutic effect. Based on the combination of various assessment parameters of a voiding diary, Vesusten is a priority therapeutic agent that determines the best quality of life profile for patients with MS.

Texto integral

Acesso é fechado

Sobre autores

Nemer M.N. Abdallah

Federal State Budgetary Educational Institution of Higher Education «Rostov State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: n_m2015@live.com
ORCID ID: 0009-0006-0252-2752

postgraduate student (PhD) of the Department of Urology and Human Reproductive Health (with a course of pediatric Urology-Andrology)

Rússia, Rostov-on-Don

I. Belousov

Federal State Budgetary Educational Institution of Higher Education «Rostov State Medical University» of the Ministry of Healthcare of the Russian Federation

Autor responsável pela correspondência
Email: belrost_dept@mail.ru
ORCID ID: 0000-0003-0674-9429

MD, Dr. Sci. (Med.), Professor of the Department of Urology and Human Reproductive Health (with a course of pediatric Urology-Andrology)

Rússia, Rostov-on-Don

M. Kogan

Federal State Budgetary Educational Institution of Higher Education «Rostov State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: kogan_dept@mail.ru
ORCID ID: 0000-0002-1710-0169

MD, Dr. Sci. (Med.), Professor. Chief of the Department of Urology and Human Reproductive Health (with a course of pediatric Urology-Andrology)

Rússia, Rostov-on-Don

Z. Goncharova

Federal State Budgetary Educational Institution of Higher Education «Rostov State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: centrms@mail.ru
ORCID ID: 0000-0001-7093-9548

MD, Dr. Sci. (Med.), professor of the Department of Nervous Diseases and Neurosurgery, Head of the Neurological Center

Rússia, Rostov-on-Don

M. Belousova

Federal State Budgetary Educational Institution of Higher Education «Rostov State Medical University» of the Ministry of Healthcare of the Russian Federation

Email: ivolga1@yandex.ru
ORCID ID: 0000-0001-5410-2115

MD, PhD, assistant of Department of anesthesiology and reanimatology

Rússia, Rostov-on-Don

Bibliografia

  1. Clinical recommendations of the Russian Federation 2022. Multiple sclerosis. Available at the link: https://diseases.medelement.com/disease/рассеянный-склероз-кр-рф-2022/17221 ?ysclid=lka4mw7cye32246934. Date of access: 04.04.24. Russian (Клинические рекомендации РФ 2022. Рассеянный склероз. Доступно по ссылке: https://diseases.medelement.com/disease/рассеянный-склероз-кр-рф-2022/17221?ysclid=lka4mw7cye32246934. Дата доступа: 04.04.24).
  2. Montalban X., Gold R., Thompson A.J., Otero-Romero S., Amato M.P., Chandraratna D. et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. Eur J Neurol. 2018;25(2):215–237. doi: 10.1111/ene.13536.
  3. Rae-Grant A., Day G.S., Marrie R.A., Rabinstein A., Cree B.A.C., Gronseth G.S. et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777–788. doi: 10.1212/WNL.0000000000005347.
  4. Andreeva M.T., Karavaeva T.A. Concomitant mental disorders and impaired emotional regulation in patients with multiple sclerosis. Review of Psychiatry and Medical Psychology named after V.M. Bekhterev. 2019;4-2:19-28. Russian (Андреева М.Т., Караваева Т.А. Сопутствующие психические расстройства и нарушение эмоциональной регуляции у пациентов с рассеянным склерозом. Обозрение психиатрии и медицинской психологии имени В.М. Бехтерева. 2019;4-2:19-28).
  5. Boynova I.V., Samarina D.V., Katorova A.V., Tokareva N.G. Clinical and epidemiological features of multiple sclerosis in the Russian Federation. Modern problems of science and education. 2022;5. doi: 10.17513/spno.32006. Russian (Бойнова И.В., Самарина Д.В., Каторова А.В., Токарева Н.Г. Клинико-эпидемиологические особенности рассеянного склероза в Российской Федерации. Современные проблемы науки и образования. 2022;5. doi: 10.17513/spno.32006).
  6. Katz Sand I. Classification, diagnosis, and differential diagnosis of multiple sclerosis. Curr Opin Neurol. 2015;28(3):193–205. doi: 10.1097/WCO.0000000000000206. PMID: 25887774.
  7. Sakakibara R. Neurogenic lower urinary tract dysfunction in multiple sclerosis, neuromyelitis optica, and related disorders. Clin Auton Res. 2019;29(3):313-320. doi: 10.1007/s10286-018-0551-x.
  8. Castel-Lacanal E., Gamé X., Clanet M., Gasq D., De Boissezon X., Guillotreau J. et al. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015;34(1):32–36. doi: 10.1002/nau.22495.
  9. Zecca C., Riccitelli G.C., Disanto G., Singh A., Digesu G.A., Panicari L. et al. Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients’ quality of life. Eur J Neurol. 2016;23(7):1228–1234. doi: 10.1111/ene.13010.
  10. Nazari F., Shaygannejad V., Mohammadi Sichani M., Mansourian M., Hajhashemi V. The prevalence of lower urinary tract symptoms based on individual and clinical parameters in patients with multiple sclerosis. BMC Neurol. 2020;20(1):24. doi: 10.1186/s12883-019-1582-1.
  11. Ziadeh T., Mjaess G., El Helou J., Zalaket J., Mouawad C., Azar C. et al. Impact on quality of life in multiple sclerosis patients: Which urinary symptoms are to blame? Prog Urol. 2022;32(10):711-716. doi: 10.1016/j.purol.2022.05.003.
  12. Stankovich E.Y. Disorders of the urodynamics of the lower urinary tract in patients with multiple sclerosis. Diagnosis and treatment: abstract of the dissertation of the Candidate of Medical Sciences, M., 2006, 130 p. Russian (Станкович Е.Ю. Нарушения уродинамики нижних мочевых путей у больных рассеянным склерозом. Диагностика и лечение: автореф… дисc. канд. мед. наук. М., 2006, 130 с.).
  13. Zyryanov A.V., Bazhenov I.V., Filippova E.S., Ustinov G.S., Turova E.L., Toreev I.O., Leushin E.K. Epidemiology and nature of urination disorders in patients with multiple sclerosis. Bulletin of Urology. 2020;8(2):29–36. https:// doi.org/10.21886/2308-6424-2020-8-2-29-36. Russian (Зырянов А.В., Баженов И.В., Филиппова Е.С., Устинов Г.С., Турова Е.Л., Тореев И.О., Леушин Е.К. Эпидемиология и характер расстройств мочеиспускания у больных рассеянным склерозом. Вестник урологии. 2020;8(2):29–36. https:// doi.org/10.21886/2308-6424-2020-8-2-29-36).
  14. Aharony SM, Lam O, Corcos J. Evaluation of lower urinary tract symptoms in multiple sclerosis patients: Review of the literature and current guidelines. Can Urol Assoc J. 2017;11(1-2):61–64. doi: 10.5489/cuaj.4058.
  15. Sparaco M., Bonavita S. Pelvic Floor Dysfunctions and Their Rehabilitation in Multiple Sclerosis. J Clin Med. 2022;11(7):1941. doi: 10.3390/jcm11071941.
  16. Phé V., Chartier-Kastler E., Panicker J.N. Management of neurogenic bladder in patients with multiple sclerosis. Nat Rev Urol. 2016;13(5):275-288. doi: 10.1038/nrurol.2016.53142, 285.
  17. Clinical recommendations. Neurogenic dysfunction of the lower urinary tract. Available at the link: https://ooorou.ru/upload/iblock/36b/KR_NDNMP-2023.pdf . Date of access: 04.04.2024. Russian (Клинические рекомендации. Нейрогенная дисфункция нижних мочевыводящих путей. Доступно по ссылке: https://ooorou.ru/upload/iblock/36b/KR_NDNMP-2023.pdf. Дата доступа: 04.04.2024).
  18. Decree of the Government of the Russian Federation dated 12.10.2019 No. 2406-r (ed. dated 12/24/2022) https://www.consultant.ru/document/cons_doc_LAW_335635/9eafb39fff8190c66b51355b212e9af18073c8d4/. Date of access: 04.04.2024. Russian (Распоряжение Правительства РФ от 12.10.2019 N 2406-р (ред. от 24.12.2022) <Об утверждении перечня жизненно необходимых и важнейших лекарственных препаратов, а также перечней лекарственных препаратов для медицинского применения и минимального ассортимента лекарственных препаратов, необходимых для оказания медицинской помощи. Доступно по ссылке: https://www.consultant.ru/document/cons_doc_LAW_335635/9eafb39fff8190c66b51355b212e9af18073c8d4/. Дата доступа: 04.04.2024).
  19. Nicholas R.S., Friede T., Hollis S., Young C.A. WITHDRAWN: Anticholinergics for urinary symptoms in multiple sclerosis. Cochrane Database Syst Rev. 2015;2015(6):CD004193. doi: 10.1002/14651858.CD004193.pub3.
  20. Fonseca A.M., Meinberg M.F., Monteiro M.V., Roque M., Haddad J.M., Castro R.A. The Effectiveness of Anticholinergic Therapy for Overactive Bladders: Systematic Review and Meta-Analysis. Rev Bras Ginecol Obstet. 2016;38(11):564-575. doi: 10.1055/s-0036-1594289.
  21. Stoniute A., Madhuvrata P., Still M., Barron-Millar E., Nabi G., Omar M.I. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
  22. Abrams P., Andersson K.E., Buccafusco J.J., Chapple C., de Groat W.C., Fryer A.D. et al. Muscarinic receptors: their distribution and function in body systems, and the implications for treating overactive bladder. Br J Pharmacol. 2006;148(5):565–578. doi: 10.1038/sj.bjp.0706780.
  23. Bridgeman MB, Friia NJ, Taft C, Shah M. Mirabegron: β3-adrenergic receptor agonist for the treatment of overactive bladder. Ann Pharmacother. 2013;47(7–8):1029–1038. doi: 10.1345/aph.1S054.
  24. Szczurowska E, Szánti-Pintér E, Chetverikov N, Randáková A, Kudová E, Jakubík J. Modulation of Muscarinic Signalling in the Central Nervous System by Steroid Hormones and Neurosteroids. Int J Mol Sci. 2022;24(1):507. doi: 10.3390/ijms24010507
  25. Rocca M.A., Amato M.P., De Stefano N., Enzinger C., Geurts J.J., Penner I.K. et al. MAGNIMS Study Group. Clinical and imaging assessment of cognitive dysfunction in multiple sclerosis. Lancet Neurol. 2015;14(3):302–317. doi: 10.1016/S1474-4422(14)70250-9.
  26. Dhanapalaratnam R., Markoulli M., Krishnan A.V. Disorders of vision in multiple sclerosis. Clin Exp Optom. 2022;105(1):3–12. doi: 10.1080/08164622.2021.1947745.
  27. Instructions for use of Solifenacin. Available at the link https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=790a736a-1e12-4954-b8e2-6446c814ce70 . Date of application 04.04.24. Russian (Инструкция по применению Солифенацина. Доступно по ссылке https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=790a736a-1e12-4954-b8e2-6446c814ce70. Дата обращения 04.04.24).
  28. Instructions for the use of Vesusten. Available at the link https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=eb3ebc7f-4c4e-40d5-a200-c89b3eed6bab . Date of application 04.04.24. Russian (Инструкция по применению Везустена. Доступно по ссылке https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=eb3ebc7f-4c4e-40d5-a200-c89b3eed6bab. Дата обращения 04.04.24).
  29. Kurtzke J.F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33(11):1444–1452. doi: 10.1212/wnl.33.11.1444.
  30. Collins C.D., Ivry B., Bowen J.D., Cheng E.M., Dobson R., Goodin D.S. et al. A comparative analysis of Patient-Reported Expanded Disability Status Scale tools. Mult Scler. 2016;22(10):1349–1358. doi: 10.1177/1352458515616205
  31. Zillioux J, Welk B, Suskind AM, Gormley EA, Goldman HB. SUFU white paper on overactive bladder anticholinergic medications and dementia risk. Neurourol Urodyn. 2022;41(8):1928-1933. doi: 10.1002/nau.25037.
  32. Borisov V., Demina T., Stankovich E.Yu., Gadzhieva Z.K. Diagnosis of lower urinary tract dysfunction and symptomatic treatment of bladder hyperreflexia in patients with multiple sclerosis. All-Russian Congress of Neurologists. Kazan, May 21-24, 2001. Collection of abstracts. pp.57-59. Russian (Борисов ВВ., Демина ТЛ., Станкович Е.Ю., Гаджиева З.К. Диагностика нарушений функции нижних мочевых путей и симптоматическое лечение гиперрефлексии мочевого пузыря у больных рассеянным склерозом. Всероссийский съезд неврологов. Казань, 21–24 мая, 2001. Сборник тезисов. С. 57–59).
  33. FDA Approved label OnabotulinumtoxinA (BOTOX®) [Доступно по ссылке: Botox Label (fda.gov), дата доступа: 07.07.2023].
  34. Cheng T., Shuang W.B., Jia D.D., Zhang M., Tong X.N., Yang W.D. et al. Efficacy and Safety of Onabotulinumtoxin A in Patients with Neurogenic Detrusor Overactivity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS One. 2016 Jul 27;11(7):e0159307. doi: 10.1371/journal.pone.0159307
  35. European Association of Urology Guidelines on Neuro-urology. EAU Guidelines. 2023. Доступно по ссылке https://uroweb.org/guidelines/neuro-urology/chapter/the-guideline. Дата доступа: 04.04.24.
  36. Krhut J, Skugarevská B, Míka D, Lund L, Zvara P. Clinical Utility of β3-Adrenoreceptor Agonists for the Treatment of Overactive Bladder: A Review of the Evidence and Current Recommendations. Res Rep Urol. 2022;14:167-175. doi: 10.2147/RRU.S309144
  37. Pushkar D.Yu., Gamidov S.I., Gomberg V.G., Gural A.K., Evdokimov M.S., Kasyan G.R., Kuzmin I.V., Ryzhak G.A., Spivak L.G. Vesustim: the first results of application in a clinical trial in patients with overactive bladder. Experimental and Clinical Urology 2020;(3):34–35. https://doi.org/10.29188/2222-8543-2020-12-3-34-35. Russian (Пушкарь Д.Ю., Гамидов С.И., Гомберг В.Г., Гураль А.К., Евдокимов М.С., Касян Г.Р., Кузьмин И.В., Рыжак Г.А., Спивак Л.Г. Везустим: первые результаты применения в рамках клинического исследования у пациентов с гиперактивным мочевым пузырем. Экспериментальная и клиническая урология 2020;(3):34–35. https://doi.org/10.29188/2222-8543-2020-12-3-34-35).
  38. Pushkar D.U., Kupriyanov, Gamidov S.I., Krivoborodov G.G., Spivak L.G., Al-Shukri H.S., etc. Evaluation of the safety and efficacy of the drug Vesusten® in patients with overactive bladder. Urologiia. 2022;3:42–51. Russian (Пушкарь ДЮ, КуприяновЮА, Гамидов СИ, Кривобородов ГГ, Спивак ЛГ, Аль-Шукри ХС и др. Оценка безопасности и эффективности лекарственного препарата Везустен® у пациентов с гиперактивным мочевым пузырем. Урология. 2022;3:42–51).
  39. Resolution of the Expert Council «Current prospects for pathogenetic therapy of overactive bladder syndrome/urinary incontinence. The first-year experience of using the drug Vesusten». Urologiia. 2023;5:136–138. https://dx.doi.org/10.18565/urology.2023.5.136-138. Russian (Резолюция экспертного совета «Перспективы патогенетической терапии гиперактивного мочевого пузыря/недержания мочи в современных реалиях. первый год применения препарата Везустен». Урология. 2023;5:136–138. https://dx.doi.org/10.18565/urology.2023.5.136-138).

Arquivos suplementares

Arquivos suplementares
Ação
1. JATS XML
Baixar
2. Fig. 1. Schematic representation of the procedures of the clinical protocol

Baixar (138KB)
Metadados
3. Fig. 2. Comparative analysis of the side effects of Solifenacin (A) and Vesustene (B)

Baixar (157KB)
Metadados

Declaração de direitos autorais © Bionika Media, 2024

Este site utiliza cookies

Ao continuar usando nosso site, você concorda com o procedimento de cookies que mantêm o site funcionando normalmente.

Informação sobre cookies