Possibilities of using Urorek® (silodosin, 8 mg) for empirical therapy in patients with lower urinary tract symptoms due to benign prostatic hyperplasia: results of the Russian multicenter observational study MERCURY

Мұқаба
  • Авторлар: Pushkar D.Y.1,2, Bernikov A.N.1,2, Shvedov A.M.2, Zyryanov A.V.3,4, Feofilov I.V.5, Igoshkin A.V.5,6, Medvedev V.L.7,8, Efremov M.E.7,8, Komyakov B.K.9,10, Fadeev V.A.9
  • Мекемелер:
    1. FGBOU VO «Russian University of Medicine», Ministry of Health of the Russian Federation
    2. S.P. Botkin Moscow Multidisciplinary Clinical and Research Center
    3. Ural State Medical University, Ministry of Health of the Russian Federation
    4. Sverdlovsk Regional Clinical Hospital No. 1
    5. Novosibirsk State Medical University, Ministry of Health of the Russian Federation
    6. Novosibirsk Regional Clinical Hospital
    7. Kuban State Medical University, Ministry of Health of the Russian Federation
    8. GBUZ Scientific and Research Institute of Regional Clinical Hospital №1 named after prof. S.V. Ochapovsky
    9. FGBOU VO North-Western State Medical University named after I.I. Mechnikov
    10. City Multidisciplinary Hospital No. 2
  • Шығарылым: № 4 (2025)
  • Беттер: 32-42
  • Бөлім: Original Articles
  • ##submission.datePublished##: 16.09.2025
  • URL: https://journals.eco-vector.com/1728-2985/article/view/690459
  • DOI: https://doi.org/10.18565/urology.2025.4.32-42
  • ID: 690459

Дәйексөз келтіру

Толық мәтін

Ашық рұқсат Ашық рұқсат
Рұқсат жабық Рұқсат берілді
Рұқсат жабық Рұқсат ақылы немесе тек жазылушылар үшін

Аннотация

Aim. To evaluate the efficiency, safety, and tolerability of Urorek® (silodosin, 8 mg) in empirical therapy of lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) without prior diagnostic assessment.

Materials and Methods. An open, prospective, multicenter observational study (MERCURY) was carried out in five clinical centers in Russia with the participation of 123 men (114 completed per protocol), aged 50–83 years. Urorek was prescribed empirically to patients with moderate LUTS. Efficacy was assessed using IPSS, QoL, VPSS scores, uroflowmetry parameters (Qmax, Qave), International Index of Erectile Function (IIEF), and hemodynamic parameters. The treatment duration was 90 days.

Results. At day 15, a significant IPSS decrease of 3.77 points was observed; at 1 and 3 months the reduction was 5.63 and 6.86 points, respectively (p < 0.001). QoL, VPSS, Qmax, and Qave improved significantly at all stages. By day 15, Qmax increased by 2.49 ml/s, and by day 91 by 4.74 ml/s (35.5% increase). Adverse events occurred in 1.72% (retrograde ejaculation); no cases of orthostatic hypotension or arrhythmia were recorded. The drug had no significant effect on blood pressure or heart rate.

Discussion. Silodosin demonstrated a rapid and marked effect on both voiding and storage symptoms of BPH, improving quality of life. Efficiency was evident as early as 15 days. VPSS showed strong correlation with IPSS and can be used in elderly or cognitively impaired patients. The drug demonstrated a high safety profile, especially in comorbid patients, and can be prescribed under conditions of limited diagnostic resources.

Conclusion. Urorek® (silodosin, 8 mg) is effective and safe for empirical treatment of LUTS in BPH patients, including elderly and comorbid individuals. Its high selectivity for α1A-adrenergic receptors, low risk of drug-drug interactions, and lack of cardiovascular effects make it a treatment of choice for patients with LUTS/BPH prior to completion of the full diagnostic work-up.

Толық мәтін

Рұқсат жабық

Авторлар туралы

Dmitry Pushkar

FGBOU VO «Russian University of Medicine», Ministry of Health of the Russian Federation; S.P. Botkin Moscow Multidisciplinary Clinical and Research Center

Email: pushkardm@mail.ru
ORCID iD: 0000-0002-6096-5723

Academician of RAS, Ph.D., MD, Professor, Chief Urologist of the Ministry of Health of Russia, Chief Urologist of the Moscow Health Department, Head of the Department of Urology; Chief of Moscow Urological Center

Ресей, 127006, Moscow, Dolgorukovskaya str., 4; 125284, Moscow, 2nd Botkinsky proezd, 5

Alexander Bernikov

FGBOU VO «Russian University of Medicine», Ministry of Health of the Russian Federation; S.P. Botkin Moscow Multidisciplinary Clinical and Research Center

Хат алмасуға жауапты Автор.
Email: bernikov@mac.com
ORCID iD: 0000-0001-8361-585X

Ph.D., Associate Professor at the Department of Urology; Urologist, Oncologist of Moscow Urological Center

Ресей, 127006, Moscow, Dolgorukovskaya str., 4; 125284, Moscow, 2nd Botkinsky proezd, 5

Andrey Shvedov

S.P. Botkin Moscow Multidisciplinary Clinical and Research Center

Email: dr.shvedov135@mail.ru
ORCID iD: 0000-0003-3127-9270

Urologist at Urology Department No. 41 of Moscow Urological Center

Ресей, 125284, Moscow, 2nd Botkinsky proezd, 5

Alexander Zyryanov

Ural State Medical University, Ministry of Health of the Russian Federation; Sverdlovsk Regional Clinical Hospital No. 1

Email: zav1965@mail.ru
ORCID iD: 0000-0001-8105-7233

Ph.D., MD, Professor, Head of the Department of Urology, Nephrology and Transplantology; Head of the Regional Urology Center

Ресей, 620028, Yekaterinburg, Repin str., 3; 620102, Yekaterinburg, Volgogradskaya str., 185

Igor Feofilov

Novosibirsk State Medical University, Ministry of Health of the Russian Federation

Email: fil_urolog@mail.ru
ORCID iD: 0000-0001-8938-2479

Ph.D., MD, Associate Professor, Chief Urologist of the Ministry of Health of Novosibirsk Region, Chairman of the Novosibirsk Branch of the Russian Urological Society, Honored Doctor of the Russian Federation, Head of the Department of Urology

Ресей, 630091, Novosibirsk, Krasny Prospect, 52

Andrey Igoshkin

Novosibirsk State Medical University, Ministry of Health of the Russian Federation; Novosibirsk Regional Clinical Hospital

Email: dr.igoshkin@mail.ru
ORCID iD: 0009-0002-3665-1027

Urologist; Assistant at the Department of Urology

Ресей, 630091, Novosibirsk, Krasny Prospect, 52; 630087, Novosibirsk, Nemirovich-Danchenko str., 130

Vladimir Medvedev

Kuban State Medical University, Ministry of Health of the Russian Federation; GBUZ Scientific and Research Institute of Regional Clinical Hospital №1 named after prof. S.V. Ochapovsky

Email: medvedev_vl@mail.ru
ORCID iD: 0000-0001-8335-2578

Ph.D., MD, Professor, Head of the Urology Department; Deputy Chief Physician for Urology

Ресей, 350063, Krasnodar, Mitrofana Sedina str., 4; 350086, Krasnodar, May 1 str., 167

Mikhail Efremov

Kuban State Medical University, Ministry of Health of the Russian Federation; GBUZ Scientific and Research Institute of Regional Clinical Hospital №1 named after prof. S.V. Ochapovsky

Email: efremov.uro@yandex.ru
ORCID iD: 0000-0003-2733-0619

Ph.D., Assistant at the Department of Urology; Urologist

Ресей, 350063, Krasnodar, Mitrofana Sedina str., 4; 350086, Krasnodar, May 1 str., 167

Boris Komyakov

FGBOU VO North-Western State Medical University named after I.I. Mechnikov; City Multidisciplinary Hospital No. 2

Email: komyakovbk@mail.ru
ORCID iD: 0000-0002-8606-9791

Ph.D., MD, Professor, Head of the Department of Urology; Head of
the Department and Director of the Scientific and Practical Urology
Center

Ресей, 191015, St. Petersburg, Kirochnaya str., 41; 194354, Saint Petersburg, Uchebny Lane, 5

Vladimir Fadeev

FGBOU VO North-Western State Medical University named after I.I. Mechnikov

Email: fad_ur_75@mail.ru
ORCID iD: 0009-0005-0509-037X

Professor at the Department of Urology

Ресей, 191015, St. Petersburg, Kirochnaya str., 41

Әдебиет тізімі

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  13. Osman N.I., Chapple C.R., Tammela T.L., Eisenhardt A., Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015;33(5):697–706.
  14. https://go.drugbank.com/drug-interaction-checker дата обращения 18.06.2025
  15. General characteristics of the drug Urorek dated 07.08.2023. Available at: http://eec.eaeunion.org/. Russian (Общая характеристика лекарственного препарата Урорек от 07.08.2023, http://eec.eaeunion.org/)
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  17. Marks L.S., Gittelman M.C., Hill L.A., Volinn W., Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181(6):2634–40.
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Әрекет
1. JATS XML
2. Fig. 1. Research design

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3. Fig. 2. Visual Prostate Symptom Score (VPSS)

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4. Fig. 3. Dynamics of the total IPSS score

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5. Fig. 4. Dynamics of quality of life score on the QoL scale

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6. Fig. 5. Qmax dynamics

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7. Fig. 6. Dynamics of average urinary flow rate (Qave)

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8. Fig. 7. Dynamics of the score on the visual scale (VPSS)

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9. Fig. 8. Dynamics of cardiovascular system indicators. A – systolic blood pressure (SBP) indicators, B – diastolic blood pressure (DBP) indicators, C – heart rate (HR) indicators

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