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
- Authors: 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
-
Affiliations:
- Russian University of Medicine
- Botkin Moscow Multidisciplinary Clinical and Research Center
- Ural State Medical University
- Sverdlovsk Regional Clinical Hospital No. 1
- Novosibirsk State Medical University
- Novosibirsk Regional Clinical Hospital
- Kuban State Medical University
- Professor Ochapovsky Regional Clinical Hospital No. 1
- Mechnikov North-Western State Medical University
- City Multidisciplinary Hospital No. 2
- Issue: No 4 (2025)
- Pages: 32-42
- Section: ORIGINAL ARTICLES
- URL: https://journals.rcsi.science/1728-2985/article/view/316544
- DOI: https://doi.org/10.18565/urology.2025.4.32-42
- ID: 316544
Cite item
Abstract
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.
Full Text
##article.viewOnOriginalSite##About the authors
Dmitry Yu. Pushkar
Russian University of Medicine; Botkin Moscow Multidisciplinary Clinical and Research Center
Email: pushkardm@mail.ru
ORCID iD: 0000-0002-6096-5723
Dr. Sc. (Med.), Professor, Academician of the Russian Academy of Sciences, Head of the Urology Department; Chief of the Moscow Urological Center, Chief Urologist of the Ministry of Health of Russia, Chief Urologist of the Moscow Health Department
Russian Federation, 4, Dolgorukovskaya St., Moscow, 127006; 5, 2nd Botkinsky Dr., Moscow, 125284Alexander N. Bernikov
Russian University of Medicine; Botkin Moscow Multidisciplinary Clinical and Research Center
Email: bernikov@mac.com
ORCID iD: 0000-0001-8361-585X
Cand. Sc. (Med.), Associate Professor at the Urology Department; Urologist, Oncologist at the Moscow Urological Center
Russian Federation, 4, Dolgorukovskaya St., Moscow, 127006; 5, 2nd Botkinsky Dr., Moscow, 125284Andrey M. Shvedov
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 the Moscow Urological Center
Russian Federation, 5, 2nd Botkinsky Dr., Moscow, 125284Alexander V. Zyryanov
Ural State Medical University; Sverdlovsk Regional Clinical Hospital No. 1
Email: zav1965@mail.ru
ORCID iD: 0000-0001-8105-7233
Dr. Sc. (Med.), Professor, Head of the Urology, Nephrology and Transplantology Department; Head of the Regional Urology Center
Russian Federation, 3, Repin St., Yekaterinburg, 620028; 185, Volgogradskaya St., Yekaterinburg, 620102Igor V. Feofilov
Novosibirsk State Medical University
Email: fil_urolog@mail.ru
ORCID iD: 0000-0001-8938-2479
Dr. Sc. (Med.), Associate Professor, Head of the Urology Department, 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
Russian Federation, 52, Krasny Ave., Novosibirsk, 630091Andrey V. Igoshkin
Novosibirsk State Medical University; Novosibirsk Regional Clinical Hospital
Email: dr.igoshkin@mail.ru
ORCID iD: 0009-0002-3665-1027
Urologist; Assistant at the Urology Department
Russian Federation, 52, Krasny Ave., Novosibirsk, 630091; 130, Nemirovich-Danchenko St., Novosibirsk, 630087Vladimir L. Medvedev
Kuban State Medical University; Professor Ochapovsky Regional Clinical Hospital No. 1
Email: medvedev_vl@mail.ru
ORCID iD: 0000-0001-8335-2578
Dr. Sc. (Med.), Professor, Head of the Urology Department; Deputy Chief Physician for Urology
Russian Federation, 4, Sedin St., Krasnodar, 350063; 167, May 1 St., Krasnodar, 350086Mikhail E. Efremov
Kuban State Medical University; Professor Ochapovsky Regional Clinical Hospital No. 1
Email: efremov.uro@yandex.ru
ORCID iD: 0000-0003-2733-0619
Cand. Sc. (Med.), Assistant at the Department of Urology; Urologist
Russian Federation, 4, Sedin St., Krasnodar, 350063; 167, May 1 St., Krasnodar, 350086Boris K. Komyakov
Mechnikov North-Western State Medical University; City Multidisciplinary Hospital No. 2
Author for correspondence.
Email: komyakovbk@mail.ru
ORCID iD: 0000-0002-8606-9791
Dr. Sc. (Med.), Professor, Head of the Department of Urology; Head of the Department and Director of the Scientific and Practical Urology Center
Russian Federation, 41, Kirochnaya St., Saint Petersburg, 191015; 5, Uchebny Lane, Saint Petersburg, 194354Vladimir A. Fadeev
Mechnikov North-Western State Medical University
Email: fad_ur_75@mail.ru
ORCID iD: 0009-0005-0509-037X
Professor at the Department of Urology
Russian Federation, 41, Kirochnaya St., Saint Petersburg, 191015References
- Clinical guidelines of the Ministry of Health of the Russian Federation «Benign Prostatic Hyperplasia». Approved in 2024. Russian (Клинические рекомендации МЗ РФ «Доброкачественная гиперплазия предстательной железы». Год утверждения 2024).
- Djavan B. et al. State of the art on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Urology. 2004;64: 1081.
- Nasu K., Moriyama N., Kawabe K. et al. Quantification and distribution of alpha 1-adrenoceptor subtype mRNAs in human prostate: comparison of benign hypertrophied tissue and non-hypertrophied tissue. Br J Pharmacol. 1996;119(5):797–803.
- Tatemichi S., Kobayashi K., Maezawa A. A1-adrenoceptor subtype selectivity and organ specifi city of silodosin (KMD-3213). Yakugaku Zasshi. 2006;126:209–216.
- EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS) 2025.
- Choi W.S., Cho M.C., Lee J.W. et al. Efficacy and safety of silodosin in the treatment of lower urinary tract symptoms in elderly men taking antihypertensive medications. Prostate Int. 2017;5(3):113–118.
- Morganroth J. Effects of the Selective α1A-Adrenoceptor Antagonist Silodosin on ECGs of Healthy Men in a Randomized, Double-Blind, Placeboand Moxifloxacin-Controlled Study Clin Pharmacol & Therapeutics. 2010;87(5):609–613.
- Chapple C.R., Montorsi F., Tammela T.L. et al. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011;59(3):342–352.
- Montorsi F. Profile of silodosin. Eur Urol Suppl 2010;9(4):491–495.
- Cui Y., Zong H., Zhang Y. The efficacy and safety of silodosin in treating BPH: a systematic review and meta-analysis. Int Urol Nephrol. 2012;44(6):1601–09.
- Novara G. et al. Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): subgroup analyses of efficacy and safety data. Br J Urol Int. 2015;115(5);802–814.
- Yuan C., Jian Z., Ma Y. et al. Systematic review and meta-analysis of efficacy and safety of silodosin in treatment of benign prostatic hyperplasia patients with lower urinary tract symptoms. Research Square; 2020. doi: 10.21203/rs.2.23577/v1.
- 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.
- https://go.drugbank.com/drug-interaction-checker дата обращения 18.06.2025
- 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/)
- Zimichev A.A., Gusev D.O., Lukyanova D.Yu. Evaluation of the effectiveness of silodosin 8 mg in the treatment of comorbid patients with LUTS/BPH. Urologiia. 2022;6:36–40. Russian (Зимичев А.А., Гусев Д.О., Лукьянова Д.Ю. Оценка эффективности применения препарата силодозин 8 мг в терапии коморбидных пациентов c СНМП/ДГПЖ. Урология. 2022;6:36–40).
- 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.
- Montorsi F., Gandaglia G., Chapple C., Cruz F., Desgrandchamps F., Llorente C. Effectiveness and safety of silodosin in the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia: A European phase IV clinical study (SiRE study). Int J Urol. 2016;23(7):572–79.
Supplementary files
