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

Pushkar D.Yu., Bernikov A.N., Shvedov А.М., Zyryanov A.V., Feofilov I.V., Igoshkin A.V., Medvedev V.L., Efremov M.E., Komyakov B.K., Fadeev V.A.

1) FGBOU VO «Russian University of Medicine», Ministry of Health of the Russian Federation, Moscow, Russia; 2) S.P. Botkin Moscow Multidisciplinary Clinical and Research Center, Moscow, Russia; 3) Ural State Medical University, Ministry of Health of the Russian Federation, Yekaterinburg, Russia; 4) Regional Urology Center, Sverdlovsk Regional Clinical Hospital No. 1, Yekaterinburg, Russia; 5) Novosibirsk State Medical University, Ministry of Health of the Russian Federation, Novosibirsk, Russia; 6) Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia; 7) Kuban State Medical University, Ministry of Health of the Russian Federation, Krasnodar, Russia; 8) GBUZ Scientific and Research Institute of Regional Clinical Hospital №1 named after prof. S.V. Ochapovsky, Krasnodar, Russia; 9) FGBOU VO North-Western State Medical University named after I.I. Mechnikov, Saint Petersburg, Russia; 10) City Multidisciplinary Hospital No. 2, Saint Petersburg, Russia

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.

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About the Authors

Corresponding author: A.N. Bernikov – Ph.D., associate professor at the Department of Urology of FGBOU VO «Russian University of Medicine»; e-mail: bernikov@mac.com

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