Silodosin in the Treatment of Patients with Benign Prostatic Hyperplasia – Results of Russian Multicenter Observational Study


D.Yu. Pushkar, A.N. Bernikov, A.V. Sadchenko

Department of Urology of the Moscow State Medical Stomatological University n.a. A.I. Evdokimov, Moscow
The study was aimed to the evaluation of the therapeutic effect of the drug Silodosin at a dose of 8 mg once a day in patients with symptomatic benign prostatic hyperplasia (BPH). This study included 1,000 patients. The average age of the patients was 64.99±8.07 years (median 64.5 years), mean duration of BPH – 3.64±5.058 years (median 1.1 years). Such a large scatter is due to the enormous heterogeneity of the data; in such cases, it is advisable to focus on the median value. 12 (1.2%) patients discontinued study early, 4 of them due to adverse drug reactions, 1 patient withdrew informed consent, 7 patients were lost to follow up. Among comorbidities, cardiovascular diseases and cerebrovascular disease had the highest frequency – both in 39 (3.9%) patients. The frequency of other preexisting disease did not reach 3%. According to the history of cases, urinary retention occurred in 115 (11.5%) patients, urinary tract infections – in 131 (13.1%), prostatitis – in 171 (17.1%), abnormal ejaculation – 55 (5.5%), erectile dysfunction – in 103 (10.3%).
The primary efficacy variable was the change of total IPSS score. At visit 1, the average total score was 19.29±5.93, at visit 2 (4 weeks) – 13.30±5.31 (P<0.001), at visit 3 (8 weeks) – 9.80±4.95 (P<0.001), at last available to the observation visit – 9.84±4.90, and the change was statistically significant compared with baseline score (P<0.001). The study revealed the positive dynamics of lower urinary tract symptoms, as well as positive changes in the assessment of quality of life. Thus, at the time of the last available observation, the QoL score was 1.93±1.03 points against 4.25 points at visit 1 and was statistically significant (P<0.001). During the study, 12 (1.2%) patients had 13 adverse events, and doctors associated 11 of them with taking the drug (silodosin); information on relation with any drug was absent in 2 of 13 cases.

Literature


1. Пушкарь Д.Ю., Тутельян В.А., Малхасян В.А. Заболевания предстательной железы: краткий справочник. М.: ГЭОТАР-Медиа, 2014. 192 с.

2. Braun M.H., Sommer F., Haupt G., Mathers M.J., Reifenrath B., Engelmann U.H. Lower urinary tract symptoms and erectile dysfunction: co-morbidity or typical «Aging Male» symptoms? Results of the «Cologne Male Survey». Eur. Urol. 2003;44:588–594.

3. Parsons J.K., Messer K., White M., Barrett-Connor E., Bauer D.C., Marshall L.M. Obesity increases and physical activity decreases lower urinary tract symptom risk in older men: the Osteoporotic Fractures in Men study. Eur. Urol. 2011;60:1173–1180.

4. Урология. Российские клинические рекомендации / под ред. Ю.Г. Аляева, П.В. Глыбочко, Д.Ю. Пушкаря. М.:ГЭОТАР-Медиа, 2015. 480 с.

5. http://uroweb.org/fileadmin/guidelines/Guidelines_2014_5_June-2014.pdf.

6. Milani S., Djavan B. Lower urinary tract symptoms suggestive of benign prostatic hyper-plasia: latest updated on a1-adrenoceptor antagonists. BJU Int. 2005;95(Suppl. 4):29–36.

7. Яровой С.К. Силодозин – новый препарат группы селективных α1-адреноблокаторов. Экспериментальная и клиническая урология. 2012;3:67–62.

8. Nickel J.C., Sander S., Moon T.D. A-meta-analysis of the vascular-related safety profile and efficacy of a-adrenergic blockers for symptoms related to benign prostatic hyperplasia. Int J Clin Pract. 2008;62:1547–1559.

9. Morishima S., Suzuki F., Nishimune A. Visualization and tissue distribution of a1-adrenoceptor in human prostate by the fluorescently labeled ligand Alexa-488-silodosin. J. Urol. 2009;183:812–819.

10. Tatemichi S., Kobayashi K., Maezawa A. A1-adrenoceptor subtype selectivity and organ specifi city of silodosin (KMD- 3213). Yakugaku Zasshi. 2006;126:209–216.

11. online

12. European Medicines Agency. Summary of product characteristics: Urorec (silodosin) [online

13. Bosch J.L. Urodynamic effects of various treatment modalities for benign prostatic hyperplasia. J. Urol. 1997;158:2034–2044.

14. Marks L., Gittelmann M.C., Hill L.A., Volinn W., Hoel G. Rapid effi cacy of the highly selective alpha 1A-adrenoceptor antagonists silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009;181:2634–2640.


About the Autors


Corresponding author: A.N. Bernikov – PhD in Medical Sciences, Assistant Professor at the Department of Urology MSMSU; e-mail: bernikov@mac.com


Similar Articles


Бионика Медиа