SILODOSIN IN THE TREATMENT OF PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA - RESULTS OF RUSSIAN MULTICENTER OBSERVATIONAL STUDY

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.

benign prostatic hyperplasia, lower urinary tract symptoms, IPSS score, α-adrenoblockers, silodosin