Daytime and nighttime urinary frequency is a common complaint in patients with benign prostatic hyperplasia (BPH). The most common reason for seeking elective surgery is an ineffective treatment with alpha-blockers. The aim of the study was to evaluate the efficacy and safety of combination therapy with tamsulosin 0.4 mg and mirabegron 50 mg in patients with BPH and predominant irritative symptoms.
from January 2018 to December 2019 in the outpatient department of the city clinical hospital named after D.D. Pletnev, a total of 64 patients with BPH with complains of frequent nighttime and daytime frequency and a desire to undergo surgery were followed. The patients underwent a comprehensive clinical and laboratory examination, according to which 10 patients had indications for surgery, and they were excluded from the study. In 6 patients, the prevalence of nocturnal over daytime diuresis was revealed and they were also excluded. Combination therapy with tamsulosin 0.4 mg and mirabegron 50 mg a day was prescribed to 48 patients. The average duration of therapy was 15.4 +/- 3.1 months. Patients underwent a follow-up examination to evaluate the efficiency and safety after 3, 6 and 12 months of therapy. Adverse events, possibly treatment-related, were recorded.
there was an additional decrease in irritative complaints according to the I-PSS, namely 2 points after 3 months and 4 points after 6 and 12 months. In addition, a decrease in the number of nocturnal urinations by one, a decrease in daytime urination by one after 3 months and by two after 6 and 12 months, as well as an increase in the average voided volume from 150 +/- 33 to 240 +/- 40 ml after 12 months of therapy was seen. The change in other parameters was not significant. Two patients stopped taking the drug due to non-medical reasons. In other 2 patients, the development of sinus tachycardia and a transient increase in blood pressure were noted, which did not require discontinuation of the drug.
Combination therapy with tamsulosin 0.4 mg and mirabegron 50 mg reduces the frequency of daytime and night urination with the maximum effect after 6-12 months, improves the quality of life and has a good safety profile.