Эффективность и безопасность комбинированной терапии препаратами алфузозин (Алфупрост® МР) и солифенацин (Везигамп) у больных доброкачественной гиперплазией предстательной железы и гиперактивным мочевым пузырем: первые результаты наблюдательного многоцентрового исследования «АВИАТОР».

Abstract

Introduction. Combination therapy of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) with the use of α1-adrenoblockers and anticholinergic drugs has become the standard of treatment and is widely used in clinical practice. Materials and methods. An observational prospective multicenter study was conducted to evaluate the efficacy and safety of combined alfuzosin (Alfuprost ® MR) 10 mg/day and solifenacin (Vesigamp) 5 mg/day in patients with BPH and overactive bladder (OAB) with moderate and severe symptoms in real outpatient practice. The study included 208 patients with LUTS/BPH 60.7±6.4 years old with the following average indicators: international prostate symptom score (IPSS) – 20.2±4.9 points; obstructive symptoms – 10.8±4.2 and irritative symptoms – 9.4±2.1 (nocturia 2.8±1.0); quality of life (QoL) - 4.8±0.5; the prostate volume is 49.9±12.0 cm3 ; intravesical prostatic protrusion < 10 mm; overactive bladder symptom score (OABSS) – 10.5±2.4; patient perception of intensity of urgency scale (PPIUS) – 2.5±0.7; maximum flow rate (Qmax) – 11.5±2.1 ml/s; average flow rate (Qave) – 6.6±1.5 ml/s; urinary volume (Vcomp) – 204.1±51.4 ml; residual urine (Vres) – 49.7±35.3 ml. Control examinations were performed 1 and 3 months after the start of treatment. Results. The overwhelming number of patients achieved a statistically reliable and pronounced effect on most subjective and objective clinical indicators, which was registered a month after the start of combination treatment and intensified by the third month of follow-up. A significant improvement in LUTS according to IPSS was after 1 and 3 months, respectively: total score -45.5% and -72.3%; irritative symptoms -45.7% and -73.4%; obstructive -45.4% and -72.2%; nocturia -46.4% and -71.4%; QoL -50.0% and -79.1%. A statistically significant decrease in OAB symptoms according to the OABSS questionnaire was -50.5% and -80.9% after 1 and 3 months, respectively, including imperative urinary incontinence -50.0% and -83.3%. There was also a significant decrease in the severity of urgency according to the PPIUS questionnaire: by -52.0% and -88.0%. Combination therapy led to a rapid and significant improvement in the objective parameters of urination after 1 and 3 months, respectively: Qmax - by 32.2% and 52.2%; Qave - by 24.2% and 37.9%; Vcomp - by 4.6% and 6.5% (not significant). Vres decrease by -49.5% and -75.6%. It was not only the improvement in digital uroflowmetry (UFM) indicators, but also in the type of the UFM curves. If, before the start of treatment UFM curves close to normal were observed in only 5.3% of patients, then at the end of study already in 44.2%. Combination therapy demonstrated a high degree of safety, although 26.9% of patients had concomitant diseases. During 3 months of treatment, only 5 adverse events were registered in 5 (2.5%) patients: dry mouth – 4 (2.0%), retrograde ejaculation – 1 (0.5%). Nobody interrupted treatment due to adverse events. There were no episodes of acute urinary retention. The program showed high satisfaction of doctors with the clinical effectiveness of treatment (4.5±0.9 on the Likert scale), as well as satisfaction of both doctors and patients with the tolerability of therapy (4.5±0.9 and 4.5±0.9 on the Likert scale), respectively. Conclusion. This study is original, both in terms of the combination of the used drugs and in terms of its design features. This is the first study of alfuzosin and solifenacin combination treatment in patients with LUTS/BPH with OAB and urgency. Also, this is the first study in which the factor of intravesical prostatic protrusion > 10 mm was applied as a non-inclusion criterion. The therapy demonstrated: high and significant efficacy in relation to LUTS (irritative and obstructive), objective voiding parameters and impact on patient’s quality of life; high adherence to treatment, safety, tolerability and satisfaction with its results by doctors and patients. The effectiveness and safety of treatment in this study was achieved due to the combination of drugs used for the first time, careful selection of patients and exclusion of persons with severe mechanical bladder outlet obstruction from the observation group.