Presentation Authors: ANDREY VINAROV*, Dmitriy Pushkar, Leonid Spivak, Moscow, Russian Federation
Introduction: Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) are a prevalent and progressive condition in aging men. To investigate the efficacy and safety of Afalaza in men with BPH at risk of progression the multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen and endothelial NO synthase Afalaza was previously proved to modulate its molecular targets.
Methods: 249 patients of 45-60 years old with BPH and moderate LUTS, total prostate volume (TPV) â‰¥ 30 cm3, maximum urine flow rate (Qmax) of 10-15 ml/s, and serum prostatic specific antigen (PSA) < 4 ng/ml were randomly assigned to receive either Afalaza (n=125) or placebo (n=124) for 12 months. Interactive voice/web response randomization system based on a random number generator was used for patients` randomization. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score [IPSS]), Qmax, TPV, PSA, BPH clinical progression, occurrence of acute urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints. The study was conducted in accordance with the all ethic principles and was approved by the National Ethics Committee.
Results: IPSS mean (Â±standard deviation) change was -3.7Â±3.0 (95% confidence interval (CI) -4.3 to -3.2) after 12 months of Afalaza (vs. -2.9Â±2.4; 95% CI -3.3 to -2.4 in placebo; p=0.02). Qmax growth was 2.5Â±4.3 ml/s (vs. 1.4Â±3.3 in placebo; p=0.049), TPV reduced by 11.8Â±16.0% (vs. 6.5Â±14.7%; p=0.01), and PSA remained unchanged. Afalaza therapy resulted in a significant decrease in the total sum of BPH progression symptoms (p=0.01). The maximum effect of Afalaza was registered after 12 months without a tendency to form a &[laquo]plateau&[raquo]. During the study, no patient experienced AUR or BPH-related surgery. The incidence of adverse events (AEs) did not differ between the groups, nor were there any serious AEs.
Conclusions: 12-month Afalaza therapy is effective and safe for patients with BPH/LUTS. The endpoints measurements revealed the significant advantage of Afalaza compared to placebo in the overall symptoms` benefit, decrease in TPV and a decline in the risk of BPH progression. To confirm and detail the findings further research will be provided.
Source of Funding: The study was funded by a grant from OOO &[laquo]NPF &[laquo]MATERIA MEDICA HOLDING&[raquo].