The results and findings of studies of preclinical and clinical efficacy and safety of the Company’s medications and their components are published in Russian and international peer-reviewed scientific journals, including those indexed by international bibliographic databases.
Abstract Introduction. Benign prostatic hyperplasia (BPH) is one of the most common diseases in men over 50 years. The prevalence of the BPH increases with age, and pathologic features of BPH are found in about 90% of men over 80 years. Aim. The aim of the study was to study the efficacy and safety of Afalaza for the treatment of lower urinary tract symptoms (LUTS) in treatment-naïve patients with BPH. Materials and methods. A multicenter study of using Afalaza for the treatment of LUTS in treatment-naïve patients with BPH was carried out in 9 urological centers in Moscow. A total of 80 treatment-naïve patients with BPH were enrolled. The improvement in the total score of IPSS, IIEF-5 and QoL after 30 weeks of therapy was evaluated as well as changes in prostate volume and maximum urinary f low rate (Qmax). Results. After 30 weeks of therapy, there was a significant decrease in the total IPSS score. A decrease in the total IPSS score by 5.5 points (+37.9%) from 14.5±4.0 at the baseline to 9.0±4.1 at the visit 9 was seen. The QoL decreased by 1.8 (-38.3%) points from 4.7±1.0 at the baseline. The Qmax also changed from 12.7±4.6 to 16.4±5.7 (+28.3%) after 30 weeks of therapy. At the visit 9, the total IIEF5 score increased by 3.4±4.4 (+19.9%) from 17.1±4.3 at the baseline. In addition, prostate volume decreased from 42.7±11.1 at baseline to 41.0±9.8 cc post-treatment (-5.15%). A reduction of post-void residual urine volume from 26.0±25.3 at baseline to 17.7±24.2 (-31.9%) post-treatment was also shown. Conclusion. The results of a multicenter study demonstrate the efficacy of Afalaza for treatment of treatment-naïve patients with LUTS/BPH. Afalaza reduces prostate volume and improves an erectile function.
Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial
Abstract Introduction. In order to investigate the efficacy and safety of Afalaza in men with benign prostatic hyperplasia (BPH) at risk of progression, this multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen (PSA) and endothelial nitric oxide synthase (eNOs), Afalaza was previously proved to modulate its molecular targets. The mechanism of action of the drug is associated with the modulating effect of the antibiodies (RA-Abs) on the molecular targets (PSA and eNOS) by way of conformational changes. Material and methods. A total of 249 patients aged 45–60 years with BPH and moderate lower urinary tract symptoms (LUTS), total prostate volume (TPV) ≥30 cm3, Qmax 10–15 ml/s, and serum PSA<4 ng/ml were randomly assigned to receive either Afalaza (n = 125) or placebo (n = 124) for 12 months. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score), Qmax, TPV, PSA, BPH clinical progression, occurrence of acure urinary retention (AUR) events or BPH-related surgery were estimated as the study endpoints. Results. IPSS mean change was -3.7 ±3.0 (95% CI -4.3 to -3.2) after 12 months of Afalaza (vs. -2.9 ±2.4; 95% CI -3.3 to -2.4 in placebo; р = 0.02). Qmax growth was 2.5 ±4.3 ml/s (vs. 1.4 ±3.3 in placebo; p = 0.049), TPV reduced by 11.8 ±16.0% (vs. 6.5 ±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 ‘plateau’. During the study, no patients experienced AUR or BPH-related surgery. Conclusions. A 12-month course of Afalaza therapy is effective and safe for patients with BPH. The results of end points measurements revealed asignificant advantage of Afalaza compared to placebo in the overall symptoms benefit and a decline in the risk of BPH progression.