A multicenter, randomized, parallel, controlled, prospective, open-label study of the efficiency and safety of bovhyaluronidase azoximer in combination therapy in patients with lower urinary tract symptoms due to benign prostatic hyperplasia

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Abstract

Introduction. Lower urinary tract symptoms (LUTS) occur in 90% of middle-aged, elderly and senile men and are usually associated with benign prostatic hyperplasia (BPH). The prevalence of BPH and its negative impact on all aspects of a man's life force modern scientists to search for optimal and safe treatment strategies.

Aim. To evaluate the efficiency and safety of bovhyaluronidase azoximer (Longidaza®, lyophilisate for injection and rectal suppositories 3,000 IU) in combination with the alpha-blocker tamsulosin in the treatment of patients with LUTS associated with BPH.

Materials and methods. A total of 229 patients with LUTS associated with BPH were included in the study. They were randomly divided into an experimental group (n=118) and a control group (n=111). Patients in the experimental group received the drug Longidaza® in 2 dosage forms together with tamsulosin, while in the control group, tamsulosin was administered as monotherapy. The evaluation was carried out in outpatient settings and included five timepoints. The duration of follow-up of patients throughout the study was no more than 138 days.

Results. There were no differences between patients in the experimental and control groups in terms of baseline characteristics and duration of LUTS due to BPH (1.51±1.04 vs. 1.46±0.85 years, respectively). In the experimental group, there was a significantly more pronounced decrease in the level of symptoms according to the International Prostate Symptom Score (IPSS) at 60 (±1) and 130 (±3) days from the start of therapy compared to the baseline level (p = 0.031 and 0.004, respectively). Throughout the study, total prostate volume moderately decreased in all patients. According to the analysis of covariance, a significantly more pronounced decrease in the total NIH-CPSI score was also observed in the experimental group. In addition, in the main group the quality of life increased by 85.71%, while in the control group the positive dynamics was in 71.43% of cases. During laboratory examination it was found that the total PSA level remained virtually unchanged in patients of both groups,

There were 5 adverse events (AE) in the experimental group and 14 in the control group, and none of the AE prevented the patients from continuing to participate in the study.

Conclusion. Our results indicate greater efficiency and safety of combination therapy with Longidaza® and tamsulosin in patients with LUTS due to BPH compared to monotherapy with tamsulosin.

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About the authors

P. I. Rasner

FGBOU VO “Russian University of Medicine”

Email: dr.rasner@gmail.com
ORCID iD: 0000-0001-8383-3507

Ph.D., MD, professor, Chief of the University clinic of Scientific and Educational Institute of the Clinical Medicine named after N.A. Semashko

Russian Federation, Moscow

A. S. Al-Shukri

FGBOU VO Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Author for correspondence.
Email: ad330@mail.ru
ORCID iD: 0000-0001-6543-8589

Ph.D., MD, professor, Head of the Urological Department No1 (general and emergent urology)

Russian Federation, Saint Petersburg

I. S. Shormanov

FGBOU VO Yaroslavl State Medical University

Email: i-s-shormanov@yandex.ru

Ph.D., MD, professor, Head of the Department of Urology and Nephrology

Russian Federation, Yaroslavl

O. Kh. Tazhetdinov

LLC Krasnodar Medical and Biological Center

Email: gelotazh2007@rambler.ru
ORCID iD: 0000-0001-6162-1554

Ph.D., Chief of LLC Krasnodar Medical and Biological Center, urologist and andrologist at the Center of Reproduction and Genetics of Ekaterininskaya clinics

Russian Federation, Krasnodar

A. V. Maksimova

FGBOU VO Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: maksimova_av77@mail.ru
ORCID iD: 0000-0002-5627-2596

resident at the Department of urology

Russian Federation, Saint Petersburg

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2. Fig. 1. Dynamics of change in values ​​according to the IPSS questionnaire a) dynamics of change in values ​​according to the 1PSS questionnaire (The International Prostate Symptom Score, IPSS) in the experimental and control groups b) adjusted means, 95% CI and p-values ​​for changes in the IPSS parameter relative to Visit 1 according to the results of covariance analysis (ANCOVA)

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3. Fig. 2. Assessment of quality of life using the IPSS questionnaire (section QoL/“Quality of life due to urination disorders”)

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4. Fig. 3. Data from intergroup analysis of differences in assessing prostate volume (cm3) in the main and control groups

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5. Fig. 4. Data of intergroup analysis of differences in the total score of the NIH-CPSI questionnaire in the main and control groups a) data of intergroup analysis of differences in the total score of the NIH-CPSI questionnaire in subgroups formed according to the initial level of IPSS data (8-19 points) b) data of intergroup analysis of differences in the total score of the NIH-CPSI questionnaire in subgroups formed according to the initial level of OOM (Vom) <50m data

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