Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

Antonio Alcaraz,José Cózar-Olmo,José Molero-García,Rafael Medina-López,José Manasanch,Javier Angulo,Joaquín Carballido-Rodríguez,José Medina-Polo,David Castro-Díaz,On Behalf Of The Qualiprost Study Group,Alfredo Rodríguez-Antolín,Jesús Fernández-Gómez,Antonio Fernández-Pro-Ledesma,Manuel Esteban-Fuertes,Francisco Brenes-Bermúdez,Vincenzo Ficarra

doi:10.3390/jcm9092909

Abstract

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability.

Highlights

Lower urinary tract symptoms (LUTS) are a common chronic condition in adult men and are frequently associated with benign prostatic hyperplasia (BPH), they can be caused by bladder dysfunction and other diseases affecting the urinary system [1]
The aim of this subset analysis from the QUALIPROST study was to investigate whether tamsulosin (TAM) and hexanic extract of Serenoa repens (HESr) are more effective when used in combination or alone in men with moderate to severe LUTS/BPH managed in conditions of usual clinical practice
The present analysis suggests that changes in symptoms are linked to modifications in quality of life (QoL), as the pattern of improvement on the International Prostate Symptom Score (IPSS) was similar to that seen on the Benign Prostatic Hyperplasia Impact (BII), i.e., all three arms showed improvement in QoL, but the largest mean improvement was seen in patients receiving combination therapy

Summary

Introduction

Lower urinary tract symptoms (LUTS) are a common chronic condition in adult men and are frequently associated with benign prostatic hyperplasia (BPH), they can be caused by bladder dysfunction and other diseases affecting the urinary system [1]. While previous studies have reported on the experience of using HESr in combination with alpha-blockers [22,23], with positive results for the combination treatment over alpha-blocker monotherapy, no study to date has simultaneously evaluated and compared the combined therapy and both constituent treatments separately in conditions of real-world practice The aim of this subset analysis from the QUALIPROST study was to investigate whether tamsulosin (TAM) and HESr are more effective when used in combination or alone in men with moderate to severe LUTS/BPH managed in conditions of usual clinical practice. We evaluated and compared the tolerability of the combination treatment and monotherapy

Patients and Study Design

Study Variables

Statistical Analysis

Results

Discussion

Conclusions

A Coruña