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

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,...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical medicine 2020-09, Vol.9 (9), p.2909
Main Authors: Alcaraz, Antonio, Rodríguez-Antolín, Alfredo, Carballido-Rodríguez, Joaquín, Castro-Díaz, David, Esteban-Fuertes, Manuel, Cózar-Olmo, José, Ficarra, Vincenzo, Medina-López, Rafael, Fernández-Gómez, Jesús, Angulo, Javier, Medina-Polo, José, Brenes-Bermúdez, Francisco, Molero-García, José, Fernández-Pro-Ledesma, Antonio, Manasanch, José, on behalf of The QUALIPROST Study Group
Format: Article
Language:English
Subjects:
Clinical medicine
Drug dosages
Hyperplasia
Nocturia
Patients
Prostate
Quality of life
Questionnaires
Urogenital system
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm9092909