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Title: 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
Author: Alcaraz Asensio, Antonio
Rodríguez Antolín, Alfredo
Carballido Rodríguez, Joaquín
Castro Díaz, David
Esteban Fuertes, Manuel
Cózar Olmo, José M.
Ficarra, Vincenzo
Medina López, Rafael
Fernández Gómez, Jesús M.
Angulo, Javier C.
Medina Polo, José
Brenes Bermúdez, Francisco J.
Molero García, José M.
Fernández Pro Ledesma, Antonio
Manasanch, José
The QUALIPROST Study Group
Keywords: Aparell urinari
Hiperplàsia suprarenal congènita
Urinary organs
Congenital adrenal hyperplasia
Issue Date: 9-Sep-2020
Publisher: MDPI
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.
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It is part of: Journal of Clinical Medicine, 2020, vol. 9, num. 9, p. 2909
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ISSN: 2077-0383
Appears in Collections:Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)

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