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.
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2020-09-09
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Alcaraz, 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
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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
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BII, BPH, combination treatment, hexanic extract of Serenoa repens, moderate-severe LUTS, quality of life, storage symptoms, tamsulosin, tolerability