1. 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
-
Antonio Alcaraz, Alfredo Rodríguez-Antolín, Joaquín Carballido-Rodríguez, David Castro-Díaz, Manuel Esteban-Fuertes, José Cózar-Olmo, Vincenzo Ficarra, Rafael Medina-López, Jesús Fernández-Gómez, Javier Angulo, José Medina-Polo, Francisco Brenes-Bermúdez, José Molero-García, Antonio Fernández-Pro-Ledesma, José Manasanch, on behalf of The QUALIPROST Study Group, and Pierre Fabre
- Subjects
Subset Analysis ,Tamsulosin ,Quality of life ,medicine.medical_specialty ,Combination therapy ,030232 urology & nephrology ,Urology ,lcsh:Medicine ,Therapeutics ,Article ,03 medical and health sciences ,0302 clinical medicine ,hexanic extract of Serenoa repens ,Lower urinary tract symptoms ,Aparell urinari ,medicine ,tolerability ,Adverse effect ,Storage symptoms ,BII ,BII, BPH, combination treatment, hexanic extract of Serenoa repens, moderate-severe LUTS, quality of life, storage symptoms, tamsulosin, tolerability ,Moderate-severe LUTS ,Intention-to-treat analysis ,Hiperplàsia suprarenal congènita ,business.industry ,lcsh:R ,Congenital adrenal hyperplasia ,General Medicine ,medicine.disease ,Tolerability ,Terapèutica ,Urinary organs ,quality of life ,moderate-severe LUTS ,030220 oncology & carcinogenesis ,Combination treatment ,BPH ,tamsulosin ,combination treatment ,International Prostate Symptom Score ,storage symptoms ,Hexanic extract of Serenoa repens ,business ,medicine.drug - 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.
- Published
- 2020