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

Urology Department, Research Group in Men’s Integral Health, Instituto de Investigación i+12, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain

Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain

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Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain

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Urology Department, Hospital Nacional de Parapléjicos, 45004 Toledo, Spain

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Urology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain

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Urology Department, University of Messina, 98125 Messina, Italy

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Urology Department, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain

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Urology Department, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain

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Urology Department, Hospital Universitario de Getafe, 28905 Getafe, Spain

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ABS Llefià, 08913 Badalona, Spain

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San Andrés Primary Care Center, 28021 Madrid, Spain

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Menasalbas Primary Care Center, 45128 Toledo, Spain

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Pierre Fabre Ibérica S.A., 08005 Barcelona, Spain

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Members of the study group are listed in the Appendix A.

J. Clin. Med. 2020, 9(9), 2909; https://doi.org/10.3390/jcm9092909

Received: 30 July 2020 / Revised: 31 August 2020 / Accepted: 4 September 2020 / Published: 9 September 2020

(This article belongs to the Section Nephrology & Urology)

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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 < 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. View Full-Text

Keywords: moderate-severe LUTS; BPH; BII; combination treatment; tamsulosin; hexanic extract of Serenoa repens; quality of life; storage symptoms; tolerability

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MDPI and ACS Style

Alcaraz, A.; Rodríguez-Antolín, A.; Carballido-Rodríguez, J.; Castro-Díaz, D.; Esteban-Fuertes, M.; Cózar-Olmo, J.M.; Ficarra, V.; Medina-López, R.; Fernández-Gómez, J.M.; Angulo, J.C.; Medina-Polo, J.; Brenes-Bermúdez, F.J.; Molero-García, J.M.; Fernández-Pro-Ledesma, A.; Manasanch, J.; on behalf of The QUALIPROST Study Group. 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. J. Clin. Med. 2020, 9, 2909. https://doi.org/10.3390/jcm9092909

AMA Style

Alcaraz A, Rodríguez-Antolín A, Carballido-Rodríguez J, Castro-Díaz D, Esteban-Fuertes M, Cózar-Olmo JM, Ficarra V, Medina-López R, Fernández-Gómez JM, Angulo JC, Medina-Polo J, Brenes-Bermúdez FJ, Molero-García JM, Fernández-Pro-Ledesma A, Manasanch J, on behalf of The QUALIPROST Study Group. 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. Journal of Clinical Medicine. 2020; 9(9):2909. https://doi.org/10.3390/jcm9092909

Chicago/Turabian Style

Alcaraz, Antonio, Alfredo Rodríguez-Antolín, Joaquín Carballido-Rodríguez, David Castro-Díaz, Manuel Esteban-Fuertes, José M. Cózar-Olmo, Vincenzo Ficarra, Rafael Medina-López, Jesús M. Fernández-Gómez, Javier C. Angulo, José Medina-Polo, Francisco J. Brenes-Bermúdez, José M. Molero-García, Antonio Fernández-Pro-Ledesma, José Manasanch, and on behalf of The QUALIPROST Study Group. 2020. "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" Journal of Clinical Medicine 9, no. 9: 2909. https://doi.org/10.3390/jcm9092909

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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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