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Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, an...

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Autores principales: Alcaraz, Antonio, Castro-Díaz, David, Gacci, Mauro, Salonia, Andrea, Ficarra, Vincenzo, Carballido-Rodríguez, Joaquín, Rodríguez-Antolín, Alfredo, Medina-Polo, José, Fernández-Gómez, Jesús M., Cózar-Olmo, José M., Búcar-Terrades, Santiago, Pérez-León, Noemí, Brenes-Bermúdez, Francisco J., Molero-García, José M., Fernández-Pro-Ledesma, Antonio, Herdman, Michael, Angulo, Javier C., Manasanch, José
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267652/
https://www.ncbi.nlm.nih.gov/pubmed/35806900
http://dx.doi.org/10.3390/jcm11133615
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author Alcaraz, Antonio
Castro-Díaz, David
Gacci, Mauro
Salonia, Andrea
Ficarra, Vincenzo
Carballido-Rodríguez, Joaquín
Rodríguez-Antolín, Alfredo
Medina-Polo, José
Fernández-Gómez, Jesús M.
Cózar-Olmo, José M.
Búcar-Terrades, Santiago
Pérez-León, Noemí
Brenes-Bermúdez, Francisco J.
Molero-García, José M.
Fernández-Pro-Ledesma, Antonio
Herdman, Michael
Angulo, Javier C.
Manasanch, José
author_facet Alcaraz, Antonio
Castro-Díaz, David
Gacci, Mauro
Salonia, Andrea
Ficarra, Vincenzo
Carballido-Rodríguez, Joaquín
Rodríguez-Antolín, Alfredo
Medina-Polo, José
Fernández-Gómez, Jesús M.
Cózar-Olmo, José M.
Búcar-Terrades, Santiago
Pérez-León, Noemí
Brenes-Bermúdez, Francisco J.
Molero-García, José M.
Fernández-Pro-Ledesma, Antonio
Herdman, Michael
Angulo, Javier C.
Manasanch, José
author_sort Alcaraz, Antonio
collection PubMed
description The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.
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spelling pubmed-92676522022-07-09 Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study Alcaraz, Antonio Castro-Díaz, David Gacci, Mauro Salonia, Andrea Ficarra, Vincenzo Carballido-Rodríguez, Joaquín Rodríguez-Antolín, Alfredo Medina-Polo, José Fernández-Gómez, Jesús M. Cózar-Olmo, José M. Búcar-Terrades, Santiago Pérez-León, Noemí Brenes-Bermúdez, Francisco J. Molero-García, José M. Fernández-Pro-Ledesma, Antonio Herdman, Michael Angulo, Javier C. Manasanch, José J Clin Med Article The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability. MDPI 2022-06-22 /pmc/articles/PMC9267652/ /pubmed/35806900 http://dx.doi.org/10.3390/jcm11133615 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Alcaraz, Antonio
Castro-Díaz, David
Gacci, Mauro
Salonia, Andrea
Ficarra, Vincenzo
Carballido-Rodríguez, Joaquín
Rodríguez-Antolín, Alfredo
Medina-Polo, José
Fernández-Gómez, Jesús M.
Cózar-Olmo, José M.
Búcar-Terrades, Santiago
Pérez-León, Noemí
Brenes-Bermúdez, Francisco J.
Molero-García, José M.
Fernández-Pro-Ledesma, Antonio
Herdman, Michael
Angulo, Javier C.
Manasanch, José
Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title_full Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title_fullStr Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title_full_unstemmed Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title_short Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study
title_sort efficacy and tolerability of 6-month treatment with tamsulosin plus the hexanic extract of serenoa repens versus tamsulosin plus 5-alpha-reductase inhibitors for moderate-to-severe luts-bph patients: results of a paired matched clinical study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267652/
https://www.ncbi.nlm.nih.gov/pubmed/35806900
http://dx.doi.org/10.3390/jcm11133615
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