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.
Journal of clinical medicine. 2022 Jun 22*** epublish ***
Antonio Alcaraz, David Castro-Díaz, Mauro Gacci, Andrea Salonia, Vincenzo Ficarra, Joaquín Carballido-Rodríguez, Alfredo Rodríguez-Antolín, José Medina-Polo, Jesús M Fernández-Gómez, José M Cózar-Olmo, Santiago Búcar-Terrades, Noemí Pérez-León, Francisco J Brenes-Bermúdez, José M Molero-García, Antonio Fernández-Pro-Ledesma, Michael Herdman, Javier C Angulo, José Manasanch
Urology Department, Hospital Clínic, Universitat de Barcelona, IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), 08036 Barcelona, Spain., Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain., Unit of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital (AOUC), University of Florence, 50134 Florence, Italy., Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, 20132 Milan, Italy., Department of Human and Pediatric Pathology "Gaetano Barresi", Urology Section, University of Messina, 98125 Messina, Italy., Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain., Urology Department, Research Institute i + 12, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain., Urology Department, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain., Urology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain., Urology Department, Hospital El Pilar, Quirónsalud, 08006 Barcelona, Spain., Gran Sol Primary Care Center, 08914 Badalona, Spain., SEMERGEN Nefro-Urology Working Group, 08338 Premià de Dalt, Spain., San Andrés Primary Care Center, 28021 Madrid, Spain., Menasalbas Primary Care Center, 45128 Toledo, Spain., Insight Consulting and Research, 08301 Mataró, Spain., Clinical Department, Universidad Europea de Madrid, 28905 Getafe, Spain., SEMERGEN, 08329 Teià, Spain.