TY - JOUR
T1 - Clinical Efficacy of Silodosin in Patients with Severe Lower Urinary Tract Symptoms Related to Benign Prostatic Obstruction
T2 - A Pooled Analysis of Phase 3 and 4 Trials
AU - Creta, Massimiliano
AU - Cornu, Jean Nicolas
AU - Roehrborn, Claus G.
AU - Finazzi Agrò, Enrico
AU - Montorsi, Francesco
AU - Longo, Nicola
AU - Imperatore, Vittorio
AU - De Sio, Marco
AU - Arcaniolo, Davide
AU - Mirone, Vincenzo
AU - Fusco, Ferdinando
N1 - Funding Information:
Financial disclosures: Ferdinando Fusco certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Claus G. Roehrborn has received speaker honoraria from Recordati. Francesco Montorsi has received research grants from Recordati. Enrico Finazzi-Agrò has received speaker honoraria from Pierre Fabre, Recordati, Wellspect, and Coloplast. Vincenzo Mirone and Ferdinando Fusco are speakers for Recordati. Massimiliano Creta is a speaker and medical writer for Recordati. Jean-Nicolas Cornu has received consultant fees and travel grants from Allergan, Astellas, Boston Scientific, Recordati, Coloplast, Cousin Biotech, Medtronic, Mundipharma, Pierre Fabre Médicament, SAP, Stimuli, Ixaltis, and Pfizer; is an investigator for clinical trials funded by Astellas, GT Urological, Medtronic, Ipsen, Coloplast, Cousin Biotech, Recordati, and Allergan; and has received a research grant from Medtronic. The remaining authors have nothing to disclose.
Publisher Copyright:
© 2020 European Association of Urology
PY - 2021/3
Y1 - 2021/3
N2 - We performed a post hoc analysis of data from phase 3 and 4 studies to evaluate the efficacy of silodosin 8 mg in patients with severe lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO). The presence of two or more of the following criteria was adopted to define severity: total International Prostate Symptom Score (IPSS) 20–35, quality of life (QoL) score 5–6, maximum urinary flow <5 ml/s or postvoid residual volume ≥100 ml, and prostate volume ≥50 ml. Mean improvements in total (8.1 vs 4.7), storage (3.1 vs 2.0), voiding (5.0 vs 2.7), and QoL (1.3 vs 0.7) IPSS scores were significantly greater for patients receiving silodosin compared to placebo (all p < 0.0001). Mean improvements in total, storage, voiding, and QoL IPSS scores were similar for the severe and not severe LUTS cohorts. In conclusion, silodosin significantly improves symptoms and QoL in all LUTS/BPO patients, including those with severe symptoms. Patient summary: Silodosin improves symptoms and quality of life for patients with severe lower urinary tract symptoms related to benign prostatic obstruction.
AB - We performed a post hoc analysis of data from phase 3 and 4 studies to evaluate the efficacy of silodosin 8 mg in patients with severe lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO). The presence of two or more of the following criteria was adopted to define severity: total International Prostate Symptom Score (IPSS) 20–35, quality of life (QoL) score 5–6, maximum urinary flow <5 ml/s or postvoid residual volume ≥100 ml, and prostate volume ≥50 ml. Mean improvements in total (8.1 vs 4.7), storage (3.1 vs 2.0), voiding (5.0 vs 2.7), and QoL (1.3 vs 0.7) IPSS scores were significantly greater for patients receiving silodosin compared to placebo (all p < 0.0001). Mean improvements in total, storage, voiding, and QoL IPSS scores were similar for the severe and not severe LUTS cohorts. In conclusion, silodosin significantly improves symptoms and QoL in all LUTS/BPO patients, including those with severe symptoms. Patient summary: Silodosin improves symptoms and quality of life for patients with severe lower urinary tract symptoms related to benign prostatic obstruction.
KW - Benign prostatic obstruction
KW - Lower urinary tract symptoms
KW - Silodosin
UR - http://www.scopus.com/inward/record.url?scp=85103397379&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85103397379&partnerID=8YFLogxK
U2 - 10.1016/j.euf.2020.01.014
DO - 10.1016/j.euf.2020.01.014
M3 - Article
C2 - 32057739
AN - SCOPUS:85103397379
SN - 2405-4569
VL - 7
SP - 440
EP - 443
JO - European Urology Focus
JF - European Urology Focus
IS - 2
ER -