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Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter?
OBJECTIVE: The uroselective α-blocker silodosin significantly improved International Prostate Symptom Score (IPSS) in two 12-week, double-blind (DB), placebo-controlled Phase III studies in men aged ≥ 50 years with symptoms of benign prostatic hyperplasia (BPH) and maintained symptom improvement dur...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3818948/ https://www.ncbi.nlm.nih.gov/pubmed/24198640 http://dx.doi.org/10.2147/OAJU.S18941 |
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author | Kaplan, Steven A Roehrborn, Claus G Hill, Lawrence A Volinn, Weining |
author_facet | Kaplan, Steven A Roehrborn, Claus G Hill, Lawrence A Volinn, Weining |
author_sort | Kaplan, Steven A |
collection | PubMed |
description | OBJECTIVE: The uroselective α-blocker silodosin significantly improved International Prostate Symptom Score (IPSS) in two 12-week, double-blind (DB), placebo-controlled Phase III studies in men aged ≥ 50 years with symptoms of benign prostatic hyperplasia (BPH) and maintained symptom improvement during a 9-month open-label (OL) extension. This post-hoc analysis evaluated the effects of estimated prostate volume (EPV) on silodosin-mediated symptom improvement. METHODS: Patients were stratified by EPV (<30 mL or ≥ 30 mL) calculated from prostate-specific antigen (PSA) concentrations using a published algorithm. Group comparisons were done by analysis of covariance with last observations carried forward. RESULTS: Of 890 patients with PSA baseline data, 192 had EPV < 30 mL and 698 had EPV ≥ 30 mL. During DB treatment, silodosin was associated with significant symptom improvement (adjusted mean difference versus placebo) in men with EPV < 30 mL (−2.0; P = 0.038) and those with EPV ≥ 30 mL (−3.0; P < 0.0001). Among patients who received silodosin during DB treatment, changes from baseline in IPSS to the end of OL extension (mean ± standard deviation) were similar for EPV < 30 mL (n = 60, −7.0 ± 6.8) and EPV ≥ 30 mL (n = 242, −8.0 ± 7.1; P = 0.416). Also, among patients who received placebo as DB treatment, symptom improvement at the end of OL extension was similar for EPV < 30 mL (n = 62, −6.2 ± 8.1) and EPV ≥ 30 mL (n = 275, −6.7 ± 6.1; P = 0.339). CONCLUSION: Silodosin effectively relieved BPH-related symptoms for up to 12 months, irrespective of prostate size, including in patients with enlarged prostates. |
format | Online Article Text |
id | pubmed-3818948 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-38189482013-11-06 Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? Kaplan, Steven A Roehrborn, Claus G Hill, Lawrence A Volinn, Weining Open Access J Urol Original Research OBJECTIVE: The uroselective α-blocker silodosin significantly improved International Prostate Symptom Score (IPSS) in two 12-week, double-blind (DB), placebo-controlled Phase III studies in men aged ≥ 50 years with symptoms of benign prostatic hyperplasia (BPH) and maintained symptom improvement during a 9-month open-label (OL) extension. This post-hoc analysis evaluated the effects of estimated prostate volume (EPV) on silodosin-mediated symptom improvement. METHODS: Patients were stratified by EPV (<30 mL or ≥ 30 mL) calculated from prostate-specific antigen (PSA) concentrations using a published algorithm. Group comparisons were done by analysis of covariance with last observations carried forward. RESULTS: Of 890 patients with PSA baseline data, 192 had EPV < 30 mL and 698 had EPV ≥ 30 mL. During DB treatment, silodosin was associated with significant symptom improvement (adjusted mean difference versus placebo) in men with EPV < 30 mL (−2.0; P = 0.038) and those with EPV ≥ 30 mL (−3.0; P < 0.0001). Among patients who received silodosin during DB treatment, changes from baseline in IPSS to the end of OL extension (mean ± standard deviation) were similar for EPV < 30 mL (n = 60, −7.0 ± 6.8) and EPV ≥ 30 mL (n = 242, −8.0 ± 7.1; P = 0.416). Also, among patients who received placebo as DB treatment, symptom improvement at the end of OL extension was similar for EPV < 30 mL (n = 62, −6.2 ± 8.1) and EPV ≥ 30 mL (n = 275, −6.7 ± 6.1; P = 0.339). CONCLUSION: Silodosin effectively relieved BPH-related symptoms for up to 12 months, irrespective of prostate size, including in patients with enlarged prostates. Dove Medical Press 2011-06-08 /pmc/articles/PMC3818948/ /pubmed/24198640 http://dx.doi.org/10.2147/OAJU.S18941 Text en © 2011 Kaplan et al, publisher and licensee Dove Medical Press Ltd This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. |
spellingShingle | Original Research Kaplan, Steven A Roehrborn, Claus G Hill, Lawrence A Volinn, Weining Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title | Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title_full | Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title_fullStr | Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title_full_unstemmed | Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title_short | Effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of BPH: does prostate size matter? |
title_sort | effect of estimated prostate volume on silodosin-mediated improvements in the signs and symptoms of bph: does prostate size matter? |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3818948/ https://www.ncbi.nlm.nih.gov/pubmed/24198640 http://dx.doi.org/10.2147/OAJU.S18941 |
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