Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: Results of a 2-year placebo-controlled study

Research output: Contribution to journalArticle

85 Citations (Scopus)

Abstract

OBJECTIVES: To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of ≥4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration). RESULTS: Over 2 years, symptom deterioration was the most common progression event (14.3%), followed by BPH-related surgery (5.8%) and AUR (2.0%). Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1% vs placebo 1.8%, P = 0.82) but tended to reduce the risk of surgery (5.1% vs 6.5%, P = 0.18); the reduction in risk (RR) and 95% confidence interval with alfuzosin was 22 (-18 to 48)%; and significantly reduced the risk of symptom deterioration (11.7% vs 16.8%; P = 0.0013); the RR was 30 (10-46)%. The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo (16.3% vs 22.1%, P < 0.001); RR 26 (9-40)%. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with alfuzosin was comparable to that with placebo. CONCLUSIONS: Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of ≥4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.

Original languageEnglish (US)
Pages (from-to)734-741
Number of pages8
JournalBJU International
Volume97
Issue number4
DOIs
StatePublished - Apr 2006

Fingerprint

Urinary Retention
Prostatic Hyperplasia
Placebos
Risk Reduction Behavior
Prostate
Lower Urinary Tract Symptoms
Quality of Life
alfuzosin
Residual Volume
Prostate-Specific Antigen
Urine
Confidence Intervals

Keywords

  • α-blocker
  • Acute urinary retention
  • BPH
  • LUTS
  • Prolonged-release alfuzosin
  • Surgery

ASJC Scopus subject areas

  • Urology

Cite this

@article{8a01bea50d8742e08b36bac2750cd93e,
title = "Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: Results of a 2-year placebo-controlled study",
abstract = "OBJECTIVES: To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of ≥4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration). RESULTS: Over 2 years, symptom deterioration was the most common progression event (14.3{\%}), followed by BPH-related surgery (5.8{\%}) and AUR (2.0{\%}). Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1{\%} vs placebo 1.8{\%}, P = 0.82) but tended to reduce the risk of surgery (5.1{\%} vs 6.5{\%}, P = 0.18); the reduction in risk (RR) and 95{\%} confidence interval with alfuzosin was 22 (-18 to 48){\%}; and significantly reduced the risk of symptom deterioration (11.7{\%} vs 16.8{\%}; P = 0.0013); the RR was 30 (10-46){\%}. The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo (16.3{\%} vs 22.1{\%}, P < 0.001); RR 26 (9-40){\%}. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with alfuzosin was comparable to that with placebo. CONCLUSIONS: Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of ≥4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.",
keywords = "α-blocker, Acute urinary retention, BPH, LUTS, Prolonged-release alfuzosin, Surgery",
author = "Claus Roehrborn",
year = "2006",
month = "4",
doi = "10.1111/j.1464-410X.2006.06110.x",
language = "English (US)",
volume = "97",
pages = "734--741",
journal = "BJU International",
issn = "1464-4096",
publisher = "Wiley-Blackwell",
number = "4",

}

TY - JOUR

T1 - Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention

T2 - Results of a 2-year placebo-controlled study

AU - Roehrborn, Claus

PY - 2006/4

Y1 - 2006/4

N2 - OBJECTIVES: To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of ≥4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration). RESULTS: Over 2 years, symptom deterioration was the most common progression event (14.3%), followed by BPH-related surgery (5.8%) and AUR (2.0%). Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1% vs placebo 1.8%, P = 0.82) but tended to reduce the risk of surgery (5.1% vs 6.5%, P = 0.18); the reduction in risk (RR) and 95% confidence interval with alfuzosin was 22 (-18 to 48)%; and significantly reduced the risk of symptom deterioration (11.7% vs 16.8%; P = 0.0013); the RR was 30 (10-46)%. The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo (16.3% vs 22.1%, P < 0.001); RR 26 (9-40)%. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with alfuzosin was comparable to that with placebo. CONCLUSIONS: Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of ≥4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.

AB - OBJECTIVES: To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of ≥4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration). RESULTS: Over 2 years, symptom deterioration was the most common progression event (14.3%), followed by BPH-related surgery (5.8%) and AUR (2.0%). Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1% vs placebo 1.8%, P = 0.82) but tended to reduce the risk of surgery (5.1% vs 6.5%, P = 0.18); the reduction in risk (RR) and 95% confidence interval with alfuzosin was 22 (-18 to 48)%; and significantly reduced the risk of symptom deterioration (11.7% vs 16.8%; P = 0.0013); the RR was 30 (10-46)%. The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo (16.3% vs 22.1%, P < 0.001); RR 26 (9-40)%. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with alfuzosin was comparable to that with placebo. CONCLUSIONS: Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of ≥4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.

KW - α-blocker

KW - Acute urinary retention

KW - BPH

KW - LUTS

KW - Prolonged-release alfuzosin

KW - Surgery

UR - http://www.scopus.com/inward/record.url?scp=33644828388&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33644828388&partnerID=8YFLogxK

U2 - 10.1111/j.1464-410X.2006.06110.x

DO - 10.1111/j.1464-410X.2006.06110.x

M3 - Article

C2 - 16536764

AN - SCOPUS:33644828388

VL - 97

SP - 734

EP - 741

JO - BJU International

JF - BJU International

SN - 1464-4096

IS - 4

ER -