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 > or = 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 > or = 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.
TY - JOUR
T1 - 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.
A1 - Roehrborn,Claus G,
PY - 2006/3/16/pubmed
PY - 2006/4/25/medline
PY - 2006/3/16/entrez
SP - 734
EP - 41
JF - BJU international
JO - BJU Int
VL - 97
IS - 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 > or = 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 > or = 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.
SN - 1464-4096
UR - https://www.unboundmedicine.com/medline/citation/16536764/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_
DB - PRIME
DP - Unbound Medicine
ER -
