Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3‐year experience in real‐life practice

OBJECTIVES To assess the 3‐year efficacy and safety of the selective α1‐blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in ‘real‐life practice’. The influence of treatment response on the risk of acute urinary ret...

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Veröffentlicht in:BJU international 2008-04, Vol.101 (7), p.847-852
Hauptverfasser: Vallancien, Guy, Emberton, Mark, Alcaraz, Antonio, Matzkin, Haim, Van Moorselaar, R. Jeroen A., Hartung, Rudolf, Harving, Niels, Elhilali, Mostafa
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container_end_page 852
container_issue 7
container_start_page 847
container_title BJU international
container_volume 101
creator Vallancien, Guy
Emberton, Mark
Alcaraz, Antonio
Matzkin, Haim
Van Moorselaar, R. Jeroen A.
Hartung, Rudolf
Harving, Niels
Elhilali, Mostafa
description OBJECTIVES To assess the 3‐year efficacy and safety of the selective α1‐blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in ‘real‐life practice’. The influence of treatment response on the risk of acute urinary retention (AUR) and BPH‐related surgery was also analysed. PATIENTS AND METHODS In all, 689 European men (mean age 67.6 years) were enrolled by general practitioners in a 3‐year open‐label study with alfuzosin at 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its eighth question (bother score), and the Danish Prostatic Symptom Score for sexual function (DAN‐PSSsex). Efficacy was analysed at the endpoint in the intent‐to‐treat population. The impact of baseline variables (age, PSA level, IPSS and bother severity) and dynamic variables (IPSS worsening of ≥4 points and bother at the last available assessment under treatment) on the risk of AUR and BPH‐related surgery was evaluated. RESULTS With alfuzosin, IPSS improved by 6.4 points (−33.4%) from baseline (P 6 points in 71.3% and 47.2% of men, respectively. There were also significant (P 
doi_str_mv 10.1111/j.1464-410X.2008.07458.x
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Jeroen A. ; Hartung, Rudolf ; Harving, Niels ; Elhilali, Mostafa</creator><creatorcontrib>Vallancien, Guy ; Emberton, Mark ; Alcaraz, Antonio ; Matzkin, Haim ; Van Moorselaar, R. Jeroen A. ; Hartung, Rudolf ; Harving, Niels ; Elhilali, Mostafa ; ALF-ONE Study Group ; ALF‐ONE Study Group</creatorcontrib><description>OBJECTIVES To assess the 3‐year efficacy and safety of the selective α1‐blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in ‘real‐life practice’. The influence of treatment response on the risk of acute urinary retention (AUR) and BPH‐related surgery was also analysed. PATIENTS AND METHODS In all, 689 European men (mean age 67.6 years) were enrolled by general practitioners in a 3‐year open‐label study with alfuzosin at 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its eighth question (bother score), and the Danish Prostatic Symptom Score for sexual function (DAN‐PSSsex). Efficacy was analysed at the endpoint in the intent‐to‐treat population. The impact of baseline variables (age, PSA level, IPSS and bother severity) and dynamic variables (IPSS worsening of ≥4 points and bother at the last available assessment under treatment) on the risk of AUR and BPH‐related surgery was evaluated. RESULTS With alfuzosin, IPSS improved by 6.4 points (−33.4%) from baseline (P &lt; 0.001), reaching ≥3 points and &gt;6 points in 71.3% and 47.2% of men, respectively. There were also significant (P &lt; 0.001) improvements from baseline in nocturia (−0.8, −25.5%), bother score (−1.7, −40.7%) and DAN‐PSSsex weighted scores with treatment. Symptom relief was rapid and maintained over 3 years. Overall, 78 men (12.4%) had an IPSS worsening of ≥4 points, 16 (2.6%) had AUR, and 36 (5.7%) required BPH‐related surgery. Symptom deterioration during treatment and high baseline PSA values were the best predictors of AUR and BPH‐related surgery. Alfuzosin was well tolerated, dizziness being the most frequent adverse event (4.5%) possibly related to vasodilatation. Ejaculatory disorders were uncommon (0.4%). Changes in blood pressure remained marginal, including in men aged ≥65 years and those receiving antihypertensive agents. CONCLUSION Alfuzosin administered for 3 years at 10 mg once daily in real‐life practice is effective and well tolerated. High PSA values and symptom worsening under treatment appear the best predictors of AUR and BPH‐related surgery in the long term. Treatment with alfuzosin might thus help to identify patients at risk of LUTS/BPH progression in order to optimize their management.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/j.1464-410X.2008.07458.x</identifier><identifier>PMID: 18321317</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>acute urinary retention ; Adrenergic alpha-Antagonists - administration &amp; dosage ; Aged ; alfuzosin ; Biological and medical sciences ; BPH ; Disease Progression ; Erectile Dysfunction - drug therapy ; Gynecology. Andrology. Obstetrics ; Humans ; LUTS ; Male ; Male genital diseases ; Medical sciences ; Nephrology. Urinary tract diseases ; Nocturia - drug therapy ; Patient Satisfaction ; Prostatic Hyperplasia - drug therapy ; Prostatic Hyperplasia - surgery ; Prostatism - drug therapy ; Quality of Life ; Quinazolines - administration &amp; dosage ; Sexual Dysfunction, Physiological - drug therapy ; Treatment Outcome ; Tumors ; Tumors of the urinary system ; Urinary Retention - drug therapy ; Urinary tract. Prostate gland ; α1‐blockers</subject><ispartof>BJU international, 2008-04, Vol.101 (7), p.847-852</ispartof><rights>2008 THE AUTHORS</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4638-93de06e97cca1b4c1d73b9a7712c950c231a0ed7ca2c961833c338570647a2933</citedby><cites>FETCH-LOGICAL-c4638-93de06e97cca1b4c1d73b9a7712c950c231a0ed7ca2c961833c338570647a2933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1464-410X.2008.07458.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1464-410X.2008.07458.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=20217054$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18321317$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vallancien, Guy</creatorcontrib><creatorcontrib>Emberton, Mark</creatorcontrib><creatorcontrib>Alcaraz, Antonio</creatorcontrib><creatorcontrib>Matzkin, Haim</creatorcontrib><creatorcontrib>Van Moorselaar, R. Jeroen A.</creatorcontrib><creatorcontrib>Hartung, Rudolf</creatorcontrib><creatorcontrib>Harving, Niels</creatorcontrib><creatorcontrib>Elhilali, Mostafa</creatorcontrib><creatorcontrib>ALF-ONE Study Group</creatorcontrib><creatorcontrib>ALF‐ONE Study Group</creatorcontrib><title>Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3‐year experience in real‐life practice</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>OBJECTIVES To assess the 3‐year efficacy and safety of the selective α1‐blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in ‘real‐life practice’. The influence of treatment response on the risk of acute urinary retention (AUR) and BPH‐related surgery was also analysed. PATIENTS AND METHODS In all, 689 European men (mean age 67.6 years) were enrolled by general practitioners in a 3‐year open‐label study with alfuzosin at 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its eighth question (bother score), and the Danish Prostatic Symptom Score for sexual function (DAN‐PSSsex). Efficacy was analysed at the endpoint in the intent‐to‐treat population. The impact of baseline variables (age, PSA level, IPSS and bother severity) and dynamic variables (IPSS worsening of ≥4 points and bother at the last available assessment under treatment) on the risk of AUR and BPH‐related surgery was evaluated. RESULTS With alfuzosin, IPSS improved by 6.4 points (−33.4%) from baseline (P &lt; 0.001), reaching ≥3 points and &gt;6 points in 71.3% and 47.2% of men, respectively. There were also significant (P &lt; 0.001) improvements from baseline in nocturia (−0.8, −25.5%), bother score (−1.7, −40.7%) and DAN‐PSSsex weighted scores with treatment. Symptom relief was rapid and maintained over 3 years. Overall, 78 men (12.4%) had an IPSS worsening of ≥4 points, 16 (2.6%) had AUR, and 36 (5.7%) required BPH‐related surgery. Symptom deterioration during treatment and high baseline PSA values were the best predictors of AUR and BPH‐related surgery. Alfuzosin was well tolerated, dizziness being the most frequent adverse event (4.5%) possibly related to vasodilatation. Ejaculatory disorders were uncommon (0.4%). Changes in blood pressure remained marginal, including in men aged ≥65 years and those receiving antihypertensive agents. CONCLUSION Alfuzosin administered for 3 years at 10 mg once daily in real‐life practice is effective and well tolerated. High PSA values and symptom worsening under treatment appear the best predictors of AUR and BPH‐related surgery in the long term. Treatment with alfuzosin might thus help to identify patients at risk of LUTS/BPH progression in order to optimize their management.</description><subject>acute urinary retention</subject><subject>Adrenergic alpha-Antagonists - administration &amp; dosage</subject><subject>Aged</subject><subject>alfuzosin</subject><subject>Biological and medical sciences</subject><subject>BPH</subject><subject>Disease Progression</subject><subject>Erectile Dysfunction - drug therapy</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>LUTS</subject><subject>Male</subject><subject>Male genital diseases</subject><subject>Medical sciences</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Nocturia - drug therapy</subject><subject>Patient Satisfaction</subject><subject>Prostatic Hyperplasia - drug therapy</subject><subject>Prostatic Hyperplasia - surgery</subject><subject>Prostatism - drug therapy</subject><subject>Quality of Life</subject><subject>Quinazolines - administration &amp; dosage</subject><subject>Sexual Dysfunction, Physiological - drug therapy</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><subject>Urinary Retention - drug therapy</subject><subject>Urinary tract. Prostate gland</subject><subject>α1‐blockers</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUE1v1DAQtRCIlsJfQL7AbcM4TuIEiUOpKB-qxIVK3KxZZ7J45U0WeyM2nCr1D_Ab-0uYsEu54ovHb957nnlCSAWZ4vNqnamiKhaFgq9ZDlBnYIqyzvYPxOl94-HfGprqRDxJaQ3AQFU-Fieq1rnSypyK8Tx0488h-Z7N725uNys59I5kiz5Mshui3EXCne9Xckm9X_VyG4e0Y8TJb9OW4jZg8vhaotR3N78mwihpz7in2YZtWR64E3xHrEXHSnoqHnUYEj073mfi-vLdl4sPi6vP7z9enF8tXFHpetHolqCixjiHalk41Rq9bNAYlbumBJdrhUCtccjvipfSTuu6NFAVBvNG6zPx8uDLQ38fKe3sxidHIWBPw5isAW2gUQ0T6wPR8XYpUme30W8wTlaBnSO3azunaedk7Ry5_RO53bP0-fGPcbmh9p_wmDETXhwJmByGLmLvfLrn5ZArA2XBvDcH3g8faPrvAezbT9dzpX8Dl2-f1w</recordid><startdate>200804</startdate><enddate>200804</enddate><creator>Vallancien, Guy</creator><creator>Emberton, Mark</creator><creator>Alcaraz, Antonio</creator><creator>Matzkin, Haim</creator><creator>Van Moorselaar, R. Jeroen A.</creator><creator>Hartung, Rudolf</creator><creator>Harving, Niels</creator><creator>Elhilali, Mostafa</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200804</creationdate><title>Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3‐year experience in real‐life practice</title><author>Vallancien, Guy ; Emberton, Mark ; Alcaraz, Antonio ; Matzkin, Haim ; Van Moorselaar, R. Jeroen A. ; Hartung, Rudolf ; Harving, Niels ; Elhilali, Mostafa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4638-93de06e97cca1b4c1d73b9a7712c950c231a0ed7ca2c961833c338570647a2933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>acute urinary retention</topic><topic>Adrenergic alpha-Antagonists - administration &amp; dosage</topic><topic>Aged</topic><topic>alfuzosin</topic><topic>Biological and medical sciences</topic><topic>BPH</topic><topic>Disease Progression</topic><topic>Erectile Dysfunction - drug therapy</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>LUTS</topic><topic>Male</topic><topic>Male genital diseases</topic><topic>Medical sciences</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Nocturia - drug therapy</topic><topic>Patient Satisfaction</topic><topic>Prostatic Hyperplasia - drug therapy</topic><topic>Prostatic Hyperplasia - surgery</topic><topic>Prostatism - drug therapy</topic><topic>Quality of Life</topic><topic>Quinazolines - administration &amp; dosage</topic><topic>Sexual Dysfunction, Physiological - drug therapy</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><topic>Urinary Retention - drug therapy</topic><topic>Urinary tract. Prostate gland</topic><topic>α1‐blockers</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vallancien, Guy</creatorcontrib><creatorcontrib>Emberton, Mark</creatorcontrib><creatorcontrib>Alcaraz, Antonio</creatorcontrib><creatorcontrib>Matzkin, Haim</creatorcontrib><creatorcontrib>Van Moorselaar, R. Jeroen A.</creatorcontrib><creatorcontrib>Hartung, Rudolf</creatorcontrib><creatorcontrib>Harving, Niels</creatorcontrib><creatorcontrib>Elhilali, Mostafa</creatorcontrib><creatorcontrib>ALF-ONE Study Group</creatorcontrib><creatorcontrib>ALF‐ONE Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vallancien, Guy</au><au>Emberton, Mark</au><au>Alcaraz, Antonio</au><au>Matzkin, Haim</au><au>Van Moorselaar, R. Jeroen A.</au><au>Hartung, Rudolf</au><au>Harving, Niels</au><au>Elhilali, Mostafa</au><aucorp>ALF-ONE Study Group</aucorp><aucorp>ALF‐ONE Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3‐year experience in real‐life practice</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2008-04</date><risdate>2008</risdate><volume>101</volume><issue>7</issue><spage>847</spage><epage>852</epage><pages>847-852</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>OBJECTIVES To assess the 3‐year efficacy and safety of the selective α1‐blocker alfuzosin at 10 mg once daily in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in ‘real‐life practice’. The influence of treatment response on the risk of acute urinary retention (AUR) and BPH‐related surgery was also analysed. PATIENTS AND METHODS In all, 689 European men (mean age 67.6 years) were enrolled by general practitioners in a 3‐year open‐label study with alfuzosin at 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its eighth question (bother score), and the Danish Prostatic Symptom Score for sexual function (DAN‐PSSsex). Efficacy was analysed at the endpoint in the intent‐to‐treat population. The impact of baseline variables (age, PSA level, IPSS and bother severity) and dynamic variables (IPSS worsening of ≥4 points and bother at the last available assessment under treatment) on the risk of AUR and BPH‐related surgery was evaluated. RESULTS With alfuzosin, IPSS improved by 6.4 points (−33.4%) from baseline (P &lt; 0.001), reaching ≥3 points and &gt;6 points in 71.3% and 47.2% of men, respectively. There were also significant (P &lt; 0.001) improvements from baseline in nocturia (−0.8, −25.5%), bother score (−1.7, −40.7%) and DAN‐PSSsex weighted scores with treatment. Symptom relief was rapid and maintained over 3 years. Overall, 78 men (12.4%) had an IPSS worsening of ≥4 points, 16 (2.6%) had AUR, and 36 (5.7%) required BPH‐related surgery. Symptom deterioration during treatment and high baseline PSA values were the best predictors of AUR and BPH‐related surgery. Alfuzosin was well tolerated, dizziness being the most frequent adverse event (4.5%) possibly related to vasodilatation. Ejaculatory disorders were uncommon (0.4%). Changes in blood pressure remained marginal, including in men aged ≥65 years and those receiving antihypertensive agents. CONCLUSION Alfuzosin administered for 3 years at 10 mg once daily in real‐life practice is effective and well tolerated. High PSA values and symptom worsening under treatment appear the best predictors of AUR and BPH‐related surgery in the long term. Treatment with alfuzosin might thus help to identify patients at risk of LUTS/BPH progression in order to optimize their management.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>18321317</pmid><doi>10.1111/j.1464-410X.2008.07458.x</doi><tpages>6</tpages></addata></record>
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source MEDLINE; Wiley Online Library All Journals
subjects acute urinary retention
Adrenergic alpha-Antagonists - administration & dosage
Aged
alfuzosin
Biological and medical sciences
BPH
Disease Progression
Erectile Dysfunction - drug therapy
Gynecology. Andrology. Obstetrics
Humans
LUTS
Male
Male genital diseases
Medical sciences
Nephrology. Urinary tract diseases
Nocturia - drug therapy
Patient Satisfaction
Prostatic Hyperplasia - drug therapy
Prostatic Hyperplasia - surgery
Prostatism - drug therapy
Quality of Life
Quinazolines - administration & dosage
Sexual Dysfunction, Physiological - drug therapy
Treatment Outcome
Tumors
Tumors of the urinary system
Urinary Retention - drug therapy
Urinary tract. Prostate gland
α1‐blockers
title Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3‐year experience in real‐life practice
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