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The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study

Abstract Background Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enla...

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Published in:European urology 2010-01, Vol.57 (1), p.123-131
Main Authors: Roehrborn, Claus G, Siami, Paul, Barkin, Jack, Damião, Ronaldo, Major-Walker, Kim, Nandy, Indrani, Morrill, Betsy B, Gagnier, R. Paul, Montorsi, Francesco
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cited_by cdi_FETCH-LOGICAL-c391t-6f581c0def015098d6dd450ef9efe776e08fa5b29789233f8acea726b9235e453
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container_title European urology
container_volume 57
creator Roehrborn, Claus G
Siami, Paul
Barkin, Jack
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Montorsi, Francesco
description Abstract Background Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. Objective To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participants The Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 cm3 , prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax ) >5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Measurements The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax , prostate volume, safety, and tolerability. Results and limitations Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. Conclusions The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifier NCT00090103 ( http://www.clinicaltrials.gov/ct2/show/NCT00090103 ).
doi_str_mv 10.1016/j.eururo.2009.09.035
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Paul ; Montorsi, Francesco</creator><creatorcontrib>Roehrborn, Claus G ; Siami, Paul ; Barkin, Jack ; Damião, Ronaldo ; Major-Walker, Kim ; Nandy, Indrani ; Morrill, Betsy B ; Gagnier, R. Paul ; Montorsi, Francesco ; CombAT Study Group</creatorcontrib><description>Abstract Background Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. Objective To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participants The Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 cm3 , prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax ) &gt;5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Measurements The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax , prostate volume, safety, and tolerability. Results and limitations Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. Conclusions The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifier NCT00090103 ( http://www.clinicaltrials.gov/ct2/show/NCT00090103 ).</description><identifier>ISSN: 0302-2838</identifier><identifier>EISSN: 1873-7560</identifier><identifier>DOI: 10.1016/j.eururo.2009.09.035</identifier><identifier>PMID: 19825505</identifier><identifier>CODEN: EUURAV</identifier><language>eng</language><publisher>Kidlington: Elsevier</publisher><subject>5-alpha Reductase Inhibitors ; Adrenergic alpha-Antagonists - adverse effects ; Adrenergic alpha-Antagonists - therapeutic use ; Aged ; Azasteroids - adverse effects ; Azasteroids - therapeutic use ; Biological and medical sciences ; Brazil ; Disease Progression ; Double-Blind Method ; Drug Therapy, Combination ; Dutasteride ; Enzyme Inhibitors - adverse effects ; Enzyme Inhibitors - therapeutic use ; Gynecology. Andrology. Obstetrics ; Humans ; Italy ; Kaplan-Meier Estimate ; Male ; Male genital diseases ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; North America ; Proportional Hazards Models ; Prostatic Hyperplasia - complications ; Prostatic Hyperplasia - diagnosis ; Prostatic Hyperplasia - drug therapy ; Prostatic Hyperplasia - surgery ; Risk Assessment ; Risk Factors ; Severity of Illness Index ; Sulfonamides - adverse effects ; Sulfonamides - therapeutic use ; Time Factors ; Treatment Outcome ; Tumors ; Tumors of the urinary system ; Urinary Retention - drug therapy ; Urinary Retention - etiology ; Urinary tract. Prostate gland ; Urologic Surgical Procedures, Male ; Urology</subject><ispartof>European urology, 2010-01, Vol.57 (1), p.123-131</ispartof><rights>European Association of Urology</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c391t-6f581c0def015098d6dd450ef9efe776e08fa5b29789233f8acea726b9235e453</citedby><cites>FETCH-LOGICAL-c391t-6f581c0def015098d6dd450ef9efe776e08fa5b29789233f8acea726b9235e453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=22272338$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19825505$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roehrborn, Claus G</creatorcontrib><creatorcontrib>Siami, Paul</creatorcontrib><creatorcontrib>Barkin, Jack</creatorcontrib><creatorcontrib>Damião, Ronaldo</creatorcontrib><creatorcontrib>Major-Walker, Kim</creatorcontrib><creatorcontrib>Nandy, Indrani</creatorcontrib><creatorcontrib>Morrill, Betsy B</creatorcontrib><creatorcontrib>Gagnier, R. Paul</creatorcontrib><creatorcontrib>Montorsi, Francesco</creatorcontrib><creatorcontrib>CombAT Study Group</creatorcontrib><title>The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study</title><title>European urology</title><addtitle>Eur Urol</addtitle><description>Abstract Background Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. Objective To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participants The Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 cm3 , prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax ) &gt;5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Measurements The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax , prostate volume, safety, and tolerability. Results and limitations Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. Conclusions The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifier NCT00090103 ( http://www.clinicaltrials.gov/ct2/show/NCT00090103 ).</description><subject>5-alpha Reductase Inhibitors</subject><subject>Adrenergic alpha-Antagonists - adverse effects</subject><subject>Adrenergic alpha-Antagonists - therapeutic use</subject><subject>Aged</subject><subject>Azasteroids - adverse effects</subject><subject>Azasteroids - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Brazil</subject><subject>Disease Progression</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Dutasteride</subject><subject>Enzyme Inhibitors - adverse effects</subject><subject>Enzyme Inhibitors - therapeutic use</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Italy</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Male genital diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>North America</subject><subject>Proportional Hazards Models</subject><subject>Prostatic Hyperplasia - complications</subject><subject>Prostatic Hyperplasia - diagnosis</subject><subject>Prostatic Hyperplasia - drug therapy</subject><subject>Prostatic Hyperplasia - surgery</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Severity of Illness Index</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><subject>Urinary Retention - drug therapy</subject><subject>Urinary Retention - etiology</subject><subject>Urinary tract. 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Obstetrics</topic><topic>Humans</topic><topic>Italy</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Male genital diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>North America</topic><topic>Proportional Hazards Models</topic><topic>Prostatic Hyperplasia - complications</topic><topic>Prostatic Hyperplasia - diagnosis</topic><topic>Prostatic Hyperplasia - drug therapy</topic><topic>Prostatic Hyperplasia - surgery</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Severity of Illness Index</topic><topic>Sulfonamides - adverse effects</topic><topic>Sulfonamides - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><topic>Urinary Retention - drug therapy</topic><topic>Urinary Retention - etiology</topic><topic>Urinary tract. Prostate gland</topic><topic>Urologic Surgical Procedures, Male</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roehrborn, Claus G</creatorcontrib><creatorcontrib>Siami, Paul</creatorcontrib><creatorcontrib>Barkin, Jack</creatorcontrib><creatorcontrib>Damião, Ronaldo</creatorcontrib><creatorcontrib>Major-Walker, Kim</creatorcontrib><creatorcontrib>Nandy, Indrani</creatorcontrib><creatorcontrib>Morrill, Betsy B</creatorcontrib><creatorcontrib>Gagnier, R. Paul</creatorcontrib><creatorcontrib>Montorsi, Francesco</creatorcontrib><creatorcontrib>CombAT 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>European urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roehrborn, Claus G</au><au>Siami, Paul</au><au>Barkin, Jack</au><au>Damião, Ronaldo</au><au>Major-Walker, Kim</au><au>Nandy, Indrani</au><au>Morrill, Betsy B</au><au>Gagnier, R. Paul</au><au>Montorsi, Francesco</au><aucorp>CombAT Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study</atitle><jtitle>European urology</jtitle><addtitle>Eur Urol</addtitle><date>2010-01-01</date><risdate>2010</risdate><volume>57</volume><issue>1</issue><spage>123</spage><epage>131</epage><pages>123-131</pages><issn>0302-2838</issn><eissn>1873-7560</eissn><coden>EUURAV</coden><abstract>Abstract Background Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. Objective To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participants The Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 cm3 , prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax ) &gt;5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention Oral daily tamsulosin, 0.4 mg; dutasteride, 0.5 mg; or a combination of both. Measurements The 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax , prostate volume, safety, and tolerability. Results and limitations Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. Conclusions The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifier NCT00090103 ( http://www.clinicaltrials.gov/ct2/show/NCT00090103 ).</abstract><cop>Kidlington</cop><pub>Elsevier</pub><pmid>19825505</pmid><doi>10.1016/j.eururo.2009.09.035</doi><tpages>9</tpages></addata></record>
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subjects 5-alpha Reductase Inhibitors
Adrenergic alpha-Antagonists - adverse effects
Adrenergic alpha-Antagonists - therapeutic use
Aged
Azasteroids - adverse effects
Azasteroids - therapeutic use
Biological and medical sciences
Brazil
Disease Progression
Double-Blind Method
Drug Therapy, Combination
Dutasteride
Enzyme Inhibitors - adverse effects
Enzyme Inhibitors - therapeutic use
Gynecology. Andrology. Obstetrics
Humans
Italy
Kaplan-Meier Estimate
Male
Male genital diseases
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
North America
Proportional Hazards Models
Prostatic Hyperplasia - complications
Prostatic Hyperplasia - diagnosis
Prostatic Hyperplasia - drug therapy
Prostatic Hyperplasia - surgery
Risk Assessment
Risk Factors
Severity of Illness Index
Sulfonamides - adverse effects
Sulfonamides - therapeutic use
Time Factors
Treatment Outcome
Tumors
Tumors of the urinary system
Urinary Retention - drug therapy
Urinary Retention - etiology
Urinary tract. Prostate gland
Urologic Surgical Procedures, Male
Urology
title The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study
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