Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial
Identifieur interne : 002113 ( PascalFrancis/Corpus ); précédent : 002112; suivant : 002114Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial
Auteurs : Fernando Carrera ; Charmaine E. Lok ; Angel De Francisco ; Francesco Locatelli ; Johannes F. E. Mann ; Bernard Canaud ; Peter G. Kerr ; Iain C. Macdougall ; Anatole Besarab ; Giuseppe Villa ; Isabelle Kazes ; Bruno Van Vlem ; Shivinder Jolly ; Ulrich Beyer ; Frank C. DoughertySource :
- Nephrology, dialysis, transplantation : (Print) [ 0931-0509 ] ; 2010.
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Abstract
Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤ 1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P<0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.
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| NO : | PASCAL 11-0038073 INIST |
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| ET : | Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial |
| AU : | CARRERA (Fernando); LOK (Charmaine E.); DE FRANCISCO (Angel); LOCATELLI (Francesco); MANN (Johannes F. E.); CANAUD (Bernard); KERR (Peter G.); MACDOUGALL (Iain C.); BESARAB (Anatole); VILLA (Giuseppe); KAZES (Isabelle); VAN VLEM (Bruno); JOLLY (Shivinder); BEYER (Ulrich); DOUGHERTY (Frank C.) |
| AF : | Eurodial, Dialysis Unit/Leiria/Portugal (1 aut.); Toronto General Hospital/Toronto/Canada (2 aut.); Hospital Universitario Valdecilla/Santander/Espagne (3 aut.); Ospedale Alessandro Manzoni/Lecco/Italie (4 aut.); University of Erlangen Medical Center and KfH Kidney Center/Munchen/Allemagne (5 aut.); Lapeyronie University Hospital, CHU Montpellier/Montpellier/France (6 aut.); Nephrology Monash Medical Centre/Clayton/Australie (7 aut.); King's College Hospital/London/Royaume-Uni (8 aut.); Henry Ford Health System/Detroit/Etats-Unis (9 aut.); Nephrology and Dialysis Dept., S. Maugeri Foundation IRCCS/Pavia/Italie (10 aut.); Centre Hospitalier Universitaire de Reims/Reims/France (11 aut.); Renal Unit OLV/Aalst/Belgique (12 aut.); Clinical Research Solutions Inc/Kitchener/Canada (13 aut.); F. Hoffmann-La Roche/Basel/Suisse (14 aut., 15 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Nephrology, dialysis, transplantation : (Print); ISSN 0931-0509; Coden NDTREA; Royaume-Uni; Da. 2010; Vol. 25; No. 12; Pp. 4009-4017; Bibl. 25 ref. |
| LA : | Anglais |
| EA : | Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤ 1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P<0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa. |
| CC : | 002B27B03; 002B02G |
| FD : | Pathologie du rein; Insuffisance rénale; Traitement; Hémodialyse; Homme; Ethylène oxyde polymère; Epoétine alfa; Epoétine bêta; Etude comparative; Darbépoétine alfa; Erythropoïèse; Epuration extrarénale; Antianémique |
| FG : | Pathologie de l'appareil urinaire |
| ED : | Kidney disease; Renal failure; Treatment; Hemodialysis; Human; Ethylene oxide polymer; Epoetin alfa; Epoetin beta; Comparative study; Darbepoetin alfa; Erythropoiesis; Extrarenal dialysis; Antianemia agent |
| EG : | Urinary system disease |
| SD : | Riñón patología; Insuficiencia renal; Tratamiento; Hemodiálisis; Hombre; Etileno óxido polímero; Epoetina alfa; Epoetina beta; Estudio comparativo; Darbepoetina alfa; Eritropoyesis; Depuración extrarrenal; Agente antianémico |
| LO : | INIST-21215.354000195012470330 |
| ID : | 11-0038073 |
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Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Dougherty, Frank C" sort="Dougherty, Frank C" uniqKey="Dougherty F" first="Frank C." last="Dougherty">Frank C. Dougherty</name><affiliation><inist:fA14 i1="14"><s1>F. Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0038073</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 11-0038073 INIST</idno><idno type="RBID">Pascal:11-0038073</idno><idno type="wicri:Area/PascalFrancis/Corpus">002113</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial</title><author><name sortKey="Carrera, Fernando" sort="Carrera, Fernando" uniqKey="Carrera F" first="Fernando" last="Carrera">Fernando Carrera</name><affiliation><inist:fA14 i1="01"><s1>Eurodial, Dialysis Unit</s1><s2>Leiria</s2><s3>PRT</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Lok, Charmaine E" sort="Lok, Charmaine E" uniqKey="Lok C" first="Charmaine E." last="Lok">Charmaine E. Lok</name><affiliation><inist:fA14 i1="02"><s1>Toronto General Hospital</s1><s2>Toronto</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="De Francisco, Angel" sort="De Francisco, Angel" uniqKey="De Francisco A" first="Angel" last="De Francisco">Angel De Francisco</name><affiliation><inist:fA14 i1="03"><s1>Hospital Universitario Valdecilla</s1><s2>Santander</s2><s3>ESP</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation><inist:fA14 i1="04"><s1>Ospedale Alessandro Manzoni</s1><s2>Lecco</s2><s3>ITA</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Mann, Johannes F E" sort="Mann, Johannes F E" uniqKey="Mann J" first="Johannes F. E." last="Mann">Johannes F. E. Mann</name><affiliation><inist:fA14 i1="05"><s1>University of Erlangen Medical Center and KfH Kidney Center</s1><s2>Munchen</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name><affiliation><inist:fA14 i1="06"><s1>Lapeyronie University Hospital, CHU Montpellier</s1><s2>Montpellier</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kerr, Peter G" sort="Kerr, Peter G" uniqKey="Kerr P" first="Peter G." last="Kerr">Peter G. Kerr</name><affiliation><inist:fA14 i1="07"><s1>Nephrology Monash Medical Centre</s1><s2>Clayton</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C." last="Macdougall">Iain C. Macdougall</name><affiliation><inist:fA14 i1="08"><s1>King's College Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Besarab, Anatole" sort="Besarab, Anatole" uniqKey="Besarab A" first="Anatole" last="Besarab">Anatole Besarab</name><affiliation><inist:fA14 i1="09"><s1>Henry Ford Health System</s1><s2>Detroit</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name><affiliation><inist:fA14 i1="10"><s1>Nephrology and Dialysis Dept., S. Maugeri Foundation IRCCS</s1><s2>Pavia</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Kazes, Isabelle" sort="Kazes, Isabelle" uniqKey="Kazes I" first="Isabelle" last="Kazes">Isabelle Kazes</name><affiliation><inist:fA14 i1="11"><s1>Centre Hospitalier Universitaire de Reims</s1><s2>Reims</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Van Vlem, Bruno" sort="Van Vlem, Bruno" uniqKey="Van Vlem B" first="Bruno" last="Van Vlem">Bruno Van Vlem</name><affiliation><inist:fA14 i1="12"><s1>Renal Unit OLV</s1><s2>Aalst</s2><s3>BEL</s3><sZ>12 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Jolly, Shivinder" sort="Jolly, Shivinder" uniqKey="Jolly S" first="Shivinder" last="Jolly">Shivinder Jolly</name><affiliation><inist:fA14 i1="13"><s1>Clinical Research Solutions Inc</s1><s2>Kitchener</s2><s3>CAN</s3><sZ>13 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name><affiliation><inist:fA14 i1="14"><s1>F. Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Dougherty, Frank C" sort="Dougherty, Frank C" uniqKey="Dougherty F" first="Frank C." last="Dougherty">Frank C. Dougherty</name><affiliation><inist:fA14 i1="14"><s1>F. Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">Nephrology, dialysis, transplantation : (Print)</title><title level="j" type="abbreviated">Nephrol. dial. transplant. : (Print)</title><idno type="ISSN">0931-0509</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Nephrology, dialysis, transplantation : (Print)</title><title level="j" type="abbreviated">Nephrol. dial. transplant. : (Print)</title><idno type="ISSN">0931-0509</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antianemia agent</term><term>Comparative study</term><term>Darbepoetin alfa</term><term>Epoetin alfa</term><term>Epoetin beta</term><term>Erythropoiesis</term><term>Ethylene oxide polymer</term><term>Extrarenal dialysis</term><term>Hemodialysis</term><term>Human</term><term>Kidney disease</term><term>Renal failure</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Pathologie du rein</term><term>Insuffisance rénale</term><term>Traitement</term><term>Hémodialyse</term><term>Homme</term><term>Ethylène oxyde polymère</term><term>Epoétine alfa</term><term>Epoétine bêta</term><term>Etude comparative</term><term>Darbépoétine alfa</term><term>Erythropoïèse</term><term>Epuration extrarénale</term><term>Antianémique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤ 1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P<0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0931-0509</s0></fA01><fA02 i1="01"><s0>NDTREA</s0></fA02><fA03 i2="1"><s0>Nephrol. dial. transplant. : (Print)</s0></fA03><fA05><s2>25</s2></fA05><fA06><s2>12</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial</s1></fA08><fA11 i1="01" i2="1"><s1>CARRERA (Fernando)</s1></fA11><fA11 i1="02" i2="1"><s1>LOK (Charmaine E.)</s1></fA11><fA11 i1="03" i2="1"><s1>DE FRANCISCO (Angel)</s1></fA11><fA11 i1="04" i2="1"><s1>LOCATELLI (Francesco)</s1></fA11><fA11 i1="05" i2="1"><s1>MANN (Johannes F. E.)</s1></fA11><fA11 i1="06" i2="1"><s1>CANAUD (Bernard)</s1></fA11><fA11 i1="07" i2="1"><s1>KERR (Peter G.)</s1></fA11><fA11 i1="08" i2="1"><s1>MACDOUGALL (Iain C.)</s1></fA11><fA11 i1="09" i2="1"><s1>BESARAB (Anatole)</s1></fA11><fA11 i1="10" i2="1"><s1>VILLA (Giuseppe)</s1></fA11><fA11 i1="11" i2="1"><s1>KAZES (Isabelle)</s1></fA11><fA11 i1="12" i2="1"><s1>VAN VLEM (Bruno)</s1></fA11><fA11 i1="13" i2="1"><s1>JOLLY (Shivinder)</s1></fA11><fA11 i1="14" i2="1"><s1>BEYER (Ulrich)</s1></fA11><fA11 i1="15" i2="1"><s1>DOUGHERTY (Frank C.)</s1></fA11><fA14 i1="01"><s1>Eurodial, Dialysis Unit</s1><s2>Leiria</s2><s3>PRT</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Toronto General Hospital</s1><s2>Toronto</s2><s3>CAN</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Hospital Universitario Valdecilla</s1><s2>Santander</s2><s3>ESP</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Ospedale Alessandro Manzoni</s1><s2>Lecco</s2><s3>ITA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>University of Erlangen Medical Center and KfH Kidney Center</s1><s2>Munchen</s2><s3>DEU</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Lapeyronie University Hospital, CHU Montpellier</s1><s2>Montpellier</s2><s3>FRA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Nephrology Monash Medical Centre</s1><s2>Clayton</s2><s3>AUS</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>King's College Hospital</s1><s2>London</s2><s3>GBR</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Henry Ford Health System</s1><s2>Detroit</s2><s3>USA</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>Nephrology and Dialysis Dept., S. Maugeri Foundation IRCCS</s1><s2>Pavia</s2><s3>ITA</s3><sZ>10 aut.</sZ></fA14><fA14 i1="11"><s1>Centre Hospitalier Universitaire de Reims</s1><s2>Reims</s2><s3>FRA</s3><sZ>11 aut.</sZ></fA14><fA14 i1="12"><s1>Renal Unit OLV</s1><s2>Aalst</s2><s3>BEL</s3><sZ>12 aut.</sZ></fA14><fA14 i1="13"><s1>Clinical Research Solutions Inc</s1><s2>Kitchener</s2><s3>CAN</s3><sZ>13 aut.</sZ></fA14><fA14 i1="14"><s1>F. Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>PATRONUS Investigators</s1><s3>INC</s3></fA17><fA20><s1>4009-4017</s1></fA20><fA21><s1>2010</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>21215</s2><s5>354000195012470330</s5></fA43><fA44><s0>0000</s0><s1>© 2011 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>25 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>11-0038073</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Nephrology, dialysis, transplantation : (Print)</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤ 1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P<0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.</s0></fC01><fC02 i1="01" i2="X"><s0>002B27B03</s0></fC02><fC02 i1="02" i2="X"><s0>002B02G</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Pathologie du rein</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Kidney disease</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Riñón patología</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Insuffisance rénale</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Renal failure</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Insuficiencia renal</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Traitement</s0><s5>09</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Treatment</s0><s5>09</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Tratamiento</s0><s5>09</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Hémodialyse</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Hemodialysis</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Hemodiálisis</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Homme</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Human</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Hombre</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Ethylène oxyde polymère</s0><s2>NK</s2><s2>FX</s2><s5>12</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Ethylene oxide polymer</s0><s2>NK</s2><s2>FX</s2><s5>12</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Etileno óxido polímero</s0><s2>NK</s2><s2>FX</s2><s5>12</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Epoétine alfa</s0><s2>NK</s2><s2>FR</s2><s5>13</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Epoetin alfa</s0><s2>NK</s2><s2>FR</s2><s5>13</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Epoetina alfa</s0><s2>NK</s2><s2>FR</s2><s5>13</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Epoétine bêta</s0><s2>NK</s2><s2>FR</s2><s5>14</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Epoetin beta</s0><s2>NK</s2><s2>FR</s2><s5>14</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Epoetina beta</s0><s2>NK</s2><s2>FR</s2><s5>14</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Etude comparative</s0><s5>15</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Comparative study</s0><s5>15</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>15</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Darbépoétine alfa</s0><s2>FR</s2><s5>16</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Darbepoetin alfa</s0><s2>FR</s2><s5>16</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Darbepoetina alfa</s0><s2>FR</s2><s5>16</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Erythropoïèse</s0><s5>17</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Erythropoiesis</s0><s5>17</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Eritropoyesis</s0><s5>17</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Epuration extrarénale</s0><s5>18</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Extrarenal dialysis</s0><s5>18</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Depuración extrarrenal</s0><s5>18</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Antianémique</s0><s5>78</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Antianemia agent</s0><s5>78</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Agente antianémico</s0><s5>78</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'appareil urinaire</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Urinary system disease</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Aparato urinario patología</s0><s5>37</s5></fC07><fN21><s1>024</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 11-0038073 INIST</NO><ET>Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial</ET><AU>CARRERA (Fernando); LOK (Charmaine E.); DE FRANCISCO (Angel); LOCATELLI (Francesco); MANN (Johannes F. E.); CANAUD (Bernard); KERR (Peter G.); MACDOUGALL (Iain C.); BESARAB (Anatole); VILLA (Giuseppe); KAZES (Isabelle); VAN VLEM (Bruno); JOLLY (Shivinder); BEYER (Ulrich); DOUGHERTY (Frank C.)</AU><AF>Eurodial, Dialysis Unit/Leiria/Portugal (1 aut.); Toronto General Hospital/Toronto/Canada (2 aut.); Hospital Universitario Valdecilla/Santander/Espagne (3 aut.); Ospedale Alessandro Manzoni/Lecco/Italie (4 aut.); University of Erlangen Medical Center and KfH Kidney Center/Munchen/Allemagne (5 aut.); Lapeyronie University Hospital, CHU Montpellier/Montpellier/France (6 aut.); Nephrology Monash Medical Centre/Clayton/Australie (7 aut.); King's College Hospital/London/Royaume-Uni (8 aut.); Henry Ford Health System/Detroit/Etats-Unis (9 aut.); Nephrology and Dialysis Dept., S. Maugeri Foundation IRCCS/Pavia/Italie (10 aut.); Centre Hospitalier Universitaire de Reims/Reims/France (11 aut.); Renal Unit OLV/Aalst/Belgique (12 aut.); Clinical Research Solutions Inc/Kitchener/Canada (13 aut.); F. Hoffmann-La Roche/Basel/Suisse (14 aut., 15 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Nephrology, dialysis, transplantation : (Print); ISSN 0931-0509; Coden NDTREA; Royaume-Uni; Da. 2010; Vol. 25; No. 12; Pp. 4009-4017; Bibl. 25 ref.</SO><LA>Anglais</LA><EA>Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤ 1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Results. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P<0.0001). Doses increased by 6.8% with methoxy polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Conclusions. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.</EA><CC>002B27B03; 002B02G</CC><FD>Pathologie du rein; Insuffisance rénale; Traitement; Hémodialyse; Homme; Ethylène oxyde polymère; Epoétine alfa; Epoétine bêta; Etude comparative; Darbépoétine alfa; Erythropoïèse; Epuration extrarénale; Antianémique</FD><FG>Pathologie de l'appareil urinaire</FG><ED>Kidney disease; Renal failure; Treatment; Hemodialysis; Human; Ethylene oxide polymer; Epoetin alfa; Epoetin beta; Comparative study; Darbepoetin alfa; Erythropoiesis; Extrarenal dialysis; Antianemia agent</ED><EG>Urinary system disease</EG><SD>Riñón patología; Insuficiencia renal; Tratamiento; Hemodiálisis; Hombre; Etileno óxido polímero; Epoetina alfa; Epoetina beta; Estudio comparativo; Darbepoetina alfa; Eritropoyesis; Depuración extrarrenal; Agente antianémico</SD><LO>INIST-21215.354000195012470330</LO><ID>11-0038073</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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