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 : 000105 ( France/Analysis ); précédent : 000104; suivant : 000106Maintenance 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 [Portugal] ; Charmaine E. Lok [Canada] ; Angel De Francisco [Espagne] ; Francesco Locatelli [Italie] ; Johannes F. E. Mann [Allemagne] ; Bernard Canaud [France] ; Peter G. Kerr [Australie] ; Iain C. Macdougall [Royaume-Uni] ; Anatole Besarab [États-Unis] ; Giuseppe Villa [Italie] ; Isabelle Kazes [France] ; Bruno Van Vlem [Belgique] ; Shivinder Jolly [Canada] ; Ulrich Beyer [Suisse] ; Frank C. Dougherty [Suisse]Source :
- Nephrology Dialysis Transplantation [ 0931-0509 ] ; 2010-12.
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 2weeks for 26weeks, with dose adjustment for individual haemoglobin target (1113g/dL; maximum decrease from baseline 1g/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 10.5g/dL, with a decrease from baseline 1g/dL, in Weeks 5053; 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.
Url:
DOI: 10.1093/ndt/gfq305
Affiliations:
- Allemagne, Australie, Belgique, Canada, Espagne, France, Italie, Portugal, Royaume-Uni, Suisse, États-Unis
- Angleterre, Grand Londres
- Londres, Montpellier, Reims
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ISTEX:593A26E6832641E0621D9DD19DDD970F4B286CA2Le document en format XML
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Lok</name></author><author><name sortKey="De Francisco, Angel" sort="De Francisco, Angel" uniqKey="De Francisco A" first="Angel" last="De Francisco">Angel De Francisco</name></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name></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></author><author><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name></author><author><name sortKey="Kerr, Peter G" sort="Kerr, Peter G" uniqKey="Kerr P" first="Peter G." last="Kerr">Peter G. Kerr</name></author><author><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C." last="Macdougall">Iain C. 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Lok</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto General Hospital, Toronto</wicri:regionArea><wicri:noRegion>Toronto</wicri:noRegion></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 wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Valdecilla, Santander</wicri:regionArea><wicri:noRegion>Santander</wicri:noRegion></affiliation></author><author><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Ospedale Alessandro Manzoni, Lecco</wicri:regionArea><wicri:noRegion>Lecco</wicri:noRegion></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 wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>University of Erlangen Medical Center and KfH Kidney Center, Munchen</wicri:regionArea><wicri:noRegion>Munchen</wicri:noRegion><wicri:noRegion>Munchen</wicri:noRegion></affiliation></author><author><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Lapeyronie University Hospital, CHU Montpellier, Montpellier</wicri:regionArea><placeName><settlement type="city">Montpellier</settlement></placeName></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 wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Nephrology Monash Medical Centre, Clayton</wicri:regionArea><wicri:noRegion>Clayton</wicri:noRegion></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 wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Kings College Hospital, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Besarab, Anatole" sort="Besarab, Anatole" uniqKey="Besarab A" first="Anatole" last="Besarab">Anatole Besarab</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry Ford Health System, Detroit</wicri:regionArea><wicri:noRegion>Detroit</wicri:noRegion></affiliation></author><author><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Nephrology and Dialysis Dept., S. Maugeri Foundation IRCCS, Pavia</wicri:regionArea><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Kazes, Isabelle" sort="Kazes, Isabelle" uniqKey="Kazes I" first="Isabelle" last="Kazes">Isabelle Kazes</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Universitaire de Reims, Reims</wicri:regionArea><placeName><settlement type="city">Reims</settlement></placeName></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 wicri:level="1"><country xml:lang="fr">Belgique</country><wicri:regionArea>Renal Unit OLV, Aalst</wicri:regionArea><wicri:noRegion>Aalst</wicri:noRegion></affiliation></author><author><name sortKey="Jolly, Shivinder" sort="Jolly, Shivinder" uniqKey="Jolly S" first="Shivinder" last="Jolly">Shivinder Jolly</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Research Solutions Inc., Kitchener</wicri:regionArea><wicri:noRegion>Kitchener</wicri:noRegion></affiliation></author><author><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></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 wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Nephrology Dialysis Transplantation</title><title level="j" type="abbrev">Nephrol Dial Transplant</title><idno type="ISSN">0931-0509</idno><idno type="eISSN">1460-2385</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2010-12">2010-12</date><biblScope unit="volume">25</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="4009">4009</biblScope><biblScope unit="page" to="4017">4017</biblScope></imprint><idno type="ISSN">0931-0509</idno></series><idno type="istex">593A26E6832641E0621D9DD19DDD970F4B286CA2</idno><idno type="DOI">10.1093/ndt/gfq305</idno><idno type="ArticleID">gfq305</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0931-0509</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="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 2weeks for 26weeks, with dose adjustment for individual haemoglobin target (1113g/dL; maximum decrease from baseline 1g/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 10.5g/dL, with a decrease from baseline 1g/dL, in Weeks 5053; 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><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Portugal</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li></region><settlement><li>Londres</li><li>Montpellier</li><li>Reims</li></settlement></list><tree><country name="Portugal"><noRegion><name sortKey="Carrera, Fernando" sort="Carrera, Fernando" uniqKey="Carrera F" first="Fernando" last="Carrera">Fernando Carrera</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Lok, Charmaine E" sort="Lok, Charmaine E" uniqKey="Lok C" first="Charmaine E." last="Lok">Charmaine E. Lok</name></noRegion><name sortKey="Jolly, Shivinder" sort="Jolly, Shivinder" uniqKey="Jolly S" first="Shivinder" last="Jolly">Shivinder Jolly</name></country><country name="Espagne"><noRegion><name sortKey="De Francisco, Angel" sort="De Francisco, Angel" uniqKey="De Francisco A" first="Angel" last="De Francisco">Angel De Francisco</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Locatelli, Francesco" sort="Locatelli, Francesco" uniqKey="Locatelli F" first="Francesco" last="Locatelli">Francesco Locatelli</name></noRegion><name sortKey="Villa, Giuseppe" sort="Villa, Giuseppe" uniqKey="Villa G" first="Giuseppe" last="Villa">Giuseppe Villa</name></country><country name="Allemagne"><noRegion><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></noRegion></country><country name="France"><noRegion><name sortKey="Canaud, Bernard" sort="Canaud, Bernard" uniqKey="Canaud B" first="Bernard" last="Canaud">Bernard Canaud</name></noRegion><name sortKey="Kazes, Isabelle" sort="Kazes, Isabelle" uniqKey="Kazes I" first="Isabelle" last="Kazes">Isabelle Kazes</name></country><country name="Australie"><noRegion><name sortKey="Kerr, Peter G" sort="Kerr, Peter G" uniqKey="Kerr P" first="Peter G." last="Kerr">Peter G. Kerr</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Macdougall, Iain C" sort="Macdougall, Iain C" uniqKey="Macdougall I" first="Iain C." last="Macdougall">Iain C. Macdougall</name></region></country><country name="États-Unis"><noRegion><name sortKey="Besarab, Anatole" sort="Besarab, Anatole" uniqKey="Besarab A" first="Anatole" last="Besarab">Anatole Besarab</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Van Vlem, Bruno" sort="Van Vlem, Bruno" uniqKey="Van Vlem B" first="Bruno" last="Van Vlem">Bruno Van Vlem</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Beyer, Ulrich" sort="Beyer, Ulrich" uniqKey="Beyer U" first="Ulrich" last="Beyer">Ulrich Beyer</name></noRegion><name sortKey="Dougherty, Frank C" sort="Dougherty, Frank C" uniqKey="Dougherty F" first="Frank C." last="Dougherty">Frank C. Dougherty</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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