Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi

Translated title of the contribution: Effects of dose of erythropoiesis stimulating agents on cardiovascular outcomes, quality of life and costs of haemodialysis. the clinical evaluation of the DOSe of erythropoietins (C.E. DOSE) Trial

V. Saglimbene, D. D'Alonzo, M. Ruospo, M. Vecchio, P. Natale, L. Gargano, A. Nicolucci, F. Pellegrini, J. C. Craig, G. Triolo, D. A. Procaccini, A. Santoro, S. Di Giulio, S. La Rosa, A. Murgo, R. Di Toro Mammarella, M. Sambati, N. D'Ambrosio, V. Greco, G. Giannoccaro & 60 others A. Flammini, E. Boccia, G. Montalto, S. Pagano, S. Amarù, M. Fici, G. Barone Lumaga, E. Mancini, M. Veronesi, L. Patregnani, M. Querques, P. Schiavone, S. Chimienti, R. Palumbo, D. Di Franco, M. Della Volpe, E. Gori, M. Salomone, A. Iacono, M. Moscoloni, A. Treglia, D. Casu, A. M. Piras, A. Di Silva, M. Mandreoli, A. Lopez, F. Quarello, L. Catizone, G. Russo, S. Forcellini, M. Maccarone, G. Catucci, B. Di Paolo, A. Stingone, B. D'Angelo, C. Guastoni, S. Pasquali, C. Minoretti, A. Bellasi, G. Boscutti, M. Martone, S. David, F. Schito, L. Urban, B. Di Iorio, F. Caruso, A. Mazzoni, R. Musacchio, D. Andreoli, M. Cossu, G. Li Cavoli, M. Cornacchiari, A. Granata, A. Clementi, R. Giordano, W. Barzaghi, M. Valentini, J. Hegbrant, G. Tognoni, G. F M Strippoli

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).

BACKGROUND: Anaemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested.

Original languageItalian
JournalGiornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia
Volume30
Issue number2
Publication statusPublished - Mar 1 2013

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Hematinics
Erythropoietin
Renal Dialysis
Quality of Life
Hemoglobins
Costs and Cost Analysis
Epoetin Alfa
Anemia
Clinical Protocols
Chronic Renal Insufficiency
Pharmaceutical Preparations
Chronic Kidney Failure
Observational Studies
Survival
Therapeutics
Research

ASJC Scopus subject areas

  • Nephrology

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Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi. / Saglimbene, V.; D'Alonzo, D.; Ruospo, M.; Vecchio, M.; Natale, P.; Gargano, L.; Nicolucci, A.; Pellegrini, F.; Craig, J. C.; Triolo, G.; Procaccini, D. A.; Santoro, A.; Di Giulio, S.; La Rosa, S.; Murgo, A.; Di Toro Mammarella, R.; Sambati, M.; D'Ambrosio, N.; Greco, V.; Giannoccaro, G.; Flammini, A.; Boccia, E.; Montalto, G.; Pagano, S.; Amarù, S.; Fici, M.; Lumaga, G. Barone; Mancini, E.; Veronesi, M.; Patregnani, L.; Querques, M.; Schiavone, P.; Chimienti, S.; Palumbo, R.; Di Franco, D.; Della Volpe, M.; Gori, E.; Salomone, M.; Iacono, A.; Moscoloni, M.; Treglia, A.; Casu, D.; Piras, A. M.; Di Silva, A.; Mandreoli, M.; Lopez, A.; Quarello, F.; Catizone, L.; Russo, G.; Forcellini, S.; Maccarone, M.; Catucci, G.; Di Paolo, B.; Stingone, A.; D'Angelo, B.; Guastoni, C.; Pasquali, S.; Minoretti, C.; Bellasi, A.; Boscutti, G.; Martone, M.; David, S.; Schito, F.; Urban, L.; Di Iorio, B.; Caruso, F.; Mazzoni, A.; Musacchio, R.; Andreoli, D.; Cossu, M.; Li Cavoli, G.; Cornacchiari, M.; Granata, A.; Clementi, A.; Giordano, R.; Barzaghi, W.; Valentini, M.; Hegbrant, J.; Tognoni, G.; Strippoli, G. F M.

In: Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia, Vol. 30, No. 2, 01.03.2013.

Research output: Contribution to journalArticle

Saglimbene, V, D'Alonzo, D, Ruospo, M, Vecchio, M, Natale, P, Gargano, L, Nicolucci, A, Pellegrini, F, Craig, JC, Triolo, G, Procaccini, DA, Santoro, A, Di Giulio, S, La Rosa, S, Murgo, A, Di Toro Mammarella, R, Sambati, M, D'Ambrosio, N, Greco, V, Giannoccaro, G, Flammini, A, Boccia, E, Montalto, G, Pagano, S, Amarù, S, Fici, M, Lumaga, GB, Mancini, E, Veronesi, M, Patregnani, L, Querques, M, Schiavone, P, Chimienti, S, Palumbo, R, Di Franco, D, Della Volpe, M, Gori, E, Salomone, M, Iacono, A, Moscoloni, M, Treglia, A, Casu, D, Piras, AM, Di Silva, A, Mandreoli, M, Lopez, A, Quarello, F, Catizone, L, Russo, G, Forcellini, S, Maccarone, M, Catucci, G, Di Paolo, B, Stingone, A, D'Angelo, B, Guastoni, C, Pasquali, S, Minoretti, C, Bellasi, A, Boscutti, G, Martone, M, David, S, Schito, F, Urban, L, Di Iorio, B, Caruso, F, Mazzoni, A, Musacchio, R, Andreoli, D, Cossu, M, Li Cavoli, G, Cornacchiari, M, Granata, A, Clementi, A, Giordano, R, Barzaghi, W, Valentini, M, Hegbrant, J, Tognoni, G & Strippoli, GFM 2013, 'Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi', Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia, vol. 30, no. 2.
Saglimbene, V. ; D'Alonzo, D. ; Ruospo, M. ; Vecchio, M. ; Natale, P. ; Gargano, L. ; Nicolucci, A. ; Pellegrini, F. ; Craig, J. C. ; Triolo, G. ; Procaccini, D. A. ; Santoro, A. ; Di Giulio, S. ; La Rosa, S. ; Murgo, A. ; Di Toro Mammarella, R. ; Sambati, M. ; D'Ambrosio, N. ; Greco, V. ; Giannoccaro, G. ; Flammini, A. ; Boccia, E. ; Montalto, G. ; Pagano, S. ; Amarù, S. ; Fici, M. ; Lumaga, G. Barone ; Mancini, E. ; Veronesi, M. ; Patregnani, L. ; Querques, M. ; Schiavone, P. ; Chimienti, S. ; Palumbo, R. ; Di Franco, D. ; Della Volpe, M. ; Gori, E. ; Salomone, M. ; Iacono, A. ; Moscoloni, M. ; Treglia, A. ; Casu, D. ; Piras, A. M. ; Di Silva, A. ; Mandreoli, M. ; Lopez, A. ; Quarello, F. ; Catizone, L. ; Russo, G. ; Forcellini, S. ; Maccarone, M. ; Catucci, G. ; Di Paolo, B. ; Stingone, A. ; D'Angelo, B. ; Guastoni, C. ; Pasquali, S. ; Minoretti, C. ; Bellasi, A. ; Boscutti, G. ; Martone, M. ; David, S. ; Schito, F. ; Urban, L. ; Di Iorio, B. ; Caruso, F. ; Mazzoni, A. ; Musacchio, R. ; Andreoli, D. ; Cossu, M. ; Li Cavoli, G. ; Cornacchiari, M. ; Granata, A. ; Clementi, A. ; Giordano, R. ; Barzaghi, W. ; Valentini, M. ; Hegbrant, J. ; Tognoni, G. ; Strippoli, G. F M. / Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi. In: Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia. 2013 ; Vol. 30, No. 2.
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abstract = "METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).BACKGROUND: Anaemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested.",
author = "V. Saglimbene and D. D'Alonzo and M. Ruospo and M. Vecchio and P. Natale and L. Gargano and A. Nicolucci and F. Pellegrini and Craig, {J. C.} and G. Triolo and Procaccini, {D. A.} and A. Santoro and {Di Giulio}, S. and {La Rosa}, S. and A. Murgo and {Di Toro Mammarella}, R. and M. Sambati and N. D'Ambrosio and V. Greco and G. Giannoccaro and A. Flammini and E. Boccia and G. Montalto and S. Pagano and S. Amar{\`u} and M. Fici and Lumaga, {G. Barone} and E. Mancini and M. Veronesi and L. Patregnani and M. Querques and P. Schiavone and S. Chimienti and R. Palumbo and {Di Franco}, D. and {Della Volpe}, M. and E. Gori and M. Salomone and A. Iacono and M. Moscoloni and A. Treglia and D. Casu and Piras, {A. M.} and {Di Silva}, A. and M. Mandreoli and A. Lopez and F. Quarello and L. Catizone and G. Russo and S. Forcellini and M. Maccarone and G. Catucci and {Di Paolo}, B. and A. Stingone and B. D'Angelo and C. Guastoni and S. Pasquali and C. Minoretti and A. Bellasi and G. Boscutti and M. Martone and S. David and F. Schito and L. Urban and {Di Iorio}, B. and F. Caruso and A. Mazzoni and R. Musacchio and D. Andreoli and M. Cossu and {Li Cavoli}, G. and M. Cornacchiari and A. Granata and A. Clementi and R. Giordano and W. Barzaghi and M. Valentini and J. Hegbrant and G. Tognoni and Strippoli, {G. F M}",
year = "2013",
month = "3",
day = "1",
language = "Italian",
volume = "30",
journal = "Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia",
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TY - JOUR

T1 - Effetti della dose degli agenti stimolanti l'eritropoiesi su esiti cardio-cerebrovascolari, qualità di vita e costi in emodialisi

AU - Saglimbene, V.

AU - D'Alonzo, D.

AU - Ruospo, M.

AU - Vecchio, M.

AU - Natale, P.

AU - Gargano, L.

AU - Nicolucci, A.

AU - Pellegrini, F.

AU - Craig, J. C.

AU - Triolo, G.

AU - Procaccini, D. A.

AU - Santoro, A.

AU - Di Giulio, S.

AU - La Rosa, S.

AU - Murgo, A.

AU - Di Toro Mammarella, R.

AU - Sambati, M.

AU - D'Ambrosio, N.

AU - Greco, V.

AU - Giannoccaro, G.

AU - Flammini, A.

AU - Boccia, E.

AU - Montalto, G.

AU - Pagano, S.

AU - Amarù, S.

AU - Fici, M.

AU - Lumaga, G. Barone

AU - Mancini, E.

AU - Veronesi, M.

AU - Patregnani, L.

AU - Querques, M.

AU - Schiavone, P.

AU - Chimienti, S.

AU - Palumbo, R.

AU - Di Franco, D.

AU - Della Volpe, M.

AU - Gori, E.

AU - Salomone, M.

AU - Iacono, A.

AU - Moscoloni, M.

AU - Treglia, A.

AU - Casu, D.

AU - Piras, A. M.

AU - Di Silva, A.

AU - Mandreoli, M.

AU - Lopez, A.

AU - Quarello, F.

AU - Catizone, L.

AU - Russo, G.

AU - Forcellini, S.

AU - Maccarone, M.

AU - Catucci, G.

AU - Di Paolo, B.

AU - Stingone, A.

AU - D'Angelo, B.

AU - Guastoni, C.

AU - Pasquali, S.

AU - Minoretti, C.

AU - Bellasi, A.

AU - Boscutti, G.

AU - Martone, M.

AU - David, S.

AU - Schito, F.

AU - Urban, L.

AU - Di Iorio, B.

AU - Caruso, F.

AU - Mazzoni, A.

AU - Musacchio, R.

AU - Andreoli, D.

AU - Cossu, M.

AU - Li Cavoli, G.

AU - Cornacchiari, M.

AU - Granata, A.

AU - Clementi, A.

AU - Giordano, R.

AU - Barzaghi, W.

AU - Valentini, M.

AU - Hegbrant, J.

AU - Tognoni, G.

AU - Strippoli, G. F M

PY - 2013/3/1

Y1 - 2013/3/1

N2 - METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).BACKGROUND: Anaemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested.

AB - METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).BACKGROUND: Anaemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested.

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M3 - Articolo

VL - 30

JO - Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia

JF - Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia

SN - 0393-5590

IS - 2

ER -