Darbepoetin Alfa impact on health status in diabetes patients with kidney disease

A randomized trial

Eldrin F. Lewis, Marc A. Pfeffer, Amy Feng, Hajime Uno, John J V McMurray, Robert Toto, Shravanthi R. Gandra, Scott D. Solomon, Moustafa Moustafa, Iain C. Macdougall, Francesco Locatelli, Patrick S. Parfrey

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Background and objectives Quality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. Design, setting, participants, & measurements In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated GFR, 20 to 60 ml/min per 1.73 m2), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks. Results Patients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function. Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision.

Original languageEnglish (US)
Pages (from-to)845-855
Number of pages11
JournalClinical Journal of the American Society of Nephrology
Volume6
Issue number4
DOIs
StatePublished - Apr 1 2011

Fingerprint

Kidney Diseases
Health Status
Quality of Life
Fatigue
Anemia
Chronic Renal Insufficiency
Therapeutics
Stroke
Placebos
Darbepoetin alfa
Double-Blind Method
Type 2 Diabetes Mellitus
Lung Diseases
Neoplasms
Diabetes Mellitus
Hemoglobins

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

Darbepoetin Alfa impact on health status in diabetes patients with kidney disease : A randomized trial. / Lewis, Eldrin F.; Pfeffer, Marc A.; Feng, Amy; Uno, Hajime; McMurray, John J V; Toto, Robert; Gandra, Shravanthi R.; Solomon, Scott D.; Moustafa, Moustafa; Macdougall, Iain C.; Locatelli, Francesco; Parfrey, Patrick S.

In: Clinical Journal of the American Society of Nephrology, Vol. 6, No. 4, 01.04.2011, p. 845-855.

Research output: Contribution to journalArticle

Lewis, EF, Pfeffer, MA, Feng, A, Uno, H, McMurray, JJV, Toto, R, Gandra, SR, Solomon, SD, Moustafa, M, Macdougall, IC, Locatelli, F & Parfrey, PS 2011, 'Darbepoetin Alfa impact on health status in diabetes patients with kidney disease: A randomized trial', Clinical Journal of the American Society of Nephrology, vol. 6, no. 4, pp. 845-855. https://doi.org/10.2215/CJN.06450710
Lewis, Eldrin F. ; Pfeffer, Marc A. ; Feng, Amy ; Uno, Hajime ; McMurray, John J V ; Toto, Robert ; Gandra, Shravanthi R. ; Solomon, Scott D. ; Moustafa, Moustafa ; Macdougall, Iain C. ; Locatelli, Francesco ; Parfrey, Patrick S. / Darbepoetin Alfa impact on health status in diabetes patients with kidney disease : A randomized trial. In: Clinical Journal of the American Society of Nephrology. 2011 ; Vol. 6, No. 4. pp. 845-855.
@article{6fd251ae395040dfae2e6a9c03ca4b23,
title = "Darbepoetin Alfa impact on health status in diabetes patients with kidney disease: A randomized trial",
abstract = "Background and objectives Quality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. Design, setting, participants, & measurements In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated GFR, 20 to 60 ml/min per 1.73 m2), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks. Results Patients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function. Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision.",
author = "Lewis, {Eldrin F.} and Pfeffer, {Marc A.} and Amy Feng and Hajime Uno and McMurray, {John J V} and Robert Toto and Gandra, {Shravanthi R.} and Solomon, {Scott D.} and Moustafa Moustafa and Macdougall, {Iain C.} and Francesco Locatelli and Parfrey, {Patrick S.}",
year = "2011",
month = "4",
day = "1",
doi = "10.2215/CJN.06450710",
language = "English (US)",
volume = "6",
pages = "845--855",
journal = "Clinical Journal of the American Society of Nephrology",
issn = "1555-9041",
publisher = "American Society of Nephrology",
number = "4",

}

TY - JOUR

T1 - Darbepoetin Alfa impact on health status in diabetes patients with kidney disease

T2 - A randomized trial

AU - Lewis, Eldrin F.

AU - Pfeffer, Marc A.

AU - Feng, Amy

AU - Uno, Hajime

AU - McMurray, John J V

AU - Toto, Robert

AU - Gandra, Shravanthi R.

AU - Solomon, Scott D.

AU - Moustafa, Moustafa

AU - Macdougall, Iain C.

AU - Locatelli, Francesco

AU - Parfrey, Patrick S.

PY - 2011/4/1

Y1 - 2011/4/1

N2 - Background and objectives Quality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. Design, setting, participants, & measurements In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated GFR, 20 to 60 ml/min per 1.73 m2), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks. Results Patients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function. Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision.

AB - Background and objectives Quality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. Design, setting, participants, & measurements In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated GFR, 20 to 60 ml/min per 1.73 m2), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks. Results Patients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function. Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision.

UR - http://www.scopus.com/inward/record.url?scp=79955568764&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79955568764&partnerID=8YFLogxK

U2 - 10.2215/CJN.06450710

DO - 10.2215/CJN.06450710

M3 - Article

VL - 6

SP - 845

EP - 855

JO - Clinical Journal of the American Society of Nephrology

JF - Clinical Journal of the American Society of Nephrology

SN - 1555-9041

IS - 4

ER -