TY - JOUR
T1 - Hemoglobin stability in patients with anemia, CKD, and type 2 diabetes
T2 - An analysis of the TREAT (trial to reduce cardiovascular events with aranesp therapy) placebo arm
AU - Skali, Hicham
AU - Lin, Julie
AU - Pfeffer, Marc A.
AU - Chen, Chao Yin
AU - Cooper, Mark E.
AU - McMurray, John J V
AU - Nissenson, Allen R.
AU - Remuzzi, Giuseppe
AU - Rossert, Jerome
AU - Parfrey, Patrick S.
AU - Scott-Douglas, Nairne W.
AU - Singh, Ajay K.
AU - Toto, Robert
AU - Uno, Hajime
AU - Ivanovich, Peter
N1 - Funding Information:
Financial Disclosure: Dr Lin reports institutional and indirect receipt of support for travel expenses and fees for participation in review activities, such as data monitoring boards, statistical analysis, or end point committees. Dr Lin also reports being an employee of Amgen as of April 2012 and holding stock/stock options in Amgen. Dr Pfeffer reports institutional receipt of research support from Amgen, Novartis, and Sanofi-Aventis, as well as indirect receipt of consulting fees from Anthera, Boehringer, Bristol-Myers Squibb, GlaxoSmithKline, Hamilton Health Sciences, Merck, Karo Bio, NicOx, Novartis, Roche, Sanofi-Aventis, Servier, and University of Oxford. The Brigham and Women's Hospital has patents for the use of renin-angiotensin system inhibitors in selected survivors of myocardial infarction with Novartis Pharmaceuticals AG and Boehringer Ingelheim, GMBH; Dr Pfeffer is a co-inventor; his share of the licensing agreements is irrevocably transferred to charity. Dr Chen reports being an employee of Amgen and holding Amgen stock/stock options. Dr Cooper reports receiving consultancy fees from Amgen that are outside the scope of this work. Dr McMurray reports that his employer, Glasgow University, has been paid for his time spent on the Executive and Steering Committees of the TREAT and RED-HF trials (with darbepoetin) and the ATOMIC-HF trial with omecamtiv mercarbil. Dr McMurray has been paid travel and accommodation expenses to attend Executive/Steering Committee meetings for these trials. Dr Nissenson reported being an employee of DaVita Inc and holding DaVita stocks. Dr Remuzzi does not accept any personal remuneration; consultancy compensations from Alexion Pharmaceuticals, Abbott, and Reata Pharmaceuticals are paid to his institution for research and educational activities outside the nephrology division. Dr Parfrey's institution has received fees from Amgen for his role as Executive Committee member of TREAT and as co-chair of the executive committee of EVOLVE, He has received funds for travel and speakers fees from Amgen. Dr Rossert reports being an employee of Amgen and holding Amgen stock/stock options. Dr Scott-Douglas reports receiving research clinical trial support from Amgen and Hoffmann La Roche; receiving speaker or advisory board honoraria from Novartis, Hoffmann La Roche, and Takeda Phamaceuticals; and receiving unrestricted educational grants for trainee education from Amgen , Servier , and Pfizer . Dr Singh reports receipt of consulting fees and support for travel to meetings for the study or other purposes from Amgen, and relevant but outside the scope of this work, he reports consultancy from IHS Dialysis, Sandoz, Rockwell, and Concert, as well as payment for lectures from Joslin, Harvard, and the American Society of Nephrology. Dr Toto reports receipt of grant support, consulting fees, support for travel, and fees for participation in review activities such as data monitoring boards and statistical analysis and end point committees from Amgen , and relevant but outside the scope of this work, he reports board membership for Boehringer Ingelheim, consultancy for Amgen, grants/grants pending from Reata , and payment for lectures on speakers bureaus from Amgen. Dr Ivanovich reports receipt of consulting fees or honorarium from Baxter and Amgen, and relevant but outside the scope of this work, he reports receipt of fees from Reata and Applied Clinical Intelligence for serving on data safety monitoring boards. Drs Skali and Uno have no disclosures to report.
PY - 2013/2
Y1 - 2013/2
N2 - Background: Sparse data are available about the natural history of hemoglobin (Hb) level trends in contemporary patients with anemia, chronic kidney disease (CKD), and type 2 diabetes mellitus. We intended to describe Hb level trends over time with no or minimal administration of erythropoiesis- stimulating agents. Study Design: Prospective clinical trial cohort. Setting & Participants: 2,019 individuals with type 2 diabetes, moderate anemia, and CKD from the placebo arm of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) followed up for 2.3 years with an average of 32 monthly Hb level determinations per patient. Darbepoetin alfa was administered only if Hb level decreased to <9 g/dL. Outcomes & Measurements: Number of protocol-directed doses of darbepoetin alfa received due to an Hb level decrease to <9 g/dL. Results: 1,106 (55%) placebo patients consistently maintained an Hb level ≥9 g/dL and received no protocol-directed darbepoetin alfa. The other patients received 1 (16%), 2-4 (16%), or 5 or more (13%) doses of darbepoetin alfa. Those who received no darbepoetin alfa doses had higher baseline Hb levels, higher estimated glomerular filtration rates (eGFRs), less proteinuria, and lower ferritin and transferrin saturation values. On average, Hb levels were stable or increased in all groups. Compared with individuals who received no darbepoetin alfa, those who received 5 or more doses were more likely to receive intravenous iron therapy and blood transfusions and progress to renal replacement therapy, but were not at higher risk of death. The strongest predictors of requiring 5 or more doses of darbepoetin alfa were lower baseline Hb level, lower eGFR, and higher proteinuria level. Limitations: Post hoc analysis of a clinical trial of a specific population with diabetes, anemia, and non-dialysis-dependent CKD. Conclusions: In the TREAT placebo arm, Hb levels were stable with no or minimal protocol-directed darbepoetin alfa during 2.3 years of follow-up. Most patients with moderate anemia, non-dialysis- dependent CKD, and type 2 diabetes are able to maintain a stable Hb level without implementing long-term erythropoiesis-stimulating agent therapy.
AB - Background: Sparse data are available about the natural history of hemoglobin (Hb) level trends in contemporary patients with anemia, chronic kidney disease (CKD), and type 2 diabetes mellitus. We intended to describe Hb level trends over time with no or minimal administration of erythropoiesis- stimulating agents. Study Design: Prospective clinical trial cohort. Setting & Participants: 2,019 individuals with type 2 diabetes, moderate anemia, and CKD from the placebo arm of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) followed up for 2.3 years with an average of 32 monthly Hb level determinations per patient. Darbepoetin alfa was administered only if Hb level decreased to <9 g/dL. Outcomes & Measurements: Number of protocol-directed doses of darbepoetin alfa received due to an Hb level decrease to <9 g/dL. Results: 1,106 (55%) placebo patients consistently maintained an Hb level ≥9 g/dL and received no protocol-directed darbepoetin alfa. The other patients received 1 (16%), 2-4 (16%), or 5 or more (13%) doses of darbepoetin alfa. Those who received no darbepoetin alfa doses had higher baseline Hb levels, higher estimated glomerular filtration rates (eGFRs), less proteinuria, and lower ferritin and transferrin saturation values. On average, Hb levels were stable or increased in all groups. Compared with individuals who received no darbepoetin alfa, those who received 5 or more doses were more likely to receive intravenous iron therapy and blood transfusions and progress to renal replacement therapy, but were not at higher risk of death. The strongest predictors of requiring 5 or more doses of darbepoetin alfa were lower baseline Hb level, lower eGFR, and higher proteinuria level. Limitations: Post hoc analysis of a clinical trial of a specific population with diabetes, anemia, and non-dialysis-dependent CKD. Conclusions: In the TREAT placebo arm, Hb levels were stable with no or minimal protocol-directed darbepoetin alfa during 2.3 years of follow-up. Most patients with moderate anemia, non-dialysis- dependent CKD, and type 2 diabetes are able to maintain a stable Hb level without implementing long-term erythropoiesis-stimulating agent therapy.
KW - Anemia
KW - erythropoiesis-stimulating agents
KW - placebo
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U2 - 10.1053/j.ajkd.2012.08.043
DO - 10.1053/j.ajkd.2012.08.043
M3 - Article
C2 - 23159232
AN - SCOPUS:84872308317
VL - 61
SP - 238
EP - 246
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
SN - 0272-6386
IS - 2
ER -