Anemia normalization in patients with type 2 diabetes and chronic kidney disease: results of the NEPHRODIAB2 randomized trial

• Published in: Journal of diabetes and its complications Vol. 25; no. 4; pp. 237 - 243
• Main Authors: Villar, Emmanuel, Lièvre, Michel, Kessler, Michèle, Lemaître, Vincent, Alamartine, Eric, Rodier, Michel, François, Maud, Zaoui, Philippe, Moranne, Olivier, Choukroun, Gabriel, Guerraoui, Abdallah, Jolivot, Anne, Janin, Gérard, Branger, Bernard, Heng, Anne-Elisabeth, Boudray, Catherine, Bissery, Alvine, Rabilloud, Muriel, Pouteil-Noble, Claire
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2011; Elsevier Limited
• Subjects: Aged; Anemia; Anemia - complications; Anemia - drug therapy; Anemia - economics; Cardiovascular Diseases - epidemiology; Chronic kidney disease; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - psychology; Diabetic Nephropathies - complications; Diabetic Nephropathies - physiopathology; Diabetic Nephropathies - psychology; Disease; Disease Progression; Drug Costs; Drug Monitoring; Drug therapy; Endocrinology & Metabolism; Erythropoiesis-stimulating agent; Erythropoietin - administration & dosage; Erythropoietin - adverse effects; Erythropoietin - economics; Erythropoietin - therapeutic use; Female; France - epidemiology; Glomerular filtration rate; Heart attacks; Hematinics - administration & dosage; Hematinics - adverse effects; Hematinics - economics; Hematinics - therapeutic use; Hemoglobins - analysis; Humans; Iron - adverse effects; Iron - therapeutic use; Kidney diseases; Male; Middle Aged; Practice Guidelines as Topic; Quality of Life; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - physiopathology; Renal Insufficiency, Chronic - psychology; Risk Factors; Severity of Illness Index; Skin cancer; Statistical analysis; Statistical methods; Type 2 diabetes; France; Type 2 diabetes; Chronic kidney disease; Anemia; Erythropoiesis-stimulating agent; Glomerular filtration rate
• ISSN: 1056-8727; 1873-460X
• DOI: 10.1016/j.jdiacomp.2011.03.003

Abstract Statements of the Problem Correction of anemia in type 2 diabetes (T2DM) patients with chronic kidney disease stages 3–4 may slow the decline of kidney function but may increase cardiovascular risk through higher hematocrit. The NEPHRODIAB2 study was designed to assess efficacy and safety of complete hemoglobin (Hb) normalization in these patients. Methods We randomly assigned 89 T2DM patients with an estimated glomerular filtration rate (eGFR; abbreviated 175 Modification of Diet in Renal Disease formula) of 25 to 60 ml/min per 1.73 m2 and moderate anemia (Hb, 100–129 g/l) to a target Hb value in subnormal range (110–129g/l, group 1, n =43) or normal range (130–149 g/l, group 2, n =46). The primary end point was eGFR decline after 2 years of follow-up. Secondary end points included iron and erythropoietin dosage, quality of life (Medical Outcomes Study 36-item Short-Form Health Survey scores) and adverse events. Results Six months after randomization, the mean Hb levels were <120 g/l in group 1 and >130 g/l in group 2 ( P <.05 at 6, 12, 18 and 24 months). Blood pressure, 24-h proteinuria and HbA1c did not differ during follow-up ( P >.05). Two-year declines in eGFR were −8.7±12.2 in group 1 and −5.1±7.8 ml/min per 1.73 m2 in group 2 ( P =.29). Mean weekly use of erythropoietin was 7.8±11.6 μg in group 1 and 30.1±33.6 μg in group 2 ( P <.0001). There was no significant difference regarding Medical Outcomes Study 36-item Short-Form Health Survey score change or adverse event occurrence. Conclusions In this trial, normalization of Hb level in T2DM patients with chronic kidney disease was safe but did not significantly slow renal function decline and increased treatment cost due to erythropoietin use.