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

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 m(2) 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 m(2) 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.

• Authors: Emmanuel Villar, Michel Lièvre, Michèle Kessler, Vincent Lemaître, Eric Alamartine, Michel Rodier, Maud François, Philippe Zaoui, Olivier Moranne, Gabriel Choukroun, Abdallah Guerraoui, Anne Jolivot, Gérard Janin, Bernard Branger, Anne-Elisabeth Heng, Catherine Boudray, Alvine Bissery, Muriel Rabilloud, Claire Pouteil-Noble
• Journal: Journal of diabetes and its complications (J Diabetes Complications) 2011 Jul-Aug Vol. 25 Issue 4 Pg. 237-43 ISSN: 1873-460X [Electronic] United States
• PMID: 21601481 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier Inc. All rights reserved.

Chemical References

• Hematinics
• Hemoglobins
• Erythropoietin
• Iron

Topics

• Aged
• Anemia (complications, drug therapy, economics)
• Cardiovascular Diseases (epidemiology)
• Diabetes Mellitus, Type 2 (blood, complications, psychology)
• Diabetic Nephropathies (complications, physiopathology, psychology)
• Disease Progression
• Drug Costs
• Drug Monitoring
• Erythropoietin (administration & dosage, adverse effects, economics, therapeutic use)
• Female
• France (epidemiology)
• Hematinics (administration & dosage, adverse effects, economics, therapeutic use)
• Hemoglobins (analysis)
• Humans
• Iron (adverse effects, therapeutic use)
• Male
• Middle Aged
• Practice Guidelines as Topic
• Quality of Life
• Renal Insufficiency, Chronic (complications, physiopathology, psychology)
• Risk Factors
• Severity of Illness Index