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

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• 作者：Emmanuel Villar^a ; ^{emmanuel.villar@chu-lyon.fr" rel="nofollow} ; Michel Liè ; vre^b ; ^c ; Michè ; le Kessler^d ; Vincent Lemaî ; tre^e ; Eric Alamartine^f ; Michel Rodier^g ; Maud Franç ; ois^h ; Philippe Zaouiⁱ ; Olivier Moranne^j ; Gabriel Choukroun^k ; Abdallah Guerraoui^l ; Anne Jolivot^m ; Gé ; rard Janinⁿ ; Bernard Branger^o ; Anne-Elisabeth Heng^p ; Catherine Boudray^q ; Alvine Bissery^r ; Muriel Rabilloud^c ; ^r ; Claire Pouteil-Noble^a ; ^c
• 关键词：Anemia ; Chronic kidney disease ; Erythropoiesis-stimulating agent ; Glomerular filtration rate ; Type 2 diabetes
• 刊名：Journal of Diabetes and its Complications
• 出版年：2011
• 出版时间：July-August 2011
• 年：2011
• 卷：25
• 期：4
• 页码：237-243
• 全文大小：231 K
• ISSN：S1056872711000389

文摘

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 &#x2212;8.7±12.2 in group 1 and &#x2212;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.