A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease
A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease
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DOI：
10.1056/nejmoa0907845
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发表时间：
2009-11-19
影响因子：
158.5
通讯作者：
Toto, Robert
中科院分区：
文献类型：
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作者：
Pfeffer, Marc A.;Burdmann, Emmanuel A.;Toto, Robert
背景：在2型糖尿病和慢性肾脏疾病患者中，贫血与心血管和肾脏事件的风险增加相关。虽然达贝泊汀可以有效地提高血红蛋白水平，但其对这些患者临床结果的影响尚未得到充分的测试。方法本研究纳入4038例糖尿病、慢性肾脏疾病和贫血患者，随机分配2012例患者使用达贝泊汀治疗，以达到血红蛋白水平约为13 g /分升，2026例患者使用安慰剂，当血红蛋白水平低于9.0 g /分升时，使用达贝泊汀治疗。主要终点是死亡或心血管事件（非致死性心肌梗死、充血性心力衰竭、中风或因心肌缺血住院）和死亡或终末期肾病的复合结局。结果：632例达贝泊汀组患者和602例安慰剂组患者发生死亡或心血管事件（达贝泊汀与安慰剂的风险比为1.05；95%可信区间[CI]， 0.94 ~ 1.17; P = 0.41）。652例达贝泊汀组患者和618例安慰剂组患者发生死亡或终末期肾病（风险比为1.06；95% CI为0.95 ~ 1.19;P = 0.29）。101名接受达贝泊汀治疗的患者和53名接受安慰剂治疗的患者发生了致死性或非致死性卒中(风险比1.92;95% CI, 1.38 ~ 2.68； P
BACKGROUNDAnemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested.METHODSIn this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease.RESULTSDeath or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo ( hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P = 0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo ( hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P = 0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo ( hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P