The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study.
The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study.
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基线特征，血糖治疗方法和糖化血红蛋白浓度对严重低血糖风险的影响：协定研究事后流行病学分析。
DOI：
10.1136/bmj.b5444
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发表时间：
2010-01-08
期刊：
影响因子：
--
通讯作者：
ACCORD Investigators
中科院分区：
文献类型：
--
作者：
Miller ME;Bonds DE;Gerstein HC;Seaquist ER;Bergenstal RM;Calles-Escandon J;Childress RD;Craven TE;Cuddihy RM;Dailey G;Feinglos MN;Ismail-Beigi F;Largay JF;O'Connor PJ;Paul T;Savage PJ;Schubart UK;Sood A;Genuth S;ACCORD Investigators
目的：在控制糖尿病心血管风险行动（ACCORD）试验中研究严重低血糖的潜在决定因素，包括基线特征，以及严重低血糖与治疗期间达到的糖化血红蛋白（血红蛋白A1C）水平的相关性。设计一项2 × 2析因、随机、对照试验的事后流行病学分析。设置糖尿病诊所，研究诊所和初级保健诊所。参加ACCORD研究的10251名参与者中有10209名患有2型糖尿病，筛选期间血红蛋白A1C浓度为7.5%或更高，年龄为40 - 79岁，患有心血管疾病或55 - 79岁，有明显的动脉粥样硬化、白蛋白尿、左心室肥大的证据，或两种或两种以上心血管疾病的其他风险因素（血脂异常、高血压、当前吸烟者或肥胖）。强化（血红蛋白A1C <6.0%）或标准（血红蛋白A1C 7.0 - 7.9%）血糖控制。主要结果测量重度低血糖定义为需要他人帮助的"低血糖"发作，并记录血糖低于2.8 mmol/l（<50 mg/dl）或口服碳水化合物、静脉注射葡萄糖或胰高血糖素后症状迅速消退。 结果强化治疗组低血糖年发生率为3.14%，标准治疗组低血糖年发生率为1.03%。我们发现女性（P = 0.0300）、非裔美国人（与非西班牙裔白人相比P <0.0001）、高中以下教育程度的人（与大学毕业生相比P <0.0500）、老年参与者（每增加1年P <0.0001）和在进入试验时使用胰岛素的人（P <0.0001）的低血糖风险显著增加。从基线至4个月访视，血红蛋白A1C浓度每下降1%单位，标准和强化治疗组中需要医疗救助的低血糖风险分别降低28%（95% CI 19%-37%）和14%（4%-23%）。在两个治疗组中，平均更新血红蛋白A1C浓度每增加1%单位，需要医疗救助的低血糖风险增加（标准组：风险比1.76，95% CI 1.50 - 2.06;强化组：风险比1.15，95% CI 1.02 - 1.21）。结论：从基线到4个月访视，血红蛋白A1C浓度的较大下降与低血糖风险增加无关。血糖控制较差的患者发生低血糖的风险更大，与治疗组无关。识别重度低血糖风险增加的基线亚组可以为临床医生根据个体风险调整患者治疗提供指导。试用注册www.example.com编号NCT 00000620。
Objectives To investigate potential determinants of severe hypoglycaemia, including baseline characteristics, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the association of severe hypoglycaemia with levels of glycated haemoglobin (haemoglobin A1C) achieved during therapy. Design Post hoc epidemiological analysis of a double 2×2 factorial, randomised, controlled trial. Setting Diabetes clinics, research clinics, and primary care clinics. Participants 10 209 of the 10 251 participants enrolled in the ACCORD study with type 2 diabetes, a haemoglobin A1C concentration of 7.5% or more during screening, and aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of significant atherosclerosis, albuminuria, left ventricular hypertrophy, or two or more additional risk factors for cardiovascular disease (dyslipidaemia, hypertension, current smoker, or obese). Interventions Intensive (haemoglobin A1C <6.0%) or standard (haemoglobin A1C 7.0-7.9%) glucose control. Main outcome measures Severe hypoglycaemia was defined as episodes of “low blood glucose” requiring the assistance of another person and documentation of either a plasma glucose less than 2.8 mmol/l (<50 mg/dl) or symptoms that promptly resolved with oral carbohydrate, intravenous glucose, or glucagon. Results The annual incidence of hypoglycaemia was 3.14% in the intensive treatment group and 1.03% in the standard glycaemia group. We found significantly increased risks for hypoglycaemia among women (P=0.0300), African-Americans (P<0.0001 compared with non-Hispanic whites), those with less than a high school education (P<0.0500 compared with college graduates), aged participants (P<0.0001 per 1 year increase), and those who used insulin at trial entry (P<0.0001). For every 1% unit decline in the haemoglobin A1C concentration from baseline to 4 month visit, there was a 28% (95% CI 19% to 37%) and 14% (4% to 23%) reduced risk of hypoglycaemia requiring medical assistance in the standard and intensive groups, respectively. In both treatment groups, the risk of hypoglycaemia requiring medical assistance increased with each 1% unit increment in the average updated haemoglobin A1C concentration (standard arm: hazard ratio 1.76, 95% CI 1.50 to 2.06; intensive arm: hazard ratio 1.15, 95% CI 1.02 to 1.21). Conclusions A greater drop in haemoglobin A1C concentration from baseline to the 4 month visit was not associated with an increased risk for hypoglycaemia. Patients with poorer glycaemic control had a greater risk of hypoglycaemia, irrespective of treatment group. Identification of baseline subgroups with increased risk for severe hypoglycaemia can provide guidance to clinicians attempting to modify patient therapy on the basis of individual risk. Trial registration ClinicalTrials.gov number NCT00000620.
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影响因子：
168.9
作者：
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通讯作者：
Ward, JD
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