Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1063, USA.
BMJ. 2010 Jan 8;340:b5444. doi: 10.1136/bmj.b5444.
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 A(1C)) achieved during therapy.
Post hoc epidemiological analysis of a double 2x2 factorial, randomised, controlled trial.
Diabetes clinics, research clinics, and primary care clinics.
10 209 of the 10 251 participants enrolled in the ACCORD study with type 2 diabetes, a haemoglobin A(1C) 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 A(1C) <6.0%) or standard (haemoglobin A(1C) 7.0-7.9%) glucose control.
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.
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 A(1C) 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 A(1C) 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).
A greater drop in haemoglobin A(1C) 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.
ClinicalTrials.gov number NCT00000620.
研究严重低血糖的潜在决定因素，包括基线特征，在心血管风险行动控制糖尿病（ACCORD）试验和严重低血糖与治疗期间达到的糖化血红蛋白（血红蛋白 A1C）水平之间的关系。
一项双 2x2 析因、随机、对照试验的事后流行病学分析。
糖尿病诊所、研究诊所和初级保健诊所。
10251 名 ACCORD 研究中的 10209 名参与者，年龄在 40-79 岁之间，患有 2 型糖尿病，在筛选期间有 7.5%或更高的血红蛋白 A1C 浓度，并且有已确诊的心血管疾病或 55-79 岁，有明显的动脉粥样硬化、白蛋白尿、左心室肥厚或两个或更多心血管疾病的其他危险因素（血脂异常、高血压、当前吸烟者或肥胖）。干预措施强化（血红蛋白 A1C<6.0%）或标准（血红蛋白 A1C7.0-7.9%）血糖控制。
严重低血糖定义为需要他人协助的“低血糖”发作，并记录血浆葡萄糖<2.8mmol/l（<50mg/dl）或症状迅速缓解的情况，经口服碳水化合物、静脉葡萄糖或胰高血糖素。
强化治疗组低血糖年发生率为 3.14%，标准血糖组为 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）、受教育程度较低的人（与大学毕业者相比，P<0.0500）、年龄较大的参与者（每增加 1 岁，P<0.0001）和在试验开始时使用胰岛素的人（P<0.0001）发生低血糖的风险显著增加。与基线相比，血红蛋白 A1C 浓度在 4 个月时下降 1%，标准组和强化组低血糖需要医疗帮助的风险分别降低 28%（95%CI19%至 37%）和 14%（4%至 23%）。在两组治疗中，平均更新的血红蛋白 A1C 浓度每增加 1%，低血糖需要医疗帮助的风险就会增加（标准臂：危险比 1.76，95%CI1.50 至 2.06；强化臂：危险比 1.15，95%CI1.02 至 1.21）。
从基线到 4 个月时血红蛋白 A1C 浓度的下降幅度较大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高，无论治疗组如何。确定严重低血糖风险增加的基线亚组可为临床医生根据个体风险调整患者治疗提供指导。
ClinicalTrials.gov 编号 NCT00000620。
Zotero 插件
