Long-term effects of intensive glucose lowering on cardiovascular outcomes.
Long-term effects of intensive glucose lowering on cardiovascular outcomes.
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DOI：
10.1056/nejmoa1006524
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发表时间：
2011-03-03
期刊：
影响因子：
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通讯作者：
Friedewald WT
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文献类型：
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作者：
ACCORD Study Group;Gerstein HC;Miller ME;Genuth S;Ismail-Beigi F;Buse JB;Goff DC Jr;Probstfield JL;Cushman WC;Ginsberg HN;Bigger JT;Grimm RH Jr;Byington RP;Rosenberg YD;Friedewald WT
先前的研究表明，强化降糖会增加晚期2型糖尿病患者和心血管疾病高风险患者的死亡率。本报告描述了平均3.7年强化降糖对死亡率和主要心血管事件的5年结果。我们随机分配患有2型糖尿病和心血管疾病或其他心血管危险因素的参与者接受强化治疗（目标是糖化血红蛋白水平低于6.0%）或标准治疗（目标是糖化血红蛋白水平在7%至7.9%之间）。在强化治疗结束后，由于强化治疗组的死亡率较高，所有参与者的目标糖化血红蛋白水平为7%至7.9%，一直随访到试验计划结束。在强化治疗结束前，强化治疗组与标准治疗组在主要结局（非致死性心肌梗死、非致死性卒中或心血管原因死亡的综合结果）的发生率上没有显著差异（P = 0.13），但任何原因（主要是心血管原因）的死亡较多（风险比为1.21；95%可信区间[CI]为1.02至1.44），非致死性心肌梗死较少（风险比为0.79；95% CI为0.66至0.95）。这些趋势在整个随访期间持续存在（死亡风险比为1.19；95% CI为1.03 ~ 1.38；非致死性心肌梗死风险比为0.82；95% CI为0.70 ~ 0.96）。强化干预结束后，强化治疗组中位糖化血红蛋白水平由6.4%上升至7.2%，两组降糖药物使用情况、严重低血糖及其他不良事件发生率相似。与标准治疗相比，使用3.7年的强化治疗使糖化血红蛋白水平低于6%，降低了5年非致死性心肌梗死，但增加了5年死亡率。这种策略不能推荐给高风险的晚期2型糖尿病患者。（由国家心脏、肺和血液研究所资助；ClinicalTrials.gov编号NCT00000620。）
Intensive glucose lowering has previously been shown to increase mortality among persons with advanced type 2 diabetes and a high risk of cardiovascular disease. This report describes the 5-year outcomes of a mean of 3.7 years of intensive glucose lowering on mortality and key cardiovascular events. We randomly assigned participants with type 2 diabetes and cardiovascular disease or additional cardiovascular risk factors to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level of 7 to 7.9%). After termination of the intensive therapy, due to higher mortality in the intensive-therapy group, the target glycated hemoglobin level was 7 to 7.9% for all participants, who were followed until the planned end of the trial. Before the intensive therapy was terminated, the intensive-therapy group did not differ significantly from the standard-therapy group in the rate of the primary outcome (a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) (P = 0.13) but had more deaths from any cause (primarily cardiovascular) (hazard ratio, 1.21; 95% confidence interval [CI], 1.02 to 1.44) and fewer nonfatal myocardial infarctions (hazard ratio, 0.79; 95% CI, 0.66 to 0.95). These trends persisted during the entire follow-up period (hazard ratio for death, 1.19; 95% CI, 1.03 to 1.38; and hazard ratio for nonfatal myocardial infarction, 0.82; 95% CI, 0.70 to 0.96). After the intensive intervention was terminated, the median glycated hemoglobin level in the intensive-therapy group rose from 6.4% to 7.2%, and the use of glucose-lowering medications and rates of severe hypoglycemia and other adverse events were similar in the two groups. As compared with standard therapy, the use of intensive therapy for 3.7 years to target a glycated hemoglobin level below 6% reduced 5-year nonfatal myocardial infarctions but increased 5-year mortality. Such a strategy cannot be recommended for high-risk patients with advanced type 2 diabetes. (Funded by the National Heart, Lung and Blood Institute; ClinicalTrials.gov number, NCT00000620.)