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[交流] ADA2009会议摘要 -7 ACCORD研究的基线特征与死亡率

Baseline Characteristics and Mortality in ACCORD

The intensive glycemia intervention (INT) of ACCORD (target A1C <6%) was discontinued after 3.5 ys due to an increase in all-cause mortality in INT vs standard glycemia (STD) treatment. This has raised questions about implementation of INT in patients with type 2 diabetes (T2DM) as 2 other trials (ADVANCE and VADT) did not demonstrate an adverse effect of INT on mortality risk. To determine if baseline clinical features can identify individuals less suitable for intensive glycemia control, we undertook an analysis of the relationship between baseline characteristics of the patients in ACCORD and all-cause mortality at the time of discontinuation of INT. Of 10,251 patients, 460 deaths were observed over 3.5 years of mean follow up (257 INT, 203 STD). Three baseline characteristics demonstrated statistical interactions with increased mortality in the INT vs STD: HbA1c ≥8.5% (HR 1.64 [1.22–2.22]) vs. Hba1c < 8.5 (HR 1.00 [0.79-1.27]), p value for interaction=0.01; self-reported history of neuropathy (HR = 1.95 [1.41-2.69]) vs. no history (HR 1.00 [0.79-1.26]) , p-value=0.0008; and use of aspirin (HR = 1.45[1.13–1.85]) vs. no use (HR 0.96[0.72-1.27]), p-value=0.03. Other variables (including diabetes duration, any oral agent, insulin use, BP medications, statin use, history of prior CVD, etc) did not have significant interactions with treatment on mortality. The finding that higher A1C had a higher mortality risk with INT may be explained by either biological (more severe disease, greater difficulty with intensification) or behavioral causes (limited adherence and/or understanding of complex treatment approach). The relationship between baseline HbA1c and mortality suggests a threshold effect on the risk of death (inflection point = 8.5%) rather than a continuous relationship. Baseline neuropathy and/or aspirin use may indicate higher baseline cardiovascular risk (cardiac neuropathy for the former and pre-existing or more extensive CVD for the latter). In summary, our data indicates that baseline A1c > 8.5%, a prior clinical history of neuropathy and/or use of aspirin may identify patients with T2DM at higher risk of mortality when very intensive glycemia treatment is implemented.

ACCORD研究的基线特征与死亡率
在ACCORD研究中，由于强化降糖组(INT)（目标A1C <6%）全因死亡率较常规治疗组(STD)增加，因此于干预3.5年时被提前终止。和其他两项研究（ADVANCE和VADT）结果一样，强化降糖都没有降低死亡发生风险。我们分析了ACCORD研究强化降糖组中患者基线特征与死亡率之间的关系，以明确基线特征是否能够作为判定这些患者不适宜进行强化降糖的依据。研究纳入患者共10,251例，3.5年中460例死亡（INT 257例，STD 203例）。其中与INT死亡率增加有统计学相关性的基线特征是：HbA1c ≥8.5% (HR 1.64 [1.22–2.22]) vs. HbA1c < 8.5 (HR 1.00 [0.79-1.27]), p=0.01；自我报告神经病变史(HR = 1.95 [1.41-2.69]) vs. 无病史 (HR 1.00 [0.79-1.26]) , p =0.0008；使用阿司匹林(HR = 1.45[1.13–1.85]) vs. 未使用 (HR 0.96[0.72-1.27]), p =0.03。其他变量与死亡率无显著关系（包括病程长短、任意口服降糖药、使用胰岛素、降压药、使用他汀、既往CVD病史等）。生物学（更多严重疾病，强化降糖更困难）或行为学（依从性有限和/或对复杂治疗方案理解有限）因素可能用于解释强化降糖组中A1C较高的患者死亡率较高的原因。HbA1c与死亡率之间的关系说明二者之间存在域效应而不存在连续效应。基线神经病变和/或使用阿司匹林可能表明这些患者基线心血管风险更高（前者表明心脏神经病变，后者说表明之前存在CVD或者CVD更严重）。这些数据说明，基线A1c > 8.5%、有神经病变史和/或阿司匹林用药史的2型糖尿病患者强化降糖死亡风险更高。
本文转自诺贝尔学术资源网 http://bbs.ok6ok.com/read.php?tid=362386

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