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抗谷氨酸脱羧酶抗体阳性和阴性受试者中基础胰岛素治疗与标准治疗结局的关联:ORIGIN 试验的事后分析。

The association of basal insulin treatment versus standard care with outcomes in anti-GAD positive and negative subjects: A post-hoc analysis of the ORIGIN trial.

机构信息

Department of Transplantation Medicine, Institute of Clinical Medicine, University of Oslo and Oslo University Hospital, Oslo, Norway.

Department of Endocrinology, St. Olav's Hospital, Trondheim, Norway.

出版信息

Diabetes Obes Metab. 2019 Feb;21(2):429-433. doi: 10.1111/dom.13528. Epub 2018 Oct 3.

DOI:10.1111/dom.13528
PMID:30203580
Abstract

We compared cardiovascular and other outcomes in patients with dysglycaemia with or without anti-glutamic acid dehydrogenase (GAD) antibodies participating in the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial. Of the 12 537 participants, 8162 had anti-GAD measured at baseline and 267 were anti-GAD positive. The effects of insulin glargine versus standard care and of n-3 fatty acids supplements versus placebo were compared by testing the interaction of the treatment effects and anti-GAD status. The effect of glargine on development of new diabetes was assessed in participants without previous diabetes at baseline. The overall incidence of outcomes did not differ between anti-GAD positive and anti-GAD negative subjects. The incidence of the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke did not differ between anti-GAD positive participants randomized to insulin glargine or to standard care, with a hazard ratio (HR) (95% confidence interval [CI]) of 0.80 (0.44-1.44) or in anti-GAD negative participants with a HR of 1.07 (0.96-1.20) (P for interaction = 0.20).

摘要

我们比较了伴有或不伴有谷氨酸脱羧酶(GAD)抗体的糖基化异常患者在参加 OUTCOME 减少的初始甘精胰岛素干预(ORIGIN)试验中的心血管和其他结局。在 12537 名参与者中,8162 名在基线时测量了抗 GAD,267 名抗 GAD 阳性。通过检验治疗效果和抗 GAD 状态的相互作用,比较了甘精胰岛素与标准治疗的效果和 n-3 脂肪酸补充剂与安慰剂的效果。在基线时没有既往糖尿病的参与者中,评估了甘精胰岛素对新发糖尿病的影响。抗 GAD 阳性和抗 GAD 阴性患者的总体结局发生率没有差异。抗 GAD 阳性的参与者随机分配到甘精胰岛素或标准治疗,心血管死亡、非致死性心肌梗死或非致死性卒中的复合发生率无差异,风险比(HR)(95%置信区间[CI])为 0.80(0.44-1.44),抗 GAD 阴性的参与者 HR 为 1.07(0.96-1.20)(P 交互=0.20)。

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