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为老年2型糖尿病患者个体化制定治疗目标:24周随机对照INTERVAL研究中影响临床决策的因素

Individualizing treatment targets for elderly patients with type 2 diabetes: factors influencing clinical decision making in the 24-week, randomized INTERVAL study.

作者信息

Strain W David, Agarwal Abhijit S, Paldánius Päivi M

机构信息

Diabetes and Vascular Research Centre, University of Exeter Medical School, Exeter EX2 5AX, UK.

Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.

出版信息

Aging (Albany NY). 2017 Mar 5;9(3):769-777. doi: 10.18632/aging.101188.

Abstract

We tested the feasibility of setting individualized glycemic goals and factors influencing targets set in a clinical trial in elderly patients with type 2 diabetes.A 24-week, randomized, double-blind, placebo-controlled study was conducted in 45 outpatient centers in seven European countries. 278 drug-naïve or inadequately controlled (mean HbA1c 7.9%) patients with type 2 diabetes aged ≥70 years with HbA1c levels ≥7.0% and ≤10.0% were enrolled. Investigator-defined individualized HbA1c targets and the impact of baseline characteristics on individualized treatment targets was evaluated.The average individualized HbA1c target was set at 7.0%. HbA1c at baseline predicted a target setting such that higher the HbA1c, more aggressive was the target (P<0.001). Men were more likely to be set aggressive targets than women (P=0.026). Frailty status of patients showed a trend towards significance (P=0.068), whereas diabetes duration, age, or polypharmacy did not. There was heterogeneity between countries regarding how baseline factors were viewed.Despite training and guidance to individualize HbA1c goals, targets were still set in line with conventional values. A strong influence of country-specific guidelines on target setting was observed; confirming the importance of further education to implement new international guidelines in older adults.

摘要

我们在一项针对老年2型糖尿病患者的临床试验中,测试了设定个体化血糖目标的可行性以及影响目标设定的因素。在欧洲七个国家的45个门诊中心进行了一项为期24周的随机、双盲、安慰剂对照研究。纳入了278例年龄≥70岁、HbA1c水平≥7.0%且≤10.0%的2型糖尿病初治或控制不佳(平均HbA1c 7.9%)患者。评估了研究者定义的个体化HbA1c目标以及基线特征对个体化治疗目标的影响。平均个体化HbA1c目标设定为7.0%。基线时的HbA1c可预测目标设定,即HbA1c越高,目标越激进(P<0.001)。男性比女性更有可能被设定激进目标(P=0.026)。患者的衰弱状态显示出显著趋势(P=0.068),而糖尿病病程、年龄或联合用药情况则不然。各国在如何看待基线因素方面存在异质性。尽管对个体化HbA1c目标进行了培训和指导,但目标设定仍符合传统值。观察到特定国家指南对目标设定有很大影响;这证实了在老年人中进一步开展教育以实施新的国际指南的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c86/5391230/8ac768e58b57/aging-09-769-g001.jpg

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