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1型糖尿病患者血糖控制、体重及低血糖发生率变化的健康经济价值

The Health Economic Value of Changes in Glycaemic Control, Weight and Rates of Hypoglycaemia in Type 1 Diabetes Mellitus.

作者信息

McEwan Phil, Bennett Hayley, Fellows Jonathan, Priaulx Jennifer, Bergenheim Klas

机构信息

Health Economics and Outcomes Research Ltd., Mulberry Drive, Cardiff, United Kingdom.

Global Health Economics and Outcomes Research, AstraZeneca, London, United Kingdom.

出版信息

PLoS One. 2016 Sep 15;11(9):e0162441. doi: 10.1371/journal.pone.0162441. eCollection 2016.

Abstract

AIMS

Therapy-related consequences of treatment for type 1 diabetes mellitus (T1DM), such as weight gain and hypoglycaemia, act as a barrier to attaining optimal glycaemic control, indirectly influencing the incidence of vascular complications and associated morbidity and mortality. This study quantifies the individual and combined contribution of changes in hypoglycaemia frequency, weight and HbA1c to predicted quality-adjusted life-years (QALYs) within a T1DM population.

MATERIALS AND METHODS

We describe the Cardiff Type 1 Diabetes (CT1DM) Model, originally informed by the Diabetes Control and Complications Trial (DCCT) and updated with the Epidemiology of Diabetes Interventions and Complications (EDIC) study and Swedish National Diabetes Registry for microvascular and cardiovascular complications respectively. We report model validation results and the QALY impact of HbA1c, weight and hypoglycaemia changes.

RESULTS

Validation results demonstrated coefficients of determination for clinical endpoints of R2 = 0.863 (internal R2 = 0.999; external R2 = 0.823), costs R2 = 0.980 and QALYs R2 = 0.951. Achieving and maintaining a 1% HbA1c reduction was estimated to provide 0.61 additional discounted QALYs. Weight changes of ±1kg, ±2kg or ±3kg led to discounted QALY changes of ±0.03, ±0.07 and ±0.10 respectively, while modifying hypoglycaemia frequency by -10%, -20% or -30% resulted in changes of -0.05, -0.11 and -0.17. The differences in discounted costs, life-years and QALYs associated with HbA1c 6% versus 10% were -£19,037, 2.49 and 2.35 respectively.

CONCLUSIONS

Using a model updated with contemporary epidemiological data, this study presents an outcome-focused perspective to assessing the health economic consequences of differing levels of glycaemic control in T1DM with and without weight and hypoglycaemia effects.

摘要

目的

1型糖尿病(T1DM)治疗的相关后果,如体重增加和低血糖,是实现最佳血糖控制的障碍,间接影响血管并发症的发生率以及相关的发病率和死亡率。本研究量化了低血糖频率、体重和糖化血红蛋白(HbA1c)变化对T1DM人群预测的质量调整生命年(QALY)的个体及综合影响。

材料与方法

我们描述了加的夫1型糖尿病(CT1DM)模型,该模型最初基于糖尿病控制与并发症试验(DCCT)构建,并分别根据糖尿病干预与并发症流行病学(EDIC)研究以及瑞典国家糖尿病登记处关于微血管和心血管并发症的数据进行了更新。我们报告了模型验证结果以及HbA1c、体重和低血糖变化对QALY的影响。

结果

验证结果表明,临床终点的决定系数R2 = 0.863(内部R2 = 0.999;外部R2 = 0.823),成本R2 = 0.980,QALY R2 = 0.951。估计将HbA1c降低并维持1%可额外提供0.61个贴现QALY。体重变化±1kg、±2kg或±3kg分别导致贴现QALY变化±0.03、±0.07和±0.10,而将低血糖频率降低-10%、-20%或-30%则导致变化-0.05、-0.11和-0.17。与HbA1c 6%和10%相关的贴现成本、生命年和QALY的差异分别为-19,037英镑、2.49和2.35。

结论

本研究使用了根据当代流行病学数据更新的模型,从以结果为导向的角度评估了在有或无体重及低血糖影响的情况下,T1DM不同血糖控制水平的健康经济后果。

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