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2 型糖尿病缓解:糖尿病缓解临床试验(DiRECT)/Counterweight-Plus 体重管理计划的 2 年试验内和终身效价成本效益。

Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.

机构信息

Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.

Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.

出版信息

Diabetologia. 2020 Oct;63(10):2112-2122. doi: 10.1007/s00125-020-05224-2. Epub 2020 Aug 10.

DOI:10.1007/s00125-020-05224-2
PMID:32776237
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7476973/
Abstract

AIMS/HYPOTHESIS: Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).

METHODS

Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.

RESULTS

Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.

CONCLUSIONS/INTERPRETATION: Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.

TRIAL REGISTRATION

ISRCTN03267836 Graphical abstract.

摘要

目的/假设:全球范围内,约有 10%的医疗保健预算用于治疗糖尿病及其并发症,而且由于人口老龄化和二线药物更加昂贵,预算在全球范围内呈上升趋势。该研究的目的是评估体重管理计划的试验内和终生成本效益,该计划在糖尿病缓解临床试验(DIRECT)的第 1 年实现了 46%的 2 型糖尿病缓解,第 2 年实现了 36%的缓解。

方法

试验内分析评估了 Counterweight-Plus 干预措施在 DIRECT 中的成本(包括培训、计划材料、医生预约和低能量饮食),以及降糖和降压药物以及所有常规医疗保健接触的成本。根据预计的缓解持续时间,按照 2 年 DIRECT 中观察到的持续复发率和相应的预期寿命、生活质量和医疗保健成本,估计了每质量调整生命年(QALY)的终生成本。

结果

干预组和对照组的 2 年平均总医疗保健成本分别为 3036 英镑和 2420 英镑:增量成本为 616 英镑(95%CI-45 英镑,1269 英镑)。干预成本(1411 英镑;95%CI1308 英镑,1511 英镑)部分被其他医疗保健成本的降低所抵消(796 英镑;95%CI150 英镑,1465 英镑),包括口服降糖药物减少 231 英镑(95%CI148 英镑,314 英镑)。2 年的净缓解率为 32.3%(95%CI23.5%,40.3%),每实现一次缓解的成本为 1907 英镑(较低的 95%CI:干预主导;较高的 95%CI:4212 英镑)。在终身范围内,该干预措施预计在 DIRECT 人群中可实现平均 0.06(95%CI0.04,0.09)的 QALY 增益,每个参与者的总终生成本节约为 1337 英镑(95%CI674 英镑,2081 英镑),干预措施在 6 年内开始具有成本效益。

结论/解释:将由于糖尿病及其并发症缓解而产生的终生医疗保健成本节约纳入考虑范围,与标准护理相比,DIRECT 干预措施预计在 2 型糖尿病成人中不仅更有效(QALY 增益),而且更具成本效益。这个结论似乎在各种不太有利的模型情景下都是稳健的,为资源可以有效地转移以支持通过 DIRECT 干预实现缓解提供了强有力的证据。

试验注册

ISRCTN03267836 图表摘要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/77aa471dbbbc/125_2020_5224_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/851caabd7af8/125_2020_5224_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/41ee9d2c5c96/125_2020_5224_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/77aa471dbbbc/125_2020_5224_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/851caabd7af8/125_2020_5224_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/41ee9d2c5c96/125_2020_5224_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f57/7476973/77aa471dbbbc/125_2020_5224_Fig2_HTML.jpg

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