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基于西他列汀的治疗方案对欧洲2型糖尿病患者且二甲双胍单药治疗时糖化血红蛋白高于目标值的成本效益分析

Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy.

作者信息

Schwarz B, Gouveia M, Chen J, Nocea G, Jameson K, Cook J, Krishnarajah G, Alemao E, Yin D, Sintonen H

机构信息

Center of Public Health of the Medical University of Vienna (Austria), Karl Landsteiner Institute of Health Economics, Vienna, Austria. bernhard.schwarz@

出版信息

Diabetes Obes Metab. 2008 Jun;10 Suppl 1:43-55. doi: 10.1111/j.1463-1326.2008.00886.x.

Abstract

OBJECTIVE

Sitagliptin is a novel oral incretin enhancer that acts by inhibiting the dipeptidyl peptidase 4 enzyme and is indicated in Europe as a treatment adjunct to metformin (MF), sulphonylurea (SU), MF plus SU and diet and exercise, in the management of type 2 diabetes mellitus. The objective of the current analysis was to evaluate the cost-effectiveness of adding sitagliptin to the regimens of patients with haemoglobin A1c (HbA1C) above the International Diabetes Federation goal (6.5%) while on MF in six European countries: Austria, Finland, Portugal, Scotland (United Kingdom), Spain and Sweden.

METHODS

A discrete event simulation model, which employed the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model risk equations for predicting risks of diabetes-related complication, was used. Lifetime costs and benefits were projected for alternative treatment strategies of adding sitagliptin, compared with adding rosiglitazone or a SU to MF in patients not at HbA1C goal on MF monotherapy. Changes in HbA1C as well as side effects associated with these different treatment strategies were based on clinical trial data. Mean baseline values from local epidemiologic studies involving patients with type 2 diabetes not at HbA1C goal on MF monotherapy were included in the current analysis. Costs of medications, side effects and direct costs of diabetes-related complications were based on country-specific data. UKPDS-based disutility weights associated with diabetes complications were incorporated. Disutilities associated with medication side effects were based on published data. All future costs and benefits were discounted according to local guidelines on cost-effectiveness analysis. One-way sensitivity analyses were conducted by varying key input parameters.

FINDINGS

The discounted incremental cost-effectiveness ratios (ICER) associated with the addition of sitagliptin to MF, compared with adding rosiglitazone, in the different countries analysed ranged from treatment with sitagliptin being dominant (cost saving with improved health outcome) to its being cost-effective [4,766 euros per quality-adjusted life year (QALY)]. Treatment with sitagliptin added to MF was cost-effective compared with adding a SU, with discounted ICER values ranging from 5949 euros/QALY to 20,350 euros/QALY across countries. Sensitivity analyses showed that these results were robust to changes in input parameters, including clinical efficacy, costs and utility weights for both diabetes-related complications and hypoglycaemia.

CONCLUSIONS

Compared with adding rosiglitazone or a SU to MF, adding sitagliptin to MF is projected to be either cost saving or cost-effective for patients with type 2 diabetes who are not at HbA1C goal on MF.

摘要

目的

西格列汀是一种新型口服肠促胰岛素增强剂,通过抑制二肽基肽酶4发挥作用,在欧洲被用作二甲双胍(MF)、磺脲类药物(SU)、MF加SU以及饮食和运动治疗2型糖尿病的辅助治疗药物。本分析的目的是评估在奥地利、芬兰、葡萄牙、苏格兰(英国)、西班牙和瑞典这六个欧洲国家,对于糖化血红蛋白(HbA1C)高于国际糖尿病联盟目标(6.5%)且正在接受MF治疗的患者,在其治疗方案中添加西格列汀的成本效益。

方法

采用离散事件模拟模型,该模型运用英国前瞻性糖尿病研究(UKPDS)结局模型风险方程来预测糖尿病相关并发症的风险。对添加西格列汀的替代治疗策略的终生成本和效益进行了预测,并与在MF单药治疗未达HbA1C目标的患者中添加罗格列酮或SU进行比较。不同治疗策略的HbA1C变化以及与之相关的副作用均基于临床试验数据。当前分析纳入了来自当地流行病学研究的平均基线值,这些研究涉及MF单药治疗未达HbA1C目标的2型糖尿病患者。药物成本、副作用以及糖尿病相关并发症的直接成本均基于各国的具体数据。纳入了与糖尿病并发症相关的基于UKPDS的失用权重。与药物副作用相关的失用基于已发表的数据。所有未来成本和效益均根据当地成本效益分析指南进行贴现。通过改变关键输入参数进行单向敏感性分析。

结果

在不同国家的分析中,与添加罗格列酮相比,在MF治疗中添加西格列汀的贴现增量成本效益比(ICER)范围从添加西格列汀治疗占主导地位(成本节约且健康结局改善)到具有成本效益[每质量调整生命年(QALY)4766欧元]。与添加SU相比,在MF治疗中添加西格列汀具有成本效益,各国贴现ICER值范围从5949欧元/QALY到20350欧元/QALY。敏感性分析表明,这些结果对于包括糖尿病相关并发症和低血糖的临床疗效、成本和效用权重等输入参数的变化具有稳健性。

结论

对于MF治疗未达HbA1C目标的2型糖尿病患者,与在MF治疗中添加罗格列酮或SU相比,添加西格列汀预计具有成本节约或成本效益。

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