Brändle M, Erny-Albrecht K M, Goodall G, Spinas G A, Streit P, Valentine W J
Division of Endocrinology and Diabetes, Department of Internal Medicine, Kantonsspital St. Gallen, Switzerland.
Int J Clin Pharmacol Ther. 2009 Aug;47(8):501-15. doi: 10.5414/cpp47501.
To investigate the long-term clinical and economic outcomes associated with exenatide versus insulin glargine as "add-on" treatments to oral therapy in individuals with Type 2 diabetes inadequately controlled with combination oral agents in the Swiss setting.
A computer simulation model of diabetes was used to project complications, life expectancy, quality-adjusted life expectancy and direct medical costs over a 35-year time horizon. Cohort characteristics and treatment effect data were derived from a 26-week randomized clinical trial comparing exenatide and insulin glargine. Modeled treatment effects included reductions in glycosylated hemoglobin (HbA1c) by -0.99% and -1.07% and in body mass index (BMI) by -0.80 and +0.55 kg/m2 with exenatide and insulin glargine respectively. Changes in systolic blood pressure and serum lipid levels were also captured. Simulations incorporated published quality of life utilities and Swiss costs from 2006. Extensive sensitivity analyses were conducted to assess the robustness of projected outcomes. Future clinical and economic outcomes were discounted at 2.5% per annum.
In the base-case analysis exenatide was associated with comparable life expectancy (11,549 years versus 11,468 years) and an improvement in quality-adjusted life expectancy of 0.43 quality-adjusted life years (QALYs) versus insulin glargine over a 35-year time horizon. Exenatide was associated with a reduced cumulative incidence of most diabetes-related complications including an absolute reduction in myocardial infarction by 0.28%. Assuming an annual treatment cost of CHF 2,797.74 for exenatide, direct costs increased by CHF 8,378 per patient over the 35-year time horizon compared to insulin glargine. The resultant incremental cost-effectiveness ratio was CHF 19,450 per QALY gained for exenatide versus insulin glargine.
Exenatide was associated with comparable life expectancy and an improvement in quality-adjusted life expectancy versus insulin glargine over a 35-year time horizon. Based on current standards exenatide would be a cost-effective treatment alternative to insulin glargine in Switzerland for Type 2 diabetes patients inadequately controlled on oral therapy.
在瑞士的背景下，研究与艾塞那肽相比，甘精胰岛素作为联合口服药物治疗控制不佳的2型糖尿病患者的“附加”治疗方法的长期临床和经济结果。
使用糖尿病计算机模拟模型预测35年时间范围内的并发症、预期寿命、质量调整预期寿命和直接医疗成本。队列特征和治疗效果数据来自一项比较艾塞那肽和甘精胰岛素的26周随机临床试验。模拟的治疗效果包括使用艾塞那肽和甘精胰岛素分别使糖化血红蛋白（HbA1c）降低-0.99%和-1.07%，体重指数（BMI）降低-0.80和+0.55kg/m2。还记录了收缩压和血脂水平的变化。模拟纳入了已发表的生活质量效用值和2006年的瑞士成本。进行了广泛的敏感性分析以评估预测结果的稳健性。未来的临床和经济结果按每年2.5%进行贴现。
在基础病例分析中，在35年的时间范围内，与甘精胰岛素相比，艾塞那肽的预期寿命相当（11549年对11468年），质量调整预期寿命提高了0.43个质量调整生命年（QALYs）。艾塞那肽与大多数糖尿病相关并发症的累积发生率降低相关，包括心肌梗死绝对发生率降低0.28%。假设艾塞那肽的年治疗成本为2797.74瑞士法郎，与甘精胰岛素相比，在35年的时间范围内每位患者的直接成本增加了8378瑞士法郎。与甘精胰岛素相比，艾塞那肽获得的增量成本效益比为每QALY 19450瑞士法郎。
在35年的时间范围内，与甘精胰岛素相比，艾塞那肽的预期寿命相当，质量调整预期寿命有所改善。根据当前标准，在瑞士，对于口服治疗控制不佳的2型糖尿病患者，艾塞那肽将是甘精胰岛素具有成本效益的替代治疗方法。
