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目的预测利拉鲁肽联用二甲双胍治疗2型糖尿病的长期健康结果。方法临床数据来源于国际多中心随机对照双盲临床试验NCT00614120,入组对象为来自中国、印度和韩国的2型糖尿病患者。选取利拉鲁肽1.2 mg·d~(-1)组(n=233)、利拉鲁肽1.8 mg·d~(-1)组(n=234)和格列美脲4.0 mg·d~(-1)组(n=231)的患者作为研究对象,每组患者均联用二甲双胍1.5～2.0 g·d~(-1),3组完成试验分别为187例、175例和215例。应用CORE糖尿病模型,输入16 wk临床试验前后患者机体参数改变值,模拟患者终身(30年)治疗健康结果。结果与格列美脲4.0 mg·d~(-1)组相比,利拉鲁肽1.2 mg·d~(-1)组患者背景型视网膜病变、终末期肾病、首次足溃疡和充血性心力衰竭死亡的累积发病率分别降低0.195%、0.086%、0.020%和0.528%,存活率增加了0.32%,预期寿命增加0.018年,质量调整生命年增加0.11年;利拉鲁肽1.8 mg·d~(-1)组以上4种并发症的累积发病率分别降低0.607%、0.116%、0.337%和0.626%,存活率增加了0.42%,预期寿命增加0.051年,质量调整生命年增加0.108年。敏感度分析结果显示,当模拟时间跨度分别设为10年、20年、35年,贴现率分别设置为0和5%时,与格列美脲4.0 mg·d~(-1)组的模拟结果相比,利拉鲁肽1.2 mg·d~(-1)组和1.8 mg·d~(-1)组均获得较长的存活率、预期寿命和质量调整生命年。结论与格列美脲联用二甲双胍相比,利拉鲁肽联用二甲双胍能够延缓并减少2型糖尿病患者并发症的发生,增加存活率、预期寿命与质量调整生命年。
Objective To predict the long-term health outcomes of liraglutide plus metformin in type 2 diabetes mellitus. Methods The clinical data were collected from the international multicenter randomized controlled double-blind clinical trial NCT00614120 and enrolled patients with type 2 diabetes from China, India and South Korea. Liraglutide 1.2 mg · d -1 (n = 233), liraglutide 1.8 mg · d -1 (n = 234) and glimepiride 4.0 mg · d ~ (-1) (-1) group (n = 231). The patients in each group were treated with metformin 1.5-2.0 g · d -1. The three groups were 187, 175 and 215 respectively. The CORE diabetes model was used to change the patient’s body parameters before and after the 16-week clinical trial to simulate the lifelong (30-year) treatment of health outcomes. Results Compared with glipizide 4.0 mg · d ~ (-1) group, liraglutide 1.2 mg · d ~ (-1) group had a background retinopathy, end-stage renal disease, first foot ulcer and congestive heart failure The cumulative incidence of death caused by death decreased by 0.195%, 0.086%, 0.020% and 0.528% respectively, the survival rate increased by 0.32% and the life expectancy increased by 0.18 years, the quality adjusted life years increased by 0.1 years; liraglutide 1.8 mg · d ~ (-1) group, the cumulative incidence of the four complications were reduced by 0.607%, 0.116%, 0.337% and 0.626% respectively, the survival rate increased by 0.42% and the life expectancy increased by 0. 051, the mass adjusted life year increased by 0.108 years. Sensitivity analysis showed that when the simulation time span was 10 years, 20 years and 35 years respectively, the discount rates were set to 0 and 5%, respectively, and glimepiride 4.0 mg · d -1 group simulation Compared with the results, liraglutide 1.2 mg · d -1 group and 1.8 mg · d -1 group were longer survival rate, life expectancy and quality of life-years. Conclusion Compared with the combination of glimepiride and metformin, liraglutide combined with metformin can delay and reduce the incidence of type 2 diabetes complications, increase survival, life expectancy and quality of life-years.