Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, WA 98195, USA.
Pharmacotherapy. 2009 Nov;29(11):1280-8. doi: 10.1592/phco.29.11.1280.
To project and compare long-term outcomes of morbidity and mortality, and costs of complications of type 2 diabetes mellitus from a randomized controlled trial of patients receiving liraglutide versus glimepiride monotherapy.
Mathematic simulation using the validated Center for Outcomes Research (CORE) Diabetes Model, calibrated to baseline patient characteristics from a short-term, randomized, controlled trial of liraglutide and glimepiride monotherapies (Liraglutide Effect and Action in Diabetes [LEAD]-3 trial) and using data from long-term outcomes studies.
Simulated routine clinical practice.
Seven hundred forty-six patients with type 2 diabetes who participated in the LEAD-3 trial, and three hypothetical cohorts of 5000 patients each that were based on the baseline characteristics of the patients in the LEAD-3 trial. The patients in the LEAD-3 trial were randomly assigned to monotherapy with liraglutide 1.2 mg/day (251 patients), liraglutide 1.8 mg/day (247 patients), or glimepiride 8 mg/day (248 patients).
The impact of the three treatments for type 2 diabetes on survival and cumulative incidence of cardiovascular, ocular, or renal events and costs were estimated at three time periods: 10, 20, and 30 years. Simulations predicted improved survival for liraglutide 1.8 and 1.2 mg at all three time points compared with glimepiride. Survival benefits were greatest after 30 years of follow-up: 16.5%, 13.6%, and 7.3%, respectively. The frequency of nonfatal renal and ocular events was lower for both liraglutide doses than for glimepiride. The rate of neuropathies leading to first or recurrent amputation was higher for glimepiride compared with both liraglutide doses. The average cumulative cost/patient was higher for glimepiride compared with liraglutide 1.2 mg and liraglutide 1.8 mg.
With use of the CORE Diabetes Model and data from the LEAD-3 trial, long-term projected survival, diabetes complications, and costs favored liraglutide 1.2- and 1.8-mg monotherapies compared with glimepiride in the treatment of type 2 diabetes.
通过对接受利拉鲁肽与格列美脲单药治疗的 2 型糖尿病患者进行随机对照试验,预测并比较长期发病率和死亡率以及并发症相关成本的差异。
利用经过验证的 CORE 糖尿病模型进行数学模拟,该模型根据短期随机对照试验(Liraglutide Effect and Action in Diabetes [LEAD]-3 试验)中利拉鲁肽和格列美脲单药治疗的基线患者特征进行校准,并使用长期结局研究的数据。
模拟常规临床实践。
746 例参与 LEAD-3 试验的 2 型糖尿病患者,以及三个基于 LEAD-3 试验中患者基线特征的、各 5000 例的假设队列。LEAD-3 试验中的患者被随机分配接受利拉鲁肽 1.2mg/天(251 例)、利拉鲁肽 1.8mg/天(247 例)或格列美脲 8mg/天(248 例)的单药治疗。
在三个时间段(10 年、20 年和 30 年),评估三种 2 型糖尿病治疗方法对生存和心血管、眼部或肾脏事件累积发生率及成本的影响。模拟预测利拉鲁肽 1.8mg 和 1.2mg 与格列美脲相比,所有三个时间点的生存都有改善。随访 30 年后,生存获益最大:分别为 16.5%、13.6%和 7.3%。两种利拉鲁肽剂量的非致命性肾脏和眼部事件频率均低于格列美脲。与两种利拉鲁肽剂量相比,格列美脲导致首次或复发截肢的神经病变发生率更高。与格列美脲相比,每位患者的平均累积成本更高。
使用 CORE 糖尿病模型和 LEAD-3 试验数据,长期预测生存、糖尿病并发症和成本均表明,与格列美脲相比,利拉鲁肽 1.2mg 和 1.8mg 单药治疗 2 型糖尿病更具优势。