Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Diabetes Ther. 2015 Mar;6(1):61-74. doi: 10.1007/s13300-015-0103-5. Epub 2015 Mar 6.
Metformin is the first-line therapy for most patients with type 2 diabetes, but the majority require treatment intensification at some stage due to the progressive nature of the disease. The 1860-LIRA-DPP-4 trial showed that liraglutide exhibited greater improvements compared with sitagliptin in glycated hemoglobin and body mass index in patients with type 2 diabetes inadequately controlled on metformin monotherapy. As a follow-up to a previously published cost-effectiveness analysis of 1.2 mg liraglutide versus sitagliptin in Spain, the aim of this analysis was to compare long-term projections of the clinical and cost implications associated with 1.8 mg liraglutide and sitagliptin.
For the modeling analysis, 52-week treatment effect data (as opposed to 26-week data in the previous analysis) were taken from the 1860-LIRA-DPP-4 trial, for adults with type 2 diabetes receiving 1.8 mg liraglutide or 100 mg sitagliptin daily in addition to metformin. Long-term (patient lifetime) projections of clinical outcomes and direct costs (2012 EUR) were made using a published and validated model of type 2 diabetes, with modeling assumptions as per the 1.2 mg liraglutide analysis.
Liraglutide was associated with increased life expectancy (14.24 versus 13.87 years) and quality-adjusted life expectancy [9.24 versus 8.84 quality-adjusted life years (QALYs)] over sitagliptin. Improved clinical outcomes were attributable to the improvement in glycemic control, leading to a reduced incidence of diabetes-related complications, including renal disease, cardiovascular disease, ophthalmic and diabetic foot complications. Liraglutide was associated with increased direct costs (EUR 56,628 versus EUR 52,450), driven by increased pharmacy costs. Based on these estimates, liraglutide was associated with an incremental cost-effectiveness ratio of EUR 10,436 per QALY gained versus sitagliptin.
A previous analysis has suggested that 1.2 mg liraglutide is cost-effective from a healthcare payer perspective in Spain, and the present analysis suggests that the 1.8 mg dose is also likely to be cost-effective.
二甲双胍是大多数 2 型糖尿病患者的一线治疗药物，但由于疾病的进展性，大多数患者在某个阶段需要加强治疗。1860-LIRA-DPP-4 试验表明，在二甲双胍单药治疗控制不佳的 2 型糖尿病患者中，利拉鲁肽在糖化血红蛋白和体重指数方面的改善优于西他列汀。作为之前在西班牙发表的关于 1.2mg 利拉鲁肽与西他列汀的成本效益分析的后续研究，本分析旨在比较与 1.8mg 利拉鲁肽和西他列汀相关的临床和成本影响的长期预测。
对于建模分析，从 1860-LIRA-DPP-4 试验中采用 52 周的治疗效果数据（而不是之前分析中的 26 周数据），用于接受 1.8mg 利拉鲁肽或 100mg 西他列汀每天联合二甲双胍治疗的 2 型糖尿病成人患者。使用已发表和验证的 2 型糖尿病模型，根据 1.2mg 利拉鲁肽分析中的建模假设，对临床结果和直接成本（2012 欧元）进行长期（患者终生）预测。
与西他列汀相比，利拉鲁肽可使预期寿命延长（14.24 年比 13.87 年），并使质量调整预期寿命延长[9.24 年比 8.84 年质量调整生命年（QALY）]。临床结果的改善归因于血糖控制的改善，从而降低了糖尿病相关并发症的发生率，包括肾病、心血管疾病、眼科和糖尿病足并发症。利拉鲁肽导致直接成本增加（EUR56628 比 EUR52450），这主要是由于药房成本增加所致。根据这些估计，与西他列汀相比，利拉鲁肽每获得一个质量调整生命年的增量成本效益比为 EUR10436。
先前的分析表明，从西班牙医疗保健支付者的角度来看，1.2mg 利拉鲁肽具有成本效益，本分析表明，1.8mg 剂量也可能具有成本效益。
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