Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
Diabetes Obes Metab. 2020 Jan;22(1):107-115. doi: 10.1111/dom.13871. Epub 2019 Oct 7.
To evaluate the comparative efficacy and safety of lixisenatide combined with basal insulin (BI) vs intensive premix insulin (premix), BI plus prandial insulin with the main meal (basal-plus) or progressively covering all meals (basal-bolus) in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by BI, and the long-term cost-effectiveness of lixisenatide from a Chinese healthcare system perspective.
Randomized controlled trials (RCTs) published between 1998 and 2018 were systematically searched. The clinical efficacy and safety of each treatment were compared by network meta-analysis (NMA). The IQVIA CORE Diabetes Model was used to estimate the lifetime quality-adjusted life-years (QALYs) and direct medical costs of patients treated with different strategies.
Eight RCTs were finally included. Lixisenatide plus BI showed a similar reduction in HbA1c from baseline compared with premix, basal-plus and basal-bolus. There were significant differences in the change of body weight in favour of lixisenatide plus BI compared with the three insulin regimens. The risk of symptomatic hypoglycaemia of lixisenatide plus BI was significantly lower compared with premix and basal-bolus. Lixisenatide plus BI was cost-effective compared with premix, basal-plus and basal-bolus with incremental cost-effectiveness ratios of Chinese yuan (CNY) 87 219, 48 173 and 48 670 per QALY gained, respectively, under the threshold of three times the gross domestic product (GDP) per capita in China.
Lixisenatide plus BI shows a similar HbA1c reduction compared with insulin regimens, accompanied by lower risk of hypoglycaemia and greater body weight reduction. It is a cost-effective treatment alternative for patients with T2DM inadequately controlled by BI in China.
评估利西拉肽联合基础胰岛素（BI）与强化预混胰岛素（预混）、BI 联合主餐时餐时胰岛素（基础-餐时）或逐步覆盖所有餐时（基础-餐时）相比，在 BI 控制不佳的 2 型糖尿病（T2DM）患者中的疗效和安全性，以及从中国医疗保健系统角度评估利西拉肽的长期成本效益。
系统检索了 1998 年至 2018 年发表的随机对照试验（RCT）。通过网络荟萃分析（NMA）比较每种治疗的临床疗效和安全性。使用 IQVIA CORE 糖尿病模型估算不同治疗策略下患者的终生质量调整生命年（QALYs）和直接医疗费用。
最终纳入了 8 项 RCT。与预混、基础-餐时和基础-餐时相比，利西拉肽联合 BI 治疗可使 HbA1c 从基线水平相似降低。与三种胰岛素方案相比，利西拉肽联合 BI 治疗在体重变化方面有显著优势。与预混和基础-餐时相比，利西拉肽联合 BI 治疗发生症状性低血糖的风险显著降低。利西拉肽联合 BI 治疗比预混、基础-餐时和基础-餐时更具成本效益，其增量成本-效果比分别为人民币（CNY）87219、48173 和 48670 元/QALY，在中国人均国内生产总值（GDP）的三倍阈值内。
与胰岛素方案相比，利西拉肽联合 BI 治疗可使 HbA1c 水平相似降低，同时低血糖风险更低，体重减轻更明显。对于 BI 控制不佳的中国 T2DM 患者，利西拉肽联合 BI 是一种具有成本效益的治疗选择。
