University of Parma and Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA, USA.
Diabetes Metab Res Rev. 2017 Sep;33(6). doi: 10.1002/dmrr.2897. Epub 2017 Jun 20.
The effect of lixisenatide-a prandial once-daily glucagon-like peptide-1 receptor agonist-on glycaemic control in patients with inadequately controlled type 2 diabetes mellitus (T2DM), stratified by baseline β-cell function, was assessed.
The 24-week GetGoal-M, -P and -S trials evaluated the efficacy and safety of lixisenatide in combination with oral antidiabetic agents. This post hoc analysis used data from patients receiving lixisenatide in these trials, divided into matched cohorts by propensity scoring, and stratified according to baseline homeostasis model assessment of β-cell function (HOMA-β) index levels, high HOMA-β: > median HOMA-β (28.49%); low HOMA-β: ≤ median.
The matched "low" and "high" HOMA-β index cohorts (N = 546 patients) had comparable baseline parameters. Mean change from baseline in glycated haemoglobin (HbA ) was -0.85% and -0.94% for low and high HOMA-β cohorts, respectively (P = .2607). Reductions from baseline in fasting plasma glucose (FPG; -0.77 vs -1.04 mmol/L; P = .1496) and postprandial plasma glucose (PPG; -5.82 vs -5.61 mmol/L; P = .7511) were similar in the low versus high HOMA-β index cohorts. Reduction in body weight was significantly greater in the low versus high HOMA-β index cohort (-2.06 vs -1.13 kg, respectively; P = .0006).
In patients with T2DM, lixisenatide was associated with reduction in HbA and improvements in both FPG and PPG, regardless of β-cell function, indicating that lixisenatide is effective in reducing hyperglycaemia, even in patients with more advanced stages of T2DM and poor residual β-cell function.
本研究评估了基线β细胞功能分层的情况下,每日一次胰高血糖素样肽-1 受体激动剂利西那肽对血糖控制不佳的 2 型糖尿病(T2DM)患者的疗效。
GetGoal-M、-P 和 -S 试验为期 24 周,评估了利西那肽联合口服降糖药的疗效和安全性。本事后分析使用了这些试验中接受利西那肽治疗的患者的数据,通过倾向评分匹配分为匹配队列,并根据基线稳态模型评估β细胞功能(HOMA-β)指数水平分层,高 HOMA-β:>中位数 HOMA-β(28.49%);低 HOMA-β:≤中位数。
匹配的“低”和“高”HOMA-β指数队列(N=546 例患者)具有可比的基线参数。低和高 HOMA-β 队列的糖化血红蛋白(HbA)自基线的平均变化分别为-0.85%和-0.94%(P=0.2607)。空腹血糖(FPG)自基线的降低(-0.77 与-1.04mmol/L;P=0.1496)和餐后血糖(PPG)自基线的降低(-5.82 与-5.61mmol/L;P=0.7511)在低 HOMA-β 指数与高 HOMA-β 指数队列之间相似。低 HOMA-β 指数队列的体重减轻明显大于高 HOMA-β 指数队列(分别为-2.06 与-1.13kg;P=0.0006)。
在 T2DM 患者中,无论β细胞功能如何,利西那肽均可降低 HbA,并改善 FPG 和 PPG,表明利西那肽可有效降低高血糖,即使在 T2DM 更晚期且β细胞功能较差的患者中也是如此。