Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada.
Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
Effective type 2 diabetes management requires a multifactorial approach extending beyond glycaemic control. Clinical practice guidelines suggest targets for HbA1c, blood pressure and lipids, and emphasize weight reduction and avoiding hypoglycaemia. The phase 3 clinical trial programme for liraglutide, a human glucagon-like peptide 1 analogue, showed significant improvements in HbA1c and weight with a low risk of hypoglycaemia compared to other diabetes therapies. In this context, we performed a meta-analysis of data from these trials evaluating the proportion of patients achieving a clinically relevant composite measure of diabetes control consisting of an HbA1c <7% without weight gain or hypoglycaemia.
A prespecified meta-analysis was performed on 26-week patient-level data from seven trials (N = 4625) evaluating liraglutide with commonly used therapies for type 2 diabetes: glimepiride, rosiglitazone, glargine, exenatide, sitagliptin or placebo, adjusting for baseline HbA1c and weight, for a composite outcome of HbA1c <7.0%, no weight gain and no hypoglycaemic events.
At 26 weeks, 40% of the liraglutide 1.8 mg group, 32% of the liraglutide 1.2 mg group and 6-25% of comparators (6% rosiglitazone, 8% glimepiride, 15% glargine, 25% exenatide, 11% sitagliptin, 8% placebo) achieved this composite outcome. Odds ratios favoured liraglutide 1.8 mg by 2.0- to 10.5-fold over comparators.
As assessed by the composite outcome of HbA1c <7%, no hypoglycaemia and no weight gain, liraglutide was clearly superior to the other commonly used therapies. However, the long-term clinical impact of this observation remains to be shown.
有效的 2 型糖尿病管理需要一种多因素方法，不仅要控制血糖。临床实践指南建议针对 HbA1c、血压和血脂设定目标，并强调减轻体重和避免低血糖。利拉鲁肽是一种人胰高血糖素样肽 1 类似物的 3 期临床试验项目表明，与其他糖尿病治疗方法相比，利拉鲁肽在低血糖风险低的情况下，HbA1c 和体重有显著改善。在这种情况下，我们对这些试验的数据进行了荟萃分析，评估了达到 HbA1c<7%、体重无增加且无低血糖的临床相关糖尿病综合控制指标的患者比例。
对 7 项评估利拉鲁肽与常用于治疗 2 型糖尿病的药物（格列美脲、罗格列酮、甘精胰岛素、艾塞那肽、西他列汀或安慰剂）的 26 周患者水平数据进行了预设的荟萃分析（N=4625），调整了基线 HbA1c 和体重，用于 HbA1c<7.0%、体重无增加和无低血糖事件的复合结局。
在 26 周时，利拉鲁肽 1.8mg 组有 40%、利拉鲁肽 1.2mg 组有 32%、对照组（6%罗格列酮、8%格列美脲、15%甘精胰岛素、25%艾塞那肽、11%西他列汀、8%安慰剂）有 6-25%达到了这一综合结果。与对照组相比，利拉鲁肽 1.8mg 的优势比为 2.0-10.5 倍。
根据 HbA1c<7%、无低血糖和无体重增加的综合结果评估，利拉鲁肽明显优于其他常用疗法。然而，这种观察结果的长期临床影响仍有待证实。
