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每日两次艾塞那肽、每周一次艾塞那肽或胰岛素对2型糖尿病且基线糖化血红蛋白≥10.0%患者的影响:两项汇总分析,纳入20项随机对照试验。

Effects of exenatide twice daily, exenatide once weekly or insulin in patients with type 2 diabetes and baseline HbA1c ≥10.0%: Two pooled analyses including 20 randomised controlled trials.

作者信息

Busch Robert S, Ruggles James, Han Jenny, Hardy Elise

机构信息

Albany Medical Center Community Division, The Endocrine Group, Albany, NY, USA.

Medical Affairs, AstraZeneca, Fort Washington, PA, USA.

出版信息

Int J Clin Pract. 2017 Dec;71(12). doi: 10.1111/ijcp.13029. Epub 2017 Oct 17.

Abstract

AIMS

Patients with advanced type 2 diabetes (T2D) and high glycated haemoglobin (HbA1c) values can be difficult to treat because of their severe metabolic disease. This pooled analysis examined the treatment effects of exenatide twice daily (BID), exenatide once weekly (QW) and insulin in patients with high baseline HbA1c (≥10.0%).

METHODS

This post hoc analysis used pooled data from 12 and 8 randomised controlled trials of exenatide BID and exenatide QW, respectively. Patients with T2D who completed at least 24 weeks of treatment with exenatide BID, exenatide QW or insulin (insulin glargine, insulin detemir or insulin aspart) were categorised by baseline HbA1c. Patients with HbA1c ≥10.0% were included in the analysis.

RESULTS

Both exenatide and insulin reduced HbA1c (mean ± SE reduction: -2.0% ± 0.2% [exenatide] and -2.1% ± 0.2% [insulin] in the exenatide BID studies, and -2.6% ± 0.1% [exenatide] and -2.1% ± 0.2% [insulin] in the exenatide QW studies; all P < .001). Body weight decreased with exenatide and increased with insulin. Systolic blood pressure decreased with exenatide QW. Insulin dose increased over the course of treatment. The most common adverse events with exenatide were gastrointestinal. Insulin was associated with some hypoglycaemia risk. Hypoglycaemia events occurred infrequently with exenatide when given without sulphonylureas.

CONCLUSIONS

For patients with high HbA1c, treatment with exenatide or insulin both improved glycaemic control. Given the associated weight loss and low risk of hypoglycaemia, exenatide may be a suitable alternative to treatment with insulin in certain patients with T2D and high HbA1c.

摘要

目的

晚期2型糖尿病(T2D)且糖化血红蛋白(HbA1c)值高的患者由于其严重的代谢疾病可能难以治疗。这项汇总分析研究了每日两次(BID)艾塞那肽、每周一次(QW)艾塞那肽和胰岛素对基线HbA1c高(≥10.0%)的患者的治疗效果。

方法

这项事后分析分别使用了来自12项和8项每日两次艾塞那肽和每周一次艾塞那肽随机对照试验的汇总数据。完成至少24周每日两次艾塞那肽、每周一次艾塞那肽或胰岛素(甘精胰岛素、地特胰岛素或门冬胰岛素)治疗的T2D患者按基线HbA1c进行分类。HbA1c≥10.0%的患者纳入分析。

结果

在每日两次艾塞那肽研究中,艾塞那肽和胰岛素均降低了HbA1c(平均±标准误降低:[艾塞那肽]-2.0%±0.2%,[胰岛素]-2.1%±0.2%;在每周一次艾塞那肽研究中,[艾塞那肽]-2.6%±0.1%,[胰岛素]-2.1%±0.2%;所有P<0.001)。体重随艾塞那肽降低而随胰岛素升高。收缩压随每周一次艾塞那肽降低。胰岛素剂量在治疗过程中增加。艾塞那肽最常见的不良事件是胃肠道反应。胰岛素与一些低血糖风险相关。不与磺脲类药物联用时,艾塞那肽很少发生低血糖事件。

结论

对于HbA1c高的患者,艾塞那肽或胰岛素治疗均改善了血糖控制。鉴于其伴随的体重减轻和低血糖风险低,在某些T2D且HbA1c高的患者中,艾塞那肽可能是胰岛素治疗的合适替代方案。

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