Diabetes Obes Metab:根据基线糖化血红蛋白(HbA1c)亚组扩大度拉糖肽剂量范围的血糖疗效

2021-11-09 从医路漫漫 MedSci原创

在2型糖尿病中,随着时间的推移,维持血糖水平稳定通常需要通过现用药物加量或开始新的治疗方案(增加或换用)来加强治疗。

背景:在2型糖尿病中,随着时间的推移,维持血糖水平稳定通常需要通过现用药物加量或开始新的治疗方案(增加或换用)来加强治疗。许多患者推荐使用胰高血糖素样肽-1受体激动剂(GLP-1RAs)来降低糖化血红蛋白(HbA1c)和带来心血管益处,而不会增加低血糖或体重增加的风险。而AWARD-11试验证明,在二甲双胍控制不充分的2型糖尿病患者中,度拉糖肽3.0和4.5 mg与度拉糖肽1.5 mg相比安全性和有效性。

方法:这是一项随机、3期、双盲、多中心、平行对照试验。患者开始时每周注射一次度拉糖肽0.75mg,持续4周,然后每4周逐步增加剂量,达到1.5、3.0或4.5mg的随机剂量(图S1)。纳入标准包括年龄≥18岁,糖化血红蛋白≥58mmolmol(7.5%)和≤97mmolmol(11.0%),体重指数≥25 kg/m2,每日≥1500 mg二甲双胍治疗(表S2)。

主要疗效指标(HbA1c较基线的变化)和次要疗效指标(HbA1c <53 mmol/mol[7.0%]的患者比例、空腹血糖水平与基线相比的变化、以及体重较基线的变化)。对于目前的探索性分析,在以下由基线HbA1c定义的降低血糖控制的亚组中,评估了HbA1c较基线的变化以及在36和52周时达到HbA1c <53 mmol/ mol的患者比例:<8%;8%至< 9%;9% ~ < 10%;和≥10%。

安全性评估:包括常见胃肠道(GI)反应(恶心、呕吐和腹泻)的发生率和低血糖发作(临床显著的低血糖[2级,即血糖水平< 3.0 mmol/L或54 mg/dl];严重低血糖(3级,即精神和/或身体机能发生改变,需要他人帮助才能恢复,持续时间长达52周)。

结果:36周时,所有基线HbA1c亚组的HbA1c平均降低(HbA1c变化范围:1.5 mg:-1.0%~-2.2%;3.0 mg:-1.2%~-2.5%;4.5 mg:-1.2%~-3.2%)。无论基线糖化血红蛋白(HbA1c)如何,随机服用3.0mg HbA1c或4.5mg HbA1c的患者在36周时糖化血红蛋白(HbA1c)<7%的占比更高;基线HbA1c越高,比例差异越大(P-交互作用=0.096)。52周时,血糖改善和糖化血红蛋白(HbA1c)<7%的比例与36周相似。HbA1c亚组间低血糖和胃肠道不良反应相似。

图 糖化血红蛋白(HbA1c)在36周和52周时从基线和达到HbA1c目标的患者比例发生变化。

N=基线值未缺失且至少有一个反应变量基线后值未缺失的患者。分析包括无其他降糖药物治疗的数据。A,糖化血红蛋白从基线到36周的变化(主要时间点;重复测量混合模型[MMRM]。B, 36周时HbA1c <53 mmol/mol的患者比例,纵向logistic回归。C,糖化血红蛋白从基线到52周的变化,MMRM。D, 52周时糖化血红蛋白<53 mmol/mol的患者比例,纵向logistic回归。p值为36周和52周时亚组和治疗的交互作用,使用显著性水平0.10进行评估,未经调整。美国糖尿病协会目前的2型糖尿病治疗指南建议糖化血红蛋白<53 mmol/mol(7%)。BL,基线;DU,度拉糖肽;ETD,估计治疗差异4.5 mg与1.5 mg;HbA1c:糖化血红蛋白;LS,最小二乘法

表 度拉糖肽治疗组和基线糖化血红蛋白亚组在52周内胃肠道和低血糖事件的发生率

结论:在基线糖化血红蛋白(HbA1c)亚组中,随着度拉糖肽剂量从1.5mg升至3.0mg或4.5mg时,血糖控制得到改善(<8%;8.0%-<9.0%;9.0%-<10%;≥为10%)。

原文出处:

Frias JP,  Bonora E,  Cox DA,et al.Glycemic Efficacy of an Expanded Dose Range of Dulaglutide by Baseline HbA1c Subgroups: Post hoc Analysis of AWARD-11.Diabetes Obes Metab 2021 Aug 31

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    2022-08-16 一闲
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    2022-03-03 guojianrong
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    2022-03-04 Smile2680
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