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Impact of baseline characteristics and beta-cell function on the efficacy and safety of subcutaneous once-weekly semaglutide: A patient-level, pooled analysis of the SUSTAIN 1-5 trials.
Diabetes, Obesity and Metabolism ( IF 5.8 ) Pub Date : 2019-11-14 , DOI: 10.1111/dom.13896
Vanita R Aroda 1 , Matthew S Capehorn 2 , Louis Chaykin 3 , Juan P Frias 4 , Nanna L Lausvig 5 , Stanislava Macura 5 , Jörg Lüdemann 6 , Sten Madsbad 7 , Julio Rosenstock 8 , Omur Tabak 9 , Sayeh Tadayon 5 , Stephen C Bain 10
Affiliation  

AIM To evaluate the impact of relevant patient-level characteristics on the efficacy and safety of subcutaneous, once-weekly semaglutide in subjects with type 2 diabetes. MATERIALS AND METHODS Exploratory post hoc analyses of pooled SUSTAIN 1-5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA1c and body weight (BW), and the proportions of subjects achieving the composite endpoint (HbA1c < 7.0% [53 mmol/mol]), without weight gain or severe/blood glucose-confirmed symptomatic hypoglycaemia at week 30 with semaglutide (0.5/1.0 mg) across clinically relevant patient subgroups: baseline HbA1c (≤7.5%, >7.5%-8.0%, >8.0%-8.5%, >8.5%-9.0% and > 9.0%), background medications, diabetes duration and pancreatic beta-cell function. RESULTS Mean HbA1c (% point) reductions increased from lowest to highest HbA1c subgroups (-0.9%, -1.2%,-1.5%, -1.7% and -2.3% [effect of subgroup within treatment: P = 0.247] for semaglutide 0.5 mg, and -1.1%, -1.4%, -1.9%, -2.1% and -2.7% [P = 0.045] for semaglutide 1.0 mg), with mean HbA1c ranges at week 30 of 6.3%-7.3% and 6.1%-6.9%, respectively. The corresponding BW reductions generally decreased with increasing baseline HbA1c (-4.4, -3.9, -3.9, -3.3 and -2.9 kg [P = 0.004], and -6.4, -5.9, -5.2, -4.5 and -4.8 kg [P < 0.001], respectively). HbA1c and BW reductions were consistently greater for semaglutide 1.0 mg versus 0.5 mg across background medication, diabetes duration and pancreatic beta-cell function subgroups. Adverse events with semaglutide were consistent with the glucagon-like peptide-1 receptor agonist class, with gastrointestinal events the most common. CONCLUSIONS Semaglutide was consistently efficacious across the continuum of diabetes care in a broad spectrum of patient subgroups with a range of clinical characteristics.

中文翻译:

基线特征和β细胞功能对每周一次皮下注射semaglutide的功效和安全性的影响:SUSTAIN 1-5试验的患者水平汇总分析。

目的评估相关患者水平特征对2型糖尿病患者皮下注射每周一次semaglutide的疗效和安全性的影响。材料和方法汇总的SUSTAIN 1-5(3a期)随机,对照试验的事后探索性研究分析了HbA1c和体重(BW)与基线相比的变化,以及达到复合终点的受试者比例(HbA1c <7.0%[ 53 mmol / mol]),在临床相关患者亚组中在第30周时未出现体重增加或严重/血糖确诊的症状性低血糖,并伴有semaglutide(0.5 / 1.0 mg):基线HbA1c(≤7.5%,> 7.5%-8.0%, > 8.0%-8.5%,> 8.5%-9.0%和> 9.0%),背景药物,糖尿病持续时间和胰腺β细胞功能。结果对于0.5 mg semaglutide,0.5 mg semaglutide的平均HbA1c减少量(%点)从最低到最高HbA1c亚组增加(-0.9%,-1.2%,-1.5%,-1.7%和-2.3%[亚组的影响:P = 0.247] ,和-semaglutide 1.0 mg的-1.1%,-1.4%,-1.9%,-2.1%和-2.7%[P = 0.045]),第30周的平均HbA1c范围为6.3%-7.3%和6.1%-6.9 %, 分别。相应的体重减少通常随着基线HbA1c的增加而降低(-4.4,-3.9,-3.9,-3.3和-2.9 kg [P = 0.004],以及-6.4,-5.9,-5.2,-4.5和-4.8 kg [P <0.001])。在背景药物,糖尿病持续时间和胰岛β细胞功能亚组中,semaglutide 1.0 mg的HbA1c和BW减少量始终比0.5 mg的量更大。semaglutide的不良反应与胰高血糖素样肽1受体激动剂类别一致,以胃肠道事件最为常见。结论Semaglutide在具有一系列临床特征的广泛患者亚组中,在糖尿病的连续治疗中一直有效。
更新日期:2019-11-15
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