患者特征对每周一次司美格鲁肽与度拉糖肽疗效和安全性的影响：SUSTAIN 7 分析。
Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 analyses.
作者信息
Pratley Richard E, Aroda Vanita R, Catarig Andrei-Mircea, Lingvay Ildiko, Lüdemann Jörg, Yildirim Emre, Viljoen Adie
机构信息
Translational Research Institute, AdventHealth, Orlando, Florida, USA
Division of Endocrinology, Diabetes & Hypertension, Brigham and Women's Hospital, Boston, Massachusetts, USA.
出版信息
BMJ Open. 2020 Nov 16;10(11):e037883. doi: 10.1136/bmjopen-2020-037883.
OBJECTIVE
In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.
DESIGN
Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5-10, >10 years), HbA (≤7.5, >7.5-8.5, >8.5% (≤58, >58-69, >69 mmol/mol)) and body mass index (BMI) (<30, 30-<35, ≥35 kg/m).
SETTING
194 sites; 16 countries.
PARTICIPANTS
Subjects with T2D (n=1199) exposed to treatment.
INTERVENTIONS
Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.
PRIMARY AND SECONDARY OUTCOME MEASURES
Change in HbA (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.
RESULTS
HbA and BW reductions (estimated treatment difference ranges: -0.22 to -0.70%-point; -1.76 to -3.84 kg) and proportion of subjects achieving HbA targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.
CONCLUSIONS
Consistently greater improvements in HbA and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.
TRIAL REGISTRATION NUMBER
NCT02648204.
目的
在SUSTAIN 7研究中，与每周一次的度拉糖肽相比，每周一次的司美格鲁肽在2型糖尿病（T2D）患者中使糖化血红蛋白（HbA）降低幅度更大，体重（BW）减轻更多。本分析研究了具有临床意义的受试者特征对司美格鲁肽与度拉糖肽治疗效果的影响。
设计
按基线年龄（<65岁、≥65岁）、性别（男性、女性）、糖尿病病程（≤5年、>5至10年、>10年）、HbA（≤7.5%、>7.5至8.5%、>8.5%（≤58、>58至69、>69 mmol/mol））和体重指数（BMI）（<30、30至<35、≥35 kg/m²）进行分析。
地点
194个研究点；16个国家。
参与者
接受治疗的T2D患者（n = 1199）。
干预措施
司美格鲁肽0.5 mg与度拉糖肽0.75 mg（低剂量比较）；司美格鲁肽1.0 mg与度拉糖肽1.5 mg（高剂量比较），均为每周一次皮下注射。
主要和次要结局指标
从基线到第40周HbA的变化（主要终点）和BW的变化（确证性次要终点）；第40周达到HbA目标（<7%、≤6.5%（<53、≤48 mmol/mol））的受试者比例和体重减轻反应（≥5%、≥10%）；以及安全性。
结果
在每个亚组类别中，司美格鲁肽与度拉糖肽的大多数比较中，HbA和BW的降低幅度（估计治疗差异范围：-0.22至-百分之0.70；-1.76至-3.84 kg）以及达到HbA目标和体重减轻反应的受试者比例在统计学上显著更高，并且除了HbA亚组中低剂量比较的血糖控制情况外，这与亚组或剂量比较无关。胃肠道不良事件是两种治疗中最常见的，报告此类事件的女性多于男性，并且使用司美格鲁肽时，随着BMI增加而减少。
结论
无论年龄、性别、糖尿病病程、血糖控制情况和BMI如何，司美格鲁肽与度拉糖肽相比，HbA和BW始终有更大改善，这支持了司美格鲁肽在异质性T2D人群连续治疗过程中的疗效。
试验注册号
NCT02648204。
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