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首页> 外文期刊>Journal of Clinical & Translational Endocrinology >Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (50 years) obese patients with type 2 diabetes mellitus
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Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (50 years) obese patients with type 2 diabetes mellitus

机译：胰高血糖素样肽1受体激动剂利西拉来与二肽基肽酶4抑制剂西他列汀在年轻（<50岁）肥胖的2型糖尿病患者中的疗效和安全性

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Objective To compare the efficacy and safety of the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide with the dipeptidyl peptidase-4 inhibitor sitagliptin in patients aged <50 years affected by obesity and type 2 diabetes mellitus (T2DM). Materials and methods This was a 24-week, double-blind, randomized, parallel-group study. Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20?μg once-daily injection ( n ?=?158) or once-daily oral sitagliptin 100?mg ( n ?=?161). The primary endpoint was the proportion of patients with a glycated hemoglobin (HbA 1c ) <7% and ≥5% weight loss at 24 weeks. Results The proportion of patients that achieved the primary endpoint was 12.0% for lixisenatide versus 7.5% for sitagliptin; weighted average of proportion difference: 4.6%, p ?=?0.1696). A total of 40.7% of patients achieved HbA 1c <7% with lixisenatide versus 40.0% with sitagliptin. Lixisenatide produced greater reductions in body weight (LS mean difference:??1.3?kg, p ?=?0.0006) and postprandial plasma glucose after a standardized meal test (LS mean difference:??34.4?mg/dL [?1.9?mmol/L], p ?=?0.0001) versus sitagliptin. There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia. Conclusion In obese patients aged <50 years with T2DM, the proportion of patients with an HbA 1c <7% with weight loss ≥5% was similar between groups. Lixisenatide, however, resulted in significantly greater reductions in body weight and postprandial plasma glucose excursions than sitagliptin. Tolerability was similar between groups.
机译：目的比较每日一次餐后胰高血糖素样肽-1受体激动剂利西拉来和二肽基肽酶-4抑制剂西他列汀在肥胖和2型糖尿病（T2DM）患病年龄＜50岁的患者中的疗效和安全性。材料和方法这是一项为期24周的双盲，随机，平行分组研究。肥胖的二甲双胍控制不充分的T2DM患者被随机分为利西拉肽每天一次注射20μg（n = 158）或每天口服西他列汀100 mg（n = 161）。主要终点是24周糖化血红蛋白（HbA 1c）<7％且体重减轻≥5％的患者比例。结果利西拉来达到主要终点的患者比例为12.0％，西他列汀为7.5％。比例差的加权平均值：4.6％，p = 0.1696）。总共40.7％的患者使用利西拉来达到HbA 1c <7％，而西他列汀达到40.0％。标准化膳食测试后，利西拉来肽的体重（LS平均差：？1.3？kg，p？= 0.0006）和餐后血浆葡萄糖减少的幅度更大（LS平均差：？34.4？mg / dL [？1.9？mmol] / L]，相对于西他列汀p ＝ 0.0001）。发生治疗的不良事件发生率相似（63.9％vs. 60.9％）和发生严重的治疗性不良事件（1.9％vs. 1.9％），症状性低血糖发生率低（0.6％vs. 1.9％）。利西拉来和西他列汀分别未见严重低血糖的情况。结论在年龄小于50岁的T2DM肥胖患者中，HbA 1c <7％且体重减轻≥5％的患者比例在两组之间相似。然而，与西他列汀相比，利西拉来导致的体重减少和餐后血浆葡萄糖偏移显着更大。两组之间的耐受性相似。

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