Physicians East, Greenville, North Carolina.
Meridien Research, Bradenton, Florida.
Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
The efficacy and safety of semaglutide vs comparators in non-elderly (<65 years) and elderly (≥65 years) patients with type 2 diabetes (T2D) across the SUSTAIN 1-5 trials were evaluated. Patients were randomized to once-weekly subcutaneous semaglutide (0.5 or 1.0 mg) vs placebo, sitagliptin, exenatide or insulin. The primary objective was change in HbA1c and secondary objectives were changes in body weight and safety. Mean HbA1c decreased from baseline by 1.2%-1.5% and 1.5%-1.9% vs 0%-0.9% (non-elderly, n = 3045) and by 1.3%-1.5% and 1.2%-1.8% vs 0.2%-1.0% (elderly, n = 854) with semaglutide 0.5 and 1.0 mg vs comparators. Similar reductions from baseline in mean body weight with semaglutide occurred in both age groups. Similar proportions of patients experienced adverse events; premature treatment discontinuations were higher in elderly vs non-elderly patients. No increased risk of severe or blood glucose-confirmed hypoglycaemia was seen with semaglutide vs comparators between age groups. Semaglutide had a comparable efficacy and safety profile in non-elderly and elderly patients across the SUSTAIN 1-5 trials, making it an effective treatment option for elderly patients with T2D.
在 SUSTAIN 1-5 试验中，评估了司美格鲁肽与对照药物在非老年（<65 岁）和老年（≥65 岁）2 型糖尿病（T2D）患者中的疗效和安全性。患者被随机分配至每周一次皮下注射司美格鲁肽（0.5 或 1.0mg）或安慰剂、西格列汀、艾塞那肽或胰岛素。主要终点为 HbA1c 的变化，次要终点为体重变化和安全性。与对照药物相比，司美格鲁肽 0.5mg 和 1.0mg 使非老年（n=3045）和老年（n=854）患者的平均 HbA1c 分别从基线下降 1.2%-1.5%和 1.5%-1.9%和 0%-0.9%，1.3%-1.5%和 1.2%-1.8%。两组患者的平均体重均有相似的下降。两组患者发生不良反应的比例相似；老年患者的提前停药率高于非老年患者。与对照药物相比，司美格鲁肽在各年龄组中均未增加严重或血糖确认的低血糖风险。司美格鲁肽在 SUSTAIN 1-5 试验中在非老年和老年患者中具有相似的疗效和安全性，是老年 T2D 患者的有效治疗选择。
