Amylin Pharmaceuticals, Inc, San Diego, CA 92121 , USA.
Postgrad Med. 2012 Jul;124(4):33-40. doi: 10.3810/pgm.2012.07.2568.
In this pooled analysis, the efficacy and tolerability of exenatide once weekly (EQW) in patients categorized by baseline concomitant glucose-lowering therapy were evaluated.
This post hoc analysis included data from the intent-to-treat populations of 7 randomized controlled trials in which patients with type 2 diabetes mellitus were treated with EQW for 24 to 30 weeks. Patients were classified into subgroups on the basis of their baseline glucose-lowering therapy: diet and exercise only, metformin (MET) only, MET + sulfonylurea (SU), SU ± other (thiazolidinedione [TZD] only or MET + TZD), or TZD ± MET. Changes from baseline in key efficacy endpoints and tolerability were analyzed by baseline concomitant glucose-lowering therapy group.
A total of 1719 patients were included. Treatment with EQW was associated with significant improvements from baseline in glycated hemoglobin levels, fasting glucose levels, and body weight in all of the groups. There were significant decreases from baseline for both systolic blood pressure and diastolic blood pressure in the MET and MET + SU groups, and a significant decrease in systolic blood pressure in the diet and exercise group. Lipid profiles generally improved in the diet and exercise, MET only, MET + SU, and TZD ± MET groups. Overall, the most frequent adverse events with EQW treatment, other than hypoglycemia, were nausea (14.7%), diarrhea (10.9%), and nasopharyngitis (7.2%). There was a higher incidence of hypoglycemia when EQW was added to regimens that included an SU.
The addition of EQW for 24 to 30 weeks to regimens that included a wide variety of background glucose-lowering therapies was associated with significant improvements in glycemic control and weight loss. The tolerability profile of EQW appeared to be similar regardless of background therapy, except for a higher incidence of minor hypoglycemia when EQW was added to regimens that included an SU.
在这项汇总分析中，评估了基线伴随降糖治疗的患者中每周一次艾塞那肽（EQW）的疗效和耐受性。
这项事后分析包括 7 项随机对照试验的意向治疗人群的数据，这些试验中，2 型糖尿病患者接受 EQW 治疗 24 至 30 周。根据基线降糖治疗，患者被分为亚组：仅饮食和运动、仅二甲双胍（MET）、MET+磺酰脲（SU）、SU±其他（噻唑烷二酮[TZD]仅或 MET+TZD）或 TZD±MET。按基线伴随的降糖治疗组分析关键疗效终点和耐受性的变化。
共纳入 1719 例患者。在所有组中，与基线相比，EQW 治疗均显著改善了糖化血红蛋白水平、空腹血糖水平和体重。MET 和 MET+SU 组的收缩压和舒张压均显著下降，饮食和运动组的收缩压显著下降。饮食和运动、仅 MET、MET+SU 和 TZD±MET 组的血脂谱普遍改善。总体而言，除低血糖外，EQW 治疗最常见的不良事件是恶心（14.7%）、腹泻（10.9%）和鼻咽炎（7.2%）。当 EQW 与包括 SU 的方案联合使用时，低血糖的发生率更高。
在包括各种背景降糖治疗的方案中，添加 24 至 30 周的 EQW 与血糖控制和体重减轻的显著改善相关。EQW 的耐受性似乎与背景治疗无关，除了当 EQW 与包括 SU 的方案联合使用时，低血糖的发生率更高。
