Blonde L, Klein E J, Han J, Zhang B, Mac S M, Poon T H, Taylor K L, Trautmann M E, Kim D D, Kendall D M
Ochsner Clinic Foundation, New Orleans, LA, USA.
Diabetes Obes Metab. 2006 Jul;8(4):436-47. doi: 10.1111/j.1463-1326.2006.00602.x.
Exenatide, an incretin mimetic for the adjunct treatment of type 2 diabetes (DM2), reduced A1C and weight in 30-week placebo-controlled trials. This analysis examined the effects of exenatide on glycaemic control and weight over an 82-week period in patients with DM2 unable to achieve adequate glycaemic control with sulphonylurea (SU) and/or metformin (MET).
This interim analysis is of 314 patients who received exenatide in the 30-week placebo-controlled trials and subsequently in 52 weeks of open-label uncontrolled extension studies for 82 weeks of exenatide in total. Patients continued their SU and/or MET regimens throughout.
Patients completed 82 weeks of exenatide treatment [n = 314, 63% M, age 56 +/- 10 years, weight 99 +/- 21 kg, body mass index 34 +/- 6 kg/m2, A1C 8.3 +/- 1.0% (mean +/- SD)]. Reduction in A1C from baseline to week 30 [-0.9 +/- 0.1% (mean +/- SE)] was sustained to week 82 (-1.1 +/- 0.1%), with 48% of patients achieving A1C < or = 7% at week 82. At week 30, exenatide reduced body weight (a secondary endpoint) from baseline (-2.1 +/- 0.2 kg), with progressive reduction at week 82 (-4.4 +/- 0.3 kg). Similar results were observed for the intent-to-treat population (n = 551), with reductions in A1C and weight at week 82 of -0.8 +/- 0.1% and -3.5 +/- 0.2 kg respectively. The 82-week completer cohort showed statistically significant improvement in some cardiovascular risk factors. The most frequent adverse events were generally mild-to-moderate nausea and hypoglycaemia.
In summary, 82 weeks of adjunctive exenatide treatment in patients with DM2 treated with SU and/or MET resulted in sustained reduction in A1C and progressive reduction in weight, as well as improvement in some cardiovascular risk factors.
艾塞那肽是一种用于2型糖尿病（DM2）辅助治疗的肠促胰岛素类似物，在为期30周的安慰剂对照试验中可降低糖化血红蛋白（A1C）水平并减轻体重。本分析研究了在使用磺脲类药物（SU）和/或二甲双胍（MET）无法实现充分血糖控制的DM2患者中，艾塞那肽在82周期间对血糖控制和体重的影响。
本中期分析纳入了314例患者，这些患者在为期30周的安慰剂对照试验中接受了艾塞那肽治疗，随后又在为期52周的开放标签非对照延长期研究中接受了艾塞那肽治疗，总计82周。患者在整个过程中继续其SU和/或MET治疗方案。
患者完成了82周的艾塞那肽治疗[n = 314，男性占63%，年龄56±10岁，体重99±21 kg，体重指数34±6 kg/m²，A1C 8.3±1.0%（均值±标准差）]。从基线到第30周A1C的降低幅度为[-0.9±0.1%（均值±标准误）]，持续至第82周（-1.1±0.1%），48%的患者在第82周时A1C≤7%。在第30周时，艾塞那肽使体重（次要终点）较基线下降（-2.1±0.2 kg），在第82周时进一步下降（-4.4±0.3 kg）。在意向性治疗人群（n = 551）中观察到了类似结果，在第82周时A1C和体重分别下降了-0.8±0.1%和-3.5±0.2 kg。82周完成治疗的队列在一些心血管危险因素方面显示出统计学上的显著改善。最常见的不良事件一般为轻至中度恶心和低血糖。
总之，在接受SU和/或MET治疗的DM2患者中，82周的艾塞那肽辅助治疗导致A1C持续降低、体重逐渐减轻，以及一些心血管危险因素得到改善。
