Scripps Whittier Diabetes Institute, La Jolla, CA, USA.
Rockwood Clinic, Spokane, WA, USA.
J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5.
To investigate the glycemic efficacy, effects on cardiovascular risk factors, and safety of exenatide once weekly (QW) in patients with type 2 diabetes over 7 years in the DURATION-1 study.
Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years. Efficacy analyses included changes from baseline in glycated hemoglobin (HbA) and cardiovascular risk factors.
Of 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment. Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA, -1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort. There were no unexpected safety findings.
Treatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors.
在 DURATION-1 研究中，调查每周一次（QW）给予艾塞那肽治疗 7 年对 2 型糖尿病患者的血糖疗效、心血管风险因素的影响及安全性。
患者最初被随机分为每周 2mg 艾塞那肽 QW 组或每日两次艾塞那肽组治疗 30 周，之后接受开放标签、不限定疗程的每周 2mg 艾塞那肽 QW 治疗，最长可达 7 年。疗效分析包括从基线糖化血红蛋白（HbA）和心血管风险因素的变化。
在意向治疗人群中，295 例患者中，122 例（41%）完成了 7 年的治疗。7 年完成治疗的患者从基线开始显示出持续的血糖改善（7 年最小二乘均数[LSM]变化的 HbA，-1.53%），并且多项心血管风险因素显著改善，包括体重、舒张压、总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇。未接受额外降糖治疗的 7 年完成治疗者（n=65 [53%]），与整个队列相比，HbA 改善相似，体重减轻幅度更大（7 年 LSM 变化，-6.46kg 与-3.87kg）。未发现意外的安全性发现。
艾塞那肽 QW 治疗 7 年与持续改善血糖控制和多项心血管风险因素相关。
