Micale Sara J, Khatounabadi Shahabodin, Kane Michael P, Busch Robert S, Bakst Gary, Abelseth Jill M, Hamilton Robert A
Albany College of Pharmacy and Health Sciences, Albany, NY, USA.
The Endocrine Group, LLP, Albany, NY, USA.
J Pharm Technol. 2014 Aug;30(4):118-124. doi: 10.1177/8755122513518189. Epub 2014 Jan 7.
Traditional diabetes therapies have been associated with weight gain, hypoglycemia, and/or high secondary failure rates. Glucagon-like peptide-1 (GLP-1) analog use is associated with a minimal risk of hypoglycemia, a persistent average weight loss of 2 to 3 kg, and sustained efficacy even after 3 years of use. Presently, 3 GLP-1 analogs are commercially available in the United States. To evaluate the real-world clinical utility of once weekly exenatide in type 2 diabetes mellitus (T2DM) patients who previously received once or twice daily GLP-1 therapy. In this pre-post observational study, electronic medical records (EMRs) were reviewed to identify patients meeting all study criteria. Data collected included baseline patient demographic information, duration of diabetes, disease states, medications, pertinent laboratory data, blood pressure, height, weight, and reported adverse drug events. Primary (changes in A1C and percentage of patients reporting adverse effects of therapy) and secondary (percentage of patients with A1C of <7% and changes in weight, blood pressure, and lipids) outcomes were evaluated using appropriate statistical analysis. EMRs of 78 patients met all study criteria. Baseline patient demographic information included an average age of 61 ± 12 years, an average duration of T2DM of 14 ± 6 years, 59% of patients were male, and 93.6% were Caucasian. The baseline average body mass index was 39 ± 9.2, and mean A1C was 7.47 ± 1.45%. After a minimum of 3 months (average = 5.6 months) switchover, there were significant decreases in A1C (-0.35%; = .0067) and weight (-1.6 kg; = .0151). There were no significant changes in blood pressure or lipid levels. Two patients (2.5%) discontinued once weekly exenatide due to adverse reactions. Once weekly exenatide was generally well tolerated and significantly reduced A1C levels and body weight in patients with T2DM when switched from a shorter-acting GLP-1 analog.
传统的糖尿病治疗方法与体重增加、低血糖和/或高继发性失败率相关。使用胰高血糖素样肽-1(GLP-1)类似物发生低血糖的风险极小,平均体重持续减轻2至3千克,且即使使用3年后仍能保持疗效。目前,有3种GLP-1类似物在美国上市。为了评估每周一次的艾塞那肽在既往接受每日一次或两次GLP-1治疗的2型糖尿病(T2DM)患者中的实际临床应用价值。在这项前后对照观察性研究中,对电子病历(EMR)进行了审查,以确定符合所有研究标准的患者。收集的数据包括患者基线人口统计学信息、糖尿病病程、疾病状态、用药情况、相关实验室数据、血压、身高、体重以及报告的药物不良事件。使用适当的统计分析方法评估主要结局(糖化血红蛋白[ A1C ]的变化以及报告治疗不良反应的患者百分比)和次要结局(A1C小于7%的患者百分比以及体重、血压和血脂的变化)。78例患者的电子病历符合所有研究标准。患者基线人口统计学信息包括平均年龄61±12岁,T2DM平均病程14±6年,59%的患者为男性,93.6%为白种人。基线平均体重指数为39±9.2,平均A1C为7.47±1.45%。在至少3个月(平均=5.6个月)的转换期后,A1C显著降低(-0.35%;P=.0067),体重显著减轻(-1.6千克;P=.0151)。血压和血脂水平无显著变化。两名患者(2.5%)因不良反应停用了每周一次的艾塞那肽。从短效GLP-1类似物转换为每周一次的艾塞那肽后,T2DM患者对其总体耐受性良好,且A1C水平和体重显著降低。