Department of Pharmacy Practice, Idaho State University College of Pharmacy-Alaska Campus, Anchorage, AK, USA.
Department of Pharmacy Practice and Administration, Idaho State University College of Pharmacy-Meridian Campus, Meridian, ID, USA.
Am J Health Syst Pharm. 2021 Feb 19;78(5):401-407. doi: 10.1093/ajhp/zxaa414.
In comparative randomized studies, use of insulin detemir has been consistently demonstrated to be associated with less weight gain than the industry standard, insulin glargine. However, the magnitude of the relative reduction in weight gain with use of insulin determir vs insulin glargine in regulatory studies (reported values ranged from 0.77 kg to 3.6 kg) may not be generalizable to patients in real-world practice conditions. A study was conducted to substantiate detemir's purported weight-sparing advantage over insulin glargine in newly treated patients with type 2 diabetes mellitus under the conditions found in a clinical practice setting.
A retrospective longitudinal cohort study design was applied in reviewing electronic medical records to identify insulin-naive, overweight patients with type 2 diabetes who received insulin detemir or insulin glargine therapy continued for up to 1 year. Patient weights at baseline and at each subsequent clinic visit after treatment initiation were identified. The primary outcome was the maximum weight increase from baseline after exposure to insulin detemir or glargine. The difference-in-differences (DiD) mean total body weight change was tested by analysis of covariance (ANCOVA).
One hundred nine patient records (56 of patients who received insulin glargine and 53 of patients who received insulin detemir) met study criteria and underwent full abstraction. The covariate-adjusted estimated mean change in body weight associated with use of insulin detemir vs insulin glargine was -1.5 kg (95% CI, -2.89 to -0.12 kg; P = 0.04).
The mean weight gain associated with detemir use was significantly less than the mean weight change observed with glargine use. The magnitude of weight change was consistent with that demonstrated in randomized controlled trials. These results further substantiate detemir's purported comparative weight-sparing properties under conditions found in a real-world practice setting.
在比较性随机研究中，已一致证实使用胰岛素地特胰岛素相较于行业标准药物——胰岛素甘精胰岛素，体重增加更少。然而，在监管研究中（报告的数值范围为 0.77 千克至 3.6 千克），与使用胰岛素甘精胰岛素相比，使用胰岛素地特胰岛素在体重增加方面的相对减少幅度可能无法推广到真实实践条件下的患者。本研究旨在证实，在临床实践环境中，与胰岛素甘精胰岛素相比，新诊断的 2 型糖尿病患者使用胰岛素地特胰岛素可在体重方面具有明显优势。
采用回顾性纵向队列研究设计，通过审查电子病历来识别新接受胰岛素地特胰岛素或胰岛素甘精胰岛素治疗且持续治疗时间长达 1 年的胰岛素初治、超重 2 型糖尿病患者。识别患者在治疗开始前后每次就诊时的体重。主要结局为暴露于胰岛素地特胰岛素或甘精胰岛素后从基线开始的最大体重增加。通过协方差分析（ANCOVA）对差异（DiD）平均体重总变化进行检验。
109 份患者记录（56 份接受胰岛素甘精胰岛素治疗，53 份接受胰岛素地特胰岛素治疗）符合研究标准并进行了完整提取。地特胰岛素与甘精胰岛素相比，调整协变量后体重的估计平均变化为-1.5 千克（95%置信区间，-2.89 至-0.12 千克；P = 0.04）。
与使用甘精胰岛素相比，使用地特胰岛素导致的体重增加明显更少。体重变化的幅度与随机对照试验中观察到的一致。这些结果进一步证实了在真实实践环境下，地特胰岛素具有减轻体重的优势。
