Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy & School of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, China.
Department of Pharmacy, The Affiliated Suzhou Science & Technology Town Hospital of Nanjing Medical University, Suzhou, Jiangsu, China.
J Clin Pharm Ther. 2022 Feb;47(2):237-242. doi: 10.1111/jcpt.13572. Epub 2021 Nov 9.
Dapagliflozin was the first oral treatment approved in type 1 diabetes mellitus (T1DM) patients, simultaneously improving body weight. However, the time course and dose effect of dapagliflozin on loss of weight in T1DM patients was still unknown. The present study aimed to investigate quantitative relationship between dapagliflozin and loss of weight in T1DM patients based on Model-based Meta-analysis.
Five dapagliflozin dosage groups, two of them were 5 mg/day and three of them were 10 mg/day, 1612 T1DM patients were analysed with maximal effect (E ) model, and evaluation index was change rate of body weight from baseline value.
In these T1DM patients, dosages were not incorporated into model, indicating no significant dose-response relationship between 5 and 10 mg/day affecting loss of weight. E and the treatment duration to reach half of the maximal effects (ET ) of dapagliflozin influencing loss of weight in T1DM patients were -4.9% and 10.4 weeks, and the duration to achieve 25%, 50%, 75%, and 80% (plateau) of E were 3.5, 10.4, 31.2, and 41.6 weeks.
It was the first time to explore quantitative relationship between dapagliflozin and loss of weight in T1DM patients. To achieve the plateau period in loss of weight, 5 mg/day dapagliflozin was required for at least 41.6 weeks.
达格列净是首个在 1 型糖尿病（T1DM）患者中获批的口服治疗药物，同时可改善体重。然而，达格列净对 T1DM 患者体重减轻的时间过程和剂量效应仍不清楚。本研究旨在通过基于模型的荟萃分析，研究达格列净与 T1DM 患者体重减轻之间的定量关系。
对 1612 例 T1DM 患者进行了最大效应（E）模型分析，这些患者的达格列净剂量分别为 5mg/天和 10mg/天的 5 个剂量组，评价指标为体重从基线值的变化率。
在这些 T1DM 患者中，剂量未纳入模型，表明 5mg/天和 10mg/天之间没有明显的剂量-反应关系影响体重减轻。E 和达到达格列净最大效应（ET）一半的治疗时间（T1DM 患者体重减轻的影响因素）分别为-4.9%和 10.4 周，达到 25%、50%、75%和 80%（平台）E 的时间分别为 3.5、10.4、31.2 和 41.6 周。
这是首次探索达格列净与 T1DM 患者体重减轻之间的定量关系。要达到体重减轻的平台期，每天 5mg 达格列净至少需要 41.6 周。
