Miyoshi Hideaki, Baxter Mike, Kimura Takeshi, Hattori Masakatsu, Morimoto Yukiko, Marinkovich Dion, Tamiwa Masami, Hirose Takahisa
Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Sanofi, Reading, UK.
Diabetes Ther. 2021 May;12(5):1341-1357. doi: 10.1007/s13300-021-01041-x. Epub 2021 Mar 17.
Basal-bolus (BB) and premixed insulin regimens may lower fasting plasma glucose (FPG) and postprandial plasma glucose (PPG), but are complex to use and associated with weight gain and hypoglycaemia. Although randomized controlled trials and prospective observational studies in insulin-naïve Japanese patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs) initiating these regimens have been conducted, real-world data are lacking. This study describes the characteristics of patients initiating these regimens in routine clinical practice and identifies the course and outcomes of therapy in the year following initiation.
Adults with T2D initiating BB or premixed regimens following OAD therapies held in a Japanese electronic medical record database were identified (2010-2019). Subcohorts were determined by treatment changes during ≤ 12 months of follow-up (no change, intensified, switched, discontinued). Outcomes included change in glycated haemoglobin levels (HbA1c), probability of first reaching HbA1c < 7% (stratified by baseline OAD number, HbA1c and age), and hypoglycaemia incidence.
The main cohorts comprised 1315 BB and 1195 premixed therapy initiators. Most individuals (67.9%) initiated BB as inpatients; 50.8% switched at a mean of 47.6 days. Mean HbA1c lowering was - 2.5% for BB and - 1.4% for premixed regimens (no change cohorts). Overall, a greater proportion achieved HbA1c < 7% if they were (at baseline) taking fewer OADs, in a lower HbA1c category, and aged ≥ 65 years. Hypoglycaemia incidence (< 70 mg/dl) was higher with BB than premixed regimens and lower in patients aged < 65 years.
Greater HbA1c reductions, but a higher incidence of hypoglycaemia, were reported with BB versus premixed regimens, while both cohorts demonstrated clinically meaningful reductions in HbA1c during follow-up. After initiation, most premixed regimens remained unchanged, whereas switches from BB to less intensive regimens were numerous, in accordance with the use of BB for a limited duration to improve FPG and PPG control.
基础-餐时（BB）胰岛素方案和预混胰岛素方案可降低空腹血糖（FPG）和餐后血糖（PPG），但使用复杂，且与体重增加和低血糖相关。尽管已经对初治的2型糖尿病（T2D）日本患者进行了随机对照试验和前瞻性观察性研究，这些患者口服降糖药（OADs）控制不佳且开始使用这些方案，但缺乏真实世界的数据。本研究描述了在常规临床实践中开始使用这些方案的患者特征，并确定了开始治疗后一年的治疗过程和结局。
在日本电子病历数据库中识别出在OAD治疗后开始使用BB或预混方案的T2D成人患者（2010-2019年）。亚组根据随访≤12个月期间的治疗变化确定（无变化、强化、转换、停用）。结局包括糖化血红蛋白水平（HbA1c）的变化、首次达到HbA1c<7%的概率（按基线OAD数量、HbA1c和年龄分层）以及低血糖发生率。
主要队列包括1315名开始使用BB的患者和1195名开始使用预混治疗的患者。大多数患者（67.9%）作为住院患者开始使用BB；50.8%的患者在平均47.6天时转换治疗方案。对于BB方案，平均HbA1c降低2.5%，对于预混方案为1.4%（无变化队列）。总体而言，如果（基线时）服用的OAD较少、HbA1c类别较低且年龄≥65岁，则更大比例的患者HbA1c<7%。BB方案的低血糖发生率（<70mg/dl）高于预混方案，且在年龄<65岁的患者中较低。
与预混方案相比，BB方案报告的HbA1c降低幅度更大，但低血糖发生率更高，而两个队列在随访期间HbA1c均有临床意义的降低。开始治疗后，大多数预混方案保持不变，而从BB转换为强度较低方案的情况较多，这与使用BB方案的时间有限以改善FPG和PPG控制一致。
