Gebrie Desye, Manyazewal Tsegahun, A Ejigu Dawit, Makonnen Eyasu
School of Pharmacy, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.
Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Diabetes Metab Syndr Obes. 2021 Jul 24;14:3345-3359. doi: 10.2147/DMSO.S312997. eCollection 2021.
This study aimed to compare glycemic control and risk of cardiovascular outcomes of metformin-insulin versus metformin-sulfonylurea combination therapies in type 2 diabetes mellitus.
We conducted a comparative cross-sectional study in five tertiary level hospitals in Addis Ababa, Ethiopia. We enrolled 321 patients with type 2 diabetes mellitus who were on continuous treatment follow-up on either metformin-insulin or metformin-sulfonylurea combination therapy. We interviewed the participants and reviewed their medical records to investigate medication efficacy, safety, and adherence. The primary outcome measure was glycemic control and the secondary outcome measures were composite cardiovascular outcomes.
Of the total participants enrolled, 50.5% (n = 162) were those who received metformin-insulin and 49.5% (n = 159) metformin-sulfonylurea combination therapies for a median of 48 months follow-up. The reduction of Hb1Ac levels was comparable between the metformin-insulin (-1.04 ± 0.96%) and metformin-sulfonylurea (-1.02 ± 1.03%), p = 0.912. Patients who received metformin-sulfonylurea had 4.3 times more likely to have achieved target HbA1c level compared to those who received metformin-insulin, < 0.001, adjusted odds ratio (AOR) with 95% CI = 4.31[1.79-10.32]. Risk of composite cardiovascular outcomes was higher in metformin-insulin group (40.5% versus 34.0%), = 0.021. Co-morbidities, body mass index, systolic blood pressure, and HbA1c had a significant association with composite cardiovascular outcomes. Reductions of bodyweight, HDL-C, LDL-C, triglycerides levels, and microvascular complications were different between the two groups, < 0.05.
High proportion of patients who received metformin-sulfonylurea achieved target HbA1c level and had less composite cardiovascular outcomes compared to those who received metformin-insulin. However, these findings have to be confirmed with randomized control trials to determine risks associated with insulin use, while efficacy is maintained as second-line treatment in patients with type 2 diabetes mellitus.
本研究旨在比较二甲双胍-胰岛素联合治疗与二甲双胍-磺脲类联合治疗对2型糖尿病患者血糖控制及心血管结局风险的影响。
我们在埃塞俄比亚亚的斯亚贝巴的五家三级医院开展了一项比较性横断面研究。我们纳入了321例接受二甲双胍-胰岛素或二甲双胍-磺脲类联合治疗并持续接受治疗随访的2型糖尿病患者。我们对参与者进行了访谈并查阅了他们的病历，以调查药物疗效、安全性和依从性。主要结局指标为血糖控制情况，次要结局指标为复合心血管结局。
在纳入的全部参与者中，50.5%（n = 162）接受二甲双胍-胰岛素治疗，49.5%（n = 159）接受二甲双胍-磺脲类联合治疗，中位随访时间为48个月。二甲双胍-胰岛素组（-1.04±0.96%）和二甲双胍-磺脲类组（-1.02±1.03%）的Hb1Ac水平降低幅度相当，p = 0.912。与接受二甲双胍-胰岛素治疗的患者相比，接受二甲双胍-磺脲类治疗的患者达到目标HbA1c水平的可能性高4.3倍，p<0.001，调整后的优势比（AOR）及95%置信区间为4.31[1.79 - 10.32]。二甲双胍-胰岛素组的复合心血管结局风险更高（40.5%对34.0%），p = 0.021。合并症、体重指数、收缩压和HbA1c与复合心血管结局显著相关。两组间体重、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯水平及微血管并发症的降低情况存在差异，p<0.05。
与接受二甲双胍-胰岛素治疗的患者相比，接受二甲双胍-磺脲类治疗的患者中有更高比例达到目标HbA1c水平，且复合心血管结局更少。然而，这些发现必须通过随机对照试验来证实，以确定胰岛素使用相关风险，同时在2型糖尿病患者中将其作为二线治疗维持疗效。
