Chan Juliana C N, Paldánius Päivi M, Mathieu Chantal, Stumvoll Michael, Matthews David R, Del Prato Stefano
Department of Medicine & Therapeutics, Hong Kong Institute of Diabetes and Obesity and Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China.
Children's Hospital, Helsinki University and Helsinki University Hospital, Helsinki, Finland.
Diabetes Obes Metab. 2021 Jan;23(1):245-251. doi: 10.1111/dom.14192. Epub 2020 Sep 29.
We analysed glycaemic durability (sustained glycaemic control) with early combination therapy (metformin plus vildagliptin) versus metformin monotherapy, among patients with type 2 diabetes diagnosed before (young-onset [YOD]) and after (late-onset [LOD]) the age of 40 years, enrolled in the VERIFY trial. The primary endpoint was time to initial treatment failure (TF), defined as HbA1c of 7.0% or higher at two consecutive scheduled visits after randomization. The time to secondary TF was assessed when both groups were receiving and failing on the combination. A total of 186 (9.3%) patients had YOD and 1815 (90.7%) had LOD with a mean age difference of 20.4 years. Compared with metformin monotherapy, early combination reduced the risk of time to initial TF for both YOD (48%, P < .0006) and LOD (46%, P < .0001). With early combination, risk for time to secondary TF was reduced by 48% (P < .0035) in YOD and 24% (P < .0009) in LOD. Both treatment approaches were well tolerated with no unexpected safety concerns. In treatment-naïve patients with YOD (HbA1c 6.5%-7.5%), an early combination strategy improved attainment of the glycaemic target with durability and delayed treatment escalation compared with initial metformin monotherapy.
在纳入VERIFY试验的2型糖尿病患者中，我们分析了早期联合治疗（二甲双胍加维格列汀）与二甲双胍单药治疗相比的血糖耐久性（持续血糖控制）情况，这些患者分别在40岁之前（早发型[YOD]）和之后（晚发型[LOD]）被诊断出患有2型糖尿病。主要终点是首次治疗失败（TF）的时间，定义为随机分组后连续两次预定访视时糖化血红蛋白（HbA1c）达到7.0%或更高。当两组都接受联合治疗且治疗失败时，评估二次TF的时间。共有186例（9.3%）患者为早发型，1815例（90.7%）为晚发型，平均年龄差为20.4岁。与二甲双胍单药治疗相比，早期联合治疗降低了早发型（降低48%，P <.0006）和晚发型（降低46%，P <.0001）首次TF时间的风险。采用早期联合治疗时，早发型二次TF时间的风险降低了48%（P <.0035），晚发型降低了24%（P <.0009）。两种治疗方法耐受性良好，没有意外的安全问题。在未经治疗的早发型患者（HbA1c 6.5%-7.5%）中，与初始二甲双胍单药治疗相比，早期联合治疗策略提高了血糖目标的达成率，具有耐久性，并延迟了治疗升级。
