Lee Kuang-Tso, Yeh Yung-Hsin, Chang Shang-Hung, See Lai-Chu, Lee Cheng-Hung, Wu Lung-Sheng, Liu Jia-Rou, Kuo Chi-Tai, Wen Ming-Shien
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei Department of Public Health, College of Medicine, Chang Gung University Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, Taiwan.
Medicine (Baltimore). 2017 Jul;96(28):e7507. doi: 10.1097/MD.0000000000007507.
Early type 2 diabetes mellitus (DM) may only require lifestyle modifications for glycemic control without the need for oral hypoglycemic agents (OHAs). Metformin is believed to improve cardiovascular outcomes in patients with DM, and it is considered to be a first-line therapy. However, it is unclear whether metformin is beneficial for patients with a new diagnosis of DM compared to those who do not need OHAs for glycemic control.Data were obtained from a population-based health care database in Taiwan. Patients with a new diagnosis of DM were enrolled if they received metformin monotherapy only between 1999 and 2010. A 4:1 propensity score-matched cohort of patients with a new diagnosis of DM who did not take OHAs or insulin during follow-up was also enrolled. The primary study endpoint was the occurrence of major adverse cardiovascular events (MACEs). The time to the endpoints was compared between groups using Cox proportional hazards models.A total of 474,410 patients with DM were enrolled. During a mean 5.8 years of follow-up, the incidence of MACEs was 1.072% (1072 per 100,000 person-years) in the metformin monotherapy group versus 1.165% in the lifestyle modification group (those who did not take OHAs) (P < .001). After adjusting for confounders, metformin independently protected the DM patients from MACEs (hazard ratio: 0.83, P < .001). The metformin group also had an improved MACE-free survival profile from year 1 to year 12 (P < .001).In addition to lifestyle modifications, the patients with a new diagnosis of DM treated with metformin monotherapy had a lower MACE rate than those who did not take OHAs. Our findings suggest that metformin may be given early to patients with a new diagnosis of DM, even when they do not need OHAs for glycemic control.
早期2型糖尿病(DM)可能仅需通过生活方式的改变来控制血糖,而无需口服降糖药(OHAs)。二甲双胍被认为可改善糖尿病患者的心血管结局,被视为一线治疗药物。然而,与那些血糖控制无需OHAs的患者相比,二甲双胍对新诊断的糖尿病患者是否有益尚不清楚。
数据来自台湾一个基于人群的医疗保健数据库。新诊断为糖尿病的患者若在1999年至2010年间仅接受二甲双胍单药治疗,则被纳入研究。还纳入了一个4:1倾向评分匹配队列的新诊断糖尿病患者,这些患者在随访期间未服用OHAs或胰岛素。主要研究终点是主要不良心血管事件(MACEs)的发生情况。使用Cox比例风险模型比较各组达到终点的时间。
共纳入474,410例糖尿病患者。在平均5.8年的随访期间,二甲双胍单药治疗组的MACEs发生率为1.072%(每10万人年1072例),而生活方式改变组(未服用OHAs的患者)为1.165%(P<0.001)。在调整混杂因素后,二甲双胍可独立保护糖尿病患者免受MACEs影响(风险比:0.83,P<0.001)。二甲双胍组从第1年到第12年的无MACE生存情况也有所改善(P<0.001)。
除生活方式改变外,接受二甲双胍单药治疗的新诊断糖尿病患者的MACE发生率低于未服用OHAs的患者。我们的研究结果表明,即使新诊断的糖尿病患者血糖控制无需OHAs,也可早期给予二甲双胍治疗。