Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Gumi Hospital, Soonchunhyang University College of Medicine, Gumi, Korea.
Diabetes Metab J. 2024 Jul;48(4):730-739. doi: 10.4093/dmj.2023.0077. Epub 2024 May 20.
It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia.
This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment.
After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. -0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (-55.20% vs. -7.69%, P<0.001) without previously unknown adverse drug events.
The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin's preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.
众所周知，大量糖尿病患者同时患有血脂异常，这显著增加了心血管疾病（CVD）的风险。本研究旨在评估二甲双胍和阿托伐他汀联合药物的疗效和安全性，这两种药物广泛用于治疗糖尿病和血脂异常。
这是一项随机、双盲、安慰剂对照、平行分组和 III 期多中心研究，纳入了糖化血红蛋白（HbA1c）水平>7.0%且<10.0%、低密度脂蛋白胆固醇（LDL-C）>100 且<250mg/dL 的成年人。185 名符合条件的受试者被随机分配到联合组（二甲双胍+阿托伐他汀）、二甲双胍组（二甲双胍+阿托伐他汀安慰剂）和阿托伐他汀组（阿托伐他汀+二甲双胍安慰剂）。主要疗效终点为治疗结束时与基线相比 HbA1c 和 LDL-C 水平的变化百分比。
与基线相比，治疗 16 周后，与阿托伐他汀组相比，联合组的 HbA1c 显著降低了 0.94%（分别为 0.35%和-0.58%；P<0.0001），同时 HbA1c 升高的患者比例也分别为 62%和 15%，差异具有统计学意义（P<0.001）。与二甲双胍组相比，联合组 LDL-C 水平也显著降低（-55.20% vs. -7.69%，P<0.001），且未出现先前未知的药物不良反应。
与单独使用二甲双胍或阿托伐他汀相比，在糖尿病和血脂异常患者中，添加阿托伐他汀可显著改善 HbA1c 和 LDL-C 水平。本研究还表明，在运动和饮食控制不佳的 2 型糖尿病和血脂异常患者中，二甲双胍可预防阿托伐他汀升高血糖的作用。二甲双胍和阿托伐他汀联合治疗可能是一种有效的治疗方法，可降低 LDL-C 和血糖，从而降低糖尿病和血脂异常患者的 CVD 风险。
