二甲双胍与其他口服抗糖尿病药物治疗日本 2 型糖尿病患者的疗效和安全性：网络荟萃分析。
Efficacy and Safety of Metformin Versus the Other Oral Antidiabetic Drugs in Japanese Type 2 Diabetes Patients: A Network Meta-analysis.
机构信息
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, 3-25-8 Nishishinbashi, Minato-ku, Tokyo, Japan.
Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., 1-13-1, Kyobashi, Chuo-ku, Tokyo, Japan.
出版信息
Adv Ther. 2022 Jan;39(1):632-654. doi: 10.1007/s12325-021-01979-1. Epub 2021 Nov 30.
INTRODUCTION
Although metformin is recommended as a first-line treatment for patients with type 2 diabetes (T2D) in Western countries, no specific treatment is recommended in Japan, and various agents are used. Metformin has long been used at low doses in Japan, and information regarding its effect at the maximum maintenance dose is lacking. Here, we compared the efficacy and safety of metformin at 1500 mg/day with those of the other oral anti-diabetic drugs (OADs) approved in Japan.
METHODS
Randomized controlled trials comparing a change in hemoglobin A1c (HbA1c) from baseline at 12 weeks or later (ΔHbA1c) among OADs (including placebo) as a first-line treatment in adult patients with T2D were selected by systematic review with comprehensive searching of CENTRAL, MEDLINE, Ichushi Web, and EMBASE and manual searching of clinical trial registries. The ΔHbA1c and incidence of hypoglycemia were compared among OAD treatments using Bayesian network meta-analysis (NMA). The relative risk (RR) of the incidence of hypoglycemia was determined relative to that of placebo.
RESULTS
Forty-six randomized controlled trials were identified in the systematic review, and 37 studies, comprising 38 different types of treatments, including placebos, were selected for the NMA of ΔHbA1c. Compared with metformin 1500 mg/day, 20 OAD treatments were significantly less effective in reducing HbA1c from baseline (differences from metformin 1500 mg/day: 0.40-0.96%). Two treatments (glimepiride 2 mg/day and pioglitazone 45 mg/day) showed greater mean reductions in HbA1c from baseline than metformin 1500 mg/day (- 0.38% and - 0.03%), although these differences were not significant. Regarding the incidence of hypoglycemia, only pioglitazone 30 mg/day among 31 treatments showed a lower RR (< - 0.01), whereas 23 treatments showed a significantly higher RR (1.02-66.71) than metformin 1500 mg/day.
CONCLUSION
The NMA suggested a preferable efficacy and safety profile of metformin 1500 mg/day compared with the other OADs approved in Japan.
简介
尽管二甲双胍被推荐为西方国家 2 型糖尿病（T2D）患者的一线治疗药物，但日本并未推荐特定的治疗方法，而是使用了各种药物。在日本，二甲双胍长期以来一直以低剂量使用，缺乏关于其在最大维持剂量下效果的信息。在这里，我们比较了 1500mg/天的二甲双胍与日本批准的其他口服降糖药（OAD）的疗效和安全性。
方法
通过系统评价，全面检索了 CENTRAL、MEDLINE、Ichushi Web 和 EMBASE，并手动检索了临床试验注册处，筛选出了比较 OAD（包括安慰剂）作为 T2D 成年患者一线治疗时，12 周或更长时间（ΔHbA1c）基线血红蛋白 A1c（HbA1c）变化的随机对照试验。采用贝叶斯网络荟萃分析（NMA）比较 OAD 治疗之间的ΔHbA1c 和低血糖发生率。低血糖发生率的相对风险（RR）相对于安慰剂确定。
结果
系统评价中确定了 46 项随机对照试验，其中 37 项研究（包括 38 种不同类型的治疗方法，包括安慰剂）被纳入 NMA 的 ΔHbA1c 分析。与二甲双胍 1500mg/天相比，20 种 OAD 治疗方案在降低 HbA1c 方面明显效果较差（与二甲双胍 1500mg/天相比：0.40-0.96%）。两种治疗方法（格列美脲 2mg/天和吡格列酮 45mg/天）与二甲双胍 1500mg/天相比，HbA1c 从基线的平均降低幅度更大（-0.38%和-0.03%），尽管这些差异并不显著。关于低血糖发生率，在 31 种治疗方法中，只有吡格列酮 30mg/天的 RR 较低（< -0.01），而 23 种治疗方法的 RR 明显高于二甲双胍 1500mg/天（1.02-66.71）。
结论
NMA 表明，与日本批准的其他 OAD 相比，二甲双胍 1500mg/天具有更好的疗效和安全性。
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