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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M23-1490

摘要内容如下：

背景

新的糖尿病药物可能对死亡率、心血管结局和肾脏结局产生有益的影响。

目的

评价钠-葡萄糖协同转运蛋白-2（SGLT2）抑制剂、胰高血糖素样肽-1（GLP1）激动剂、二肽基肽酶-4（DPP4）抑制剂和长效胰岛素单药或联合治疗成人2型糖尿病（T2DM）的有效性、比较有效性和危害。

数据源

2010年至2023年1月发表的随机对照试验（RCT）的MEDLINE和EMBASE。

研究选择

持续至少52周的随机对照试验，包括至少500名接受合格药物治疗的成年T2DM患者，并报告任何相关结果。

数据提取

数据由一名评审员进行摘要，并由另一名评审员进行验证。对偏倚风险和证据确定性（Coe）进行了独立的双重评估。

数据综合

共确定了来自84个随机对照试验的130篇出版物。使用直接、间接和网络荟萃分析（NMA）的GRADE（建议评估、开发和评价的分级）标准对Coe进行评估；报告了最高的Coe。与常规治疗相比，SGLT2抑制剂和GLP1激动剂可降低全因死亡率（高Coe）和主要不良心血管事件（MACE）（中度至高Coe），SGLT2抑制剂可减少慢性肾病（CKD）和心力衰竭住院的进展，GLP1激动剂可减少卒中（高Coe），SGLT2抑制剂可减少严重不良事件和严重低血糖（高Coe）。这些结果未达到美国内科医师学会临床指南委员会预先确定的最小重要差异阈值。与常规治疗相比，胰岛素、Tirzepatide和DPP4抑制剂不能降低全因死亡率（低至高Coe）。与胰岛素相比，SGLT2抑制剂和GLP1激动剂可降低全因死亡率（低至中度Coe）。与DPP4抑制剂相比，GLP1激动剂可降低全因死亡率（中度Coe）。与DPP4抑制剂和磺酰脲类药物（SU）相比，SGLT2抑制剂可降低MACE（中度至高度Coe）。与SU和胰岛素相比，SGLT2抑制剂和GLP1激动剂可降低严重低血糖（低至高Coe）。

局限性

感兴趣的药物之间很少进行直接比较；NMA关于大多数结果的稀疏数据；由于基线患者特征和常规护理的差异而可能产生的不一致性；预先确定的亚组数据不足，包括人口统计学亚组、既往有心血管疾病的患者和未接受治疗的患者。

结论

在T2DM成人患者中，与常规治疗相比，SGLT2抑制剂和GLP1激动剂（而不是DPP4抑制剂、胰岛素或Tirzepatide）可降低全因死亡率和MACE。与常规治疗相比，SGLT2抑制剂可减少CKD进展和心力衰竭住院，GLP1激动剂可减少卒中。与胰岛素或SU相比，SGLT2抑制剂和GLP1激动剂的严重不良事件和严重低血糖发生率较低。

主要资金来源

美国内科医师学会。（普洛斯彼罗：CRD42022322129）。

英文原文如下：

Abstracts

BACKGROUND  Newer diabetes medications may have beneficial effects on mortality, cardiovascular outcomes, and renal outcomes.

PURPOSE  To evaluate the effectiveness, comparative effectiveness, and harms of sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) agonists, dipeptidyl peptidase-4 (DPP4) inhibitors, and long-acting insulins as monotherapy or combination therapy in adults with type 2 diabetes mellitus (T2DM).

DATA SOURCES  MEDLINE and EMBASE for randomized controlled trials (RCTs) published from 2010 through January 2023.

STUDY SELECTION  RCTs lasting at least 52 weeks that included at least 500 adults with T2DM receiving eligible medications and reported any outcomes of interest.

DATA EXTRACTION  Data were abstracted by 1 reviewer and verified by a second. Independent, dual assessments of risk of bias and certainty of evidence (CoE) were done.

DATA SYNTHESIS  A total of 130 publications from 84 RCTs were identified. CoE was appraised using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria for direct, indirect, and network meta-analysis (NMA); the highest CoE was reported. Compared with usual care, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (high CoE) and major adverse cardiovascular events (MACE) (moderate to high CoE), SGLT2 inhibitors reduce progression of chronic kidney disease (CKD) and heart failure hospitalizations and GLP1 agonists reduce stroke (high CoE), and SGLT2 inhibitors reduce serious adverse events and severe hypoglycemia (high CoE). The threshold for minimally important differences, which was predefined with the American College of Physicians Clinical Guidelines Committee, was not met for these outcomes. Compared with usual care, insulin, tirzepatide, and DPP4 inhibitors do not reduce all-cause mortality (low to high CoE). Compared with insulin, SGLT2 inhibitors and GLP1 agonists reduce all-cause mortality (low to moderate CoE). Compared with DPP4 inhibitors, GLP1 agonists reduce all-cause mortality (moderate CoE). Compared with DPP4 inhibitors and sulfonylurea (SU), SGLT2 inhibitors reduce MACE (moderate to high CoE). Compared with SU and insulin, SGLT2 inhibitors and GLP1 agonists reduce severe hypoglycemia (low to high CoE).

LIMITATIONS  Infrequent direct comparisons between drugs of interest; sparse data for NMA on most outcomes; possible incoherence due to differences in baseline patient characteristics and usual care; insufficient data on predefined subgroups, including demographic subgroups, patients with prior cardiovascular disease, and treatment-naive persons.

CONCLUSION  In adults with T2DM, SGLT2 inhibitors and GLP1 agonists (but not DPP4 inhibitors, insulin, or tirzepatide) reduce all-cause mortality and MACE compared with usual care. SGLT2 inhibitors reduce CKD progression and heart failure hospitalization and GLP1 agonists reduce stroke compared with usual care. Serious adverse events and severe hypoglycemia are less frequent with SGLT2 inhibitors and GLP1 agonists than with insulin or SU.

PRIMARY FUNDING SOURCE  American College of Physicians. (PROSPERO: CRD42022322129).

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