时间标签：数据日期 2026-10-31 · 生成时间 2026-11-01 05:30（Asia/Shanghai）｜ 检索窗口 PubMed edat 2026/10/28–2026/10/31 ｜ 情报发生日期 2026-10-31
研究问题
Type 2 diabetes mellitus (T2DM) remains a major global health challenge, with approximately 537 million adults affected worldwide in 2021.；Whereas RCTs establish causal efficacy under controlled conditions, real‐world evidence (RWE) is essential to confirm whether benefits translate to routine clinical practice, which encompasses broader patient populations, less controlled treatment conditions, and diverse background therapies., Post‐marketing RWE for enavogliflozin remains limited.
方法
Eligible participants were adults (≥19 years) with type 2 diabetes mellitus scheduled to initiate enavogliflozin 0.3 mg (Enavo) or enavogliflozin 0.3 mg/metformin 1000 mg FDC (EnavoMet) as part of routine clinical care.；Key exclusion criteria included type 1 diabetes, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, active malignancy, pregnancy, and participation in any interventional clinical trial within the preceding 3 months.；Six participants had recorded prior enavogliflozin use (Enavo, n = 2; EnavoMet, n = 4) and were included in the analyses; the protocol specified first administration of the study product.；Among EnavoMet‐group participants, prior metformin users received EnavoMet as a consolidation of their existing metformin regimen, with enavogliflozin added via the fixed‐dose combination product.
核心结论
However, notable imbalances were observed for SBP (SMD = 0.14), DBP (SMD = 0.19), TC (SMD = 0.24), and HDL‐C (SMD = 0.34), with higher values in the EnavoMet group.；In the Enavo group, mean HbA1c decreased from baseline by −0.416 pp (95% CI: −0.436, −0.396; n = 4196) at 12 weeks and by −0.688 pp (95% CI: −0.707, −0.668; n = 7003) at 24 weeks.；In the EnavoMet group, the corresponding reductions were −0.557 pp (95% CI: −0.602, −0.512; n = 1107) and −0.860 pp (95% CI: −0.902, −0.818; n = 1648), respectively. ‖ 结论：Informed consent: Written informed consent was obtained from all the participants.
局限
In this large prospective multicenter observational study of 8796 Korean patients with type 2 diabetes mellitus in routine primary care, enavogliflozin—used as a single‐pill formulation (Enavo group) or as a fixed‐dose combination with metformin (EnavoMet group)—was associated with reductions in HbA1c, FPG, body weight, and blood pressure over 24 weeks.；Treatment allocation was non‐randomized, the two groups differed in background antidiabetic regimen composition (confounding by indication), and no formal between‐group comparison was performed.；Patients may not spontaneously report mild or self‐limiting events, and clinicians in busy primary care settings may not systematically document all
对本项目的价值
★☆☆☆☆ 代谢轴既干预敏感性最高，也是老药新用供给最充足的来源。
全文来源
PMC JATS 全文（正文 22,695 字符，已过标题/DOI 逐字归属校验）
原文题录
- 英文标题：Real-world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24-week prospective multicenter observational study in Korea.
- 期刊与标识：J Diabetes Investig · PMID 42952084 · DOI 10.1111/jdi.70478
A 级证据分级：A 级（同行评议人体研究）
本文属人体研究证据，但需注意：观察性或小样本干预的结论不等于已证实临床获益；效应量与长期安全性仍需更大规模、更长随访的试验验证。
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