Efficacy and safety of metformin versus empagliflozin on chronic kidney disease progression (MET-EMPA-CKD): a randomized controlled trial
Abstract
Background: Chronic kidney disease (CKD) is a devastating progressive condition accompanied with high morbidity and mortality rates. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have recently proven their renoprotective effects, whereas evidence for metformin remains limited but suggestive of potential benefit. This study aimed at comparing the efficacy and safety of metformin versus empagliflozin, a SGLT2 inhibitor, on retarding CKD progression with exploring supposed mechanistic pathways in clinical settings.
Methods: In this 12-month randomized controlled trial, 120 moderate CKD patients were randomized into three groups: metformin 1000 mg/day (n = 40) or empagliflozin 10 mg/day (n = 40), both added orally to standard treatment, or control who continued standard of care (n = 40). The primary outcome was changes in estimated glomerular filtration rate (eGFR). Secondary analyses assessed percent changes of urinary albumin-to-creatinine ratio (uACR), transforming growth factor-β1 (TGF-β1), kidney injury molecule (KIM)-1, and beclin-1 (an autophagy biomarker). Other metabolic and safety issues were also assessed.
Results: 118 patients completed the study with comparable baseline data. Metformin and empagliflozin halted the decline in eGFR at study end with adjusted mean difference ± SE: 8.91 ± 1.92 (p˂0.001) and 5.1 ± 1.89 (p = 0.03), respectively, compared to control group. Metformin preserved its effect in diabetics and non-diabetics, with superiority than…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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