LB005KIDNEY implications of the initial egfr response to SGLT2 inhibition with empagliflozin: the ‘egfr dip’ in empa-REG outcome
Abstract
Empagliflozin (EMPA) reduces cardiovascular and renal risk in patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD). EMPA induces an initial ‘dip’ in estimated glomerular filtration rate (eGFR). Although considered to be of haemodynamic origin and largely reversible, this needs to be better understood. We investigated whether the initial eGFR dip after EMPA initiation was influenced by baseline characteristics and/or might have an impact on the EMPA-induced risk reduction in kidney outcomes.
In the EMPA-REG OUTCOME trial, patients with T2D and established CVD were treated (1:1:1) with EMPA 10 mg, 25 mg or placebo (PBO), in addition to standard of care. In this post hoc analysis, 6,668 participants who received at least one dose of study drug and had an available eGFR value at both baseline and Week 4 were categorised by initial percentage eGFR change from baseline. A multivariate logistic regression model was used to identify which baseline characteristics are predictive of an initial eGFR dip >10% in EMPA-treated participants versus PBO. Across these predictive baseline factors, we investigated the occurrence of incident or worsening nephropathy, hard kidney outcomes (defined as doubling of serum creatinine with eGFR [MDRD] ≤45 ml/min/1.73 m2 or initiation of renal replacement therapy or death from renal disease), and kidney safety (narrow standardized MedDRA query acute renal failure). The impact of an eGFR dip >10% on the risk reduction with…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6,668 participants or records.
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