Renal and systemic hemodynamic effects of empagliflozin: Three randomized, double blind, placebo controlled cross-over trials
Abstract
Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve renal outcomes in type 2 diabetes mellitus (DM2) and chronic kidney disease (CKD). A decrease in renal blood flow (RBF) with attenuation of glomerular hyperfiltration may contribute to this. We examined renal and systemic hemodynamic effects of SGLT2i in relevant patient categories.
Methods: Using a double-blind placebo controlled cross-over design we randomized patients with DM2 and estimated glomerular filtration rate (eGFR) >60 ml/min/1.73m 2 (n=16), patients with DM2 and eGFR 20-60 ml/min/1.73m 2 (n=17) and patients with non-diabetic CKD and eGFR 20-60 ml/min/1.73m 2 (n=16) to empagliflozin 10 mg daily or placebo for four weeks and crossed over to the opposite treatment after two-week washout. RBF was measured with 82 Rubidium positron emission tomography/computed tomography ( 82 Rb-PET/CT), GFR as plasma clearance of 99m Technetium-diethylene-triamine-pentaacetate, while 24-hour blood pressure (BP) and total peripheral vascular resistance (TVR) were recorded using the commercially available Mobil-O-graph.
Results: Compared to placebo empagliflozin reduced RBF by 6% in the DM2-CKD group (p<0.001), while there were non-significant decreases of 4% in the DM2 group and 1% in the CKD group (p=0.29 and 0.72). Empagliflozin reduced GFR, BP and TVR in all groups. Although total renal vascular resistance (RVR) remained unchanged, calculations based on Gomez’ equations revealed a reduction of post-glomerular…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, 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: 17 participants or records.
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