Randomized, Placebo-Controlled Trial on the Renal and Systemic Hemodynamic Effects of Empagliflozin
Abstract
Introduction 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. 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 per 1.73 m2 (n = 16), patients with DM2 and eGFR from 20 to 60 ml/min per 1.73 m2 (n = 17), and patients with nondiabetic CKD and eGFR from 20 to 60 ml/min per 1.73 m2 (n = 16) to empagliflozin 10 mg daily or placebo for 4 weeks and crossed over to the opposite treatment after 2-week washout. RBF was measured with 82Rubidium-positron emission-tomography/computed-tomography, glomerular filtration rate (GFR) with 99mTechnetium-diethylene-triamine-pentaacetate-clearance. A Mobil-O-graph was used to record 24-hour blood pressure (BP) and total vascular resistance (TVR). Results Compared to placebo, empagliflozin reduced RBF by 6% in the DM2-CKD group (P < 0.001) with nonsignificant decreases of 4% in the DM2 group and 1% in the CKD group (P = 0.29 and 0.72, respectively). Empagliflozin reduced GFR, BP, and TVR in all groups, whereas renal vascular resistance (RVR) remained unchanged. Conclusion Empagliflozin reduced RBF in patients with DM2 and CKD, whereas GFR, BP, and TVR were…
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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