The eGFR Slope After Starting Therapy with Empagliflozin in a Cohort of Patients with Diabetes and Stage 3 CKD: Is It Really an Issue? TEMPOREALE Real-World Study.

<b>Introduction.</b> Chronic kidney disease (CKD) is a major complication in type 2 diabetes (T2D), leading to increased cardiovascular risk. Empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), has shown cardiorenal benefits in clinical trials, but real-world data in patients with moderate CKD are limited. <b>Objectives.</b> To retrospectively evaluate changes in estimated glomerular filtration rate (eGFR) following empagliflozin initiation in T2D patients with CKD (KDIGO 3A and 3B stages), focusing on the occurrence and impact of early eGFR decline ("dip") and associated metabolic outcomes and cardiovascular risk factors. <b>Methods.</b> This multicenter study included adult T2D patients with eGFR 30-60 mL/min/1.73 m² who started empagliflozin between October 2023 and April 2024. Clinical parameters were collected at baseline, 1 month, and 6 months. Subgroup analyses were conducted by CKD stage and eGFR dip status (>10% decline at 1 month). <b>Results.</b> Among 166 patients, 21.6% experienced an eGFR dip. Overall, eGFR increased by 2.75 mL/min/1.73m² at 6 months (p < 0.0001), with more pronounced improvement in non-dippers and CKD 3A patients. In dippers, eGFR partially recovered. HbA1c decreased by ~4 mmol/mol (despite use of concomitant glucose-lowering drugs decreased at empagliflozin initiation), weight by ~2 kg, and systolic blood pressure by ~4 mmHg. Empagliflozin discontinuation occurred in 4.2% of patients, mainly due to genitourinary infections. Discussion. Empagliflozin was associated with stabilization or improvement in renal function and modest metabolic benefits in T2D patients with CKD stage 3. The eGFR dip was infrequent and transient, supporting the continued use of empagliflozin in this population in real-world settings.

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PubMed
Published
2025-12-19
DOI
https://doi.org/10.69097/42-06-2025-04
Primary Topic
Diabetes Treatment and Management
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article

The eGFR Slope After Starting Therapy with Empagliflozin in a Cohort of Patients with Diabetes and Stage 3 CKD: Is It Really an Issue? TEMPOREALE Real-World Study.

Roberta Serra, Antonio Belviso, Maria Elena Malighetti, Paolo Erpoli et al.
PubMed
Diabetes Treatment and Management
article

The eGFR Slope After Starting Therapy with Empagliflozin in a Cohort of Patients with Diabetes and Stage 3 CKD: Is It Really an Issue? TEMPOREALE Real-World Study.

Roberta Serra, Antonio Belviso, Maria Elena Malighetti, Paolo Erpoli, Diana Donini, Laura Molteni, M. Laneri, Giovanni Saccà
article en

Abstract

<b>Introduction.</b> Chronic kidney disease (CKD) is a major complication in type 2 diabetes (T2D), leading to increased cardiovascular risk. Empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), has shown cardiorenal benefits in clinical trials, but real-world data in patients with moderate CKD are limited. <b>Objectives.</b> To retrospectively evaluate changes in estimated glomerular filtration rate (eGFR) following empagliflozin initiation in T2D patients with CKD (KDIGO 3A and 3B stages), focusing on the occurrence and impact of early eGFR decline ("dip") and associated metabolic outcomes and cardiovascular risk factors. <b>Methods.</b> This multicenter study included adult T2D patients with eGFR 30-60 mL/min/1.73 m² who started empagliflozin between October 2023 and April 2024. Clinical parameters were collected at baseline, 1 month, and 6 months. Subgroup analyses were conducted by CKD stage and eGFR dip status (>10% decline at 1 month). <b>Results.</b> Among 166 patients, 21.6% experienced an eGFR dip. Overall, eGFR increased by 2.75 mL/min/1.73m² at 6 months (p < 0.0001), with more pronounced improvement in non-dippers and CKD 3A patients. In dippers, eGFR partially recovered. HbA1c decreased by ~4 mmol/mol (despite use of concomitant glucose-lowering drugs decreased at empagliflozin initiation), weight by ~2 kg, and systolic blood pressure by ~4 mmHg. Empagliflozin discontinuation occurred in 4.2% of patients, mainly due to genitourinary infections. Discussion. Empagliflozin was associated with stabilization or improvement in renal function and modest metabolic benefits in T2D patients with CKD stage 3. The eGFR dip was infrequent and transient, supporting the continued use of empagliflozin in this population in real-world settings.

PubMedVol. 42(6)
Fondazione Roma (IT), Istituto Nazionale di Fisica Nucleare, Sezione di Lecce (IT), National Centre for Disease Prevention and Control (IT), Ospedale di Rivoli (IT), Ospedale San Carlo (IT), Accademia Italiana Medicina Osteopatica (IT), Casa di Cura Columbus (IT), ASST Melegnano e della Martesana (IT), Ospedale San Giuseppe (IT)
Good health and well-being
Openalex Percentile: Top 26%
Diabetes Treatment and Management
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