Empagliflozin and Rapid Kidney Function Decline Incidence in Type 2 Diabetes : An Exploratory Analysis From the EMPA-REG OUTCOME Trial
© 2023 The Authors..
Rationale & Objective: Kidney function progressively declines in most patients with type 2 diabetes (T2DM). Many develop progressive chronic kidney disease (CKD), but some experience a more rapid decline, with a greater risk of kidney failure and cardiovascular disease. In EMPA-REG OUTCOME, empagliflozin was associated with slower kidney disease progression. This post hoc analysis evaluated the effect of empagliflozin (pooled doses) on the prevalence of a "rapid decliner" phenotype, defined by an annual estimated glomerular filtration rate (eGFR) decline of >3 mL/min/1.73 m2.
Study Design: This was an exploratory analysis of EMPA-REG OUTCOME, a large randomized, double-blind, placebo-controlled trial in adults with T2DM, established cardiovascular disease and an eGFR of ≥30 mL/min/1.73 m2.
Setting & Participants: Analysis was undertaken on 6,967 participants (99.2%) in whom serial eGFR data was available.
Interventions: Patients were randomized (1:1:1) to empagliflozin 10 mg, 25 mg, or placebo in addition to standard of care.
Outcomes: Annual change in eGFR over the maintenance phase of treatment (week 4 to last value on treatment) was calculated using linear regression models. Logistic regression analysis was used to investigate differences in rapid decline between the treatment groups.
Results: Over the study period, a rapid decliner phenotype was observed in 188 (9.5%) participants receiving placebo and 134 (3.4%) receiving empagliflozin. After adjusting for other risk factors, this equated to a two-third reduction in odds (OR, 0.32; 95% CI, 0.25-0.40; P < 0.001) among participants receiving empagliflozin versus placebo. A comparable risk reduction was observed using a threshold of eGFR decline of >5 mL/min/1.73 m2/y (empagliflozin vs placebo, 43 [1.1%] vs 44 [2.2%] participants; OR, 0.47; 95% CI, 0.31-0.72; P < 0.001).
Limitations: This is a post hoc analysis of a trial undertaken in participants with T2DM and CVD. Generalization of findings to other settings remains to be established.
Conclusions: Patients receiving empagliflozin were significantly less likely to experience a rapid decline in eGFR over a median of 2.6 years of exposure to the study drug.
Funding: The Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.
Trial Registration: clinicaltrials.gov ID: NCT01131676.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
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| Enthalten in: |
Kidney medicine - 6(2024), 3 vom: 01. März, Seite 100783 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hadjadj, Samy [VerfasserIn] |
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| Links: |
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| Themen: |
Chronic kidney disease |
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| Anmerkungen: |
Date Revised 01.03.2024 published: Electronic-eCollection ClinicalTrials.gov: NCT01131676 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.xkme.2023.100783 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM36909705X |
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| 100 | 1 | |a Hadjadj, Samy |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Empagliflozin and Rapid Kidney Function Decline Incidence in Type 2 Diabetes |b An Exploratory Analysis From the EMPA-REG OUTCOME Trial |
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| 500 | |a Date Revised 01.03.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT01131676 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023 The Authors. | ||
| 520 | |a Rationale & Objective: Kidney function progressively declines in most patients with type 2 diabetes (T2DM). Many develop progressive chronic kidney disease (CKD), but some experience a more rapid decline, with a greater risk of kidney failure and cardiovascular disease. In EMPA-REG OUTCOME, empagliflozin was associated with slower kidney disease progression. This post hoc analysis evaluated the effect of empagliflozin (pooled doses) on the prevalence of a "rapid decliner" phenotype, defined by an annual estimated glomerular filtration rate (eGFR) decline of >3 mL/min/1.73 m2 | ||
| 520 | |a Study Design: This was an exploratory analysis of EMPA-REG OUTCOME, a large randomized, double-blind, placebo-controlled trial in adults with T2DM, established cardiovascular disease and an eGFR of ≥30 mL/min/1.73 m2 | ||
| 520 | |a Setting & Participants: Analysis was undertaken on 6,967 participants (99.2%) in whom serial eGFR data was available | ||
| 520 | |a Interventions: Patients were randomized (1:1:1) to empagliflozin 10 mg, 25 mg, or placebo in addition to standard of care | ||
| 520 | |a Outcomes: Annual change in eGFR over the maintenance phase of treatment (week 4 to last value on treatment) was calculated using linear regression models. Logistic regression analysis was used to investigate differences in rapid decline between the treatment groups | ||
| 520 | |a Results: Over the study period, a rapid decliner phenotype was observed in 188 (9.5%) participants receiving placebo and 134 (3.4%) receiving empagliflozin. After adjusting for other risk factors, this equated to a two-third reduction in odds (OR, 0.32; 95% CI, 0.25-0.40; P < 0.001) among participants receiving empagliflozin versus placebo. A comparable risk reduction was observed using a threshold of eGFR decline of >5 mL/min/1.73 m2/y (empagliflozin vs placebo, 43 [1.1%] vs 44 [2.2%] participants; OR, 0.47; 95% CI, 0.31-0.72; P < 0.001) | ||
| 520 | |a Limitations: This is a post hoc analysis of a trial undertaken in participants with T2DM and CVD. Generalization of findings to other settings remains to be established | ||
| 520 | |a Conclusions: Patients receiving empagliflozin were significantly less likely to experience a rapid decline in eGFR over a median of 2.6 years of exposure to the study drug | ||
| 520 | |a Funding: The Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance | ||
| 520 | |a Trial Registration: clinicaltrials.gov ID: NCT01131676 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Chronic kidney disease | |
| 650 | 4 | |a diabetes mellitus | |
| 650 | 4 | |a estimated glomerular filtration rate | |
| 650 | 4 | |a kidney function | |
| 650 | 4 | |a randomized controlled trials | |
| 700 | 1 | |a Cooper, Mark E |e verfasserin |4 aut | |
| 700 | 1 | |a Steubl, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Petrini, Michaela |e verfasserin |4 aut | |
| 700 | 1 | |a Hantel, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Mattheus, Michaela |e verfasserin |4 aut | |
| 700 | 1 | |a Wanner, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Merlin C |e verfasserin |4 aut | |
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