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Early changes in estimated glomerular filtration rate post-initiation of empagliflozin in EMPEROR-Reduced.
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- Author(s): Zannad F;Zannad F; Ferreira JP; Ferreira JP; Ferreira JP; Gregson J; Gregson J; Kraus BJ; Kraus BJ; Kraus BJ; Kraus BJ; Mattheus M; Mattheus M; Hauske SJ; Hauske SJ; Hauske SJ; Butler J; Butler J; Filippatos G; Filippatos G; Wanner C; Wanner C; Anker SD; Anker SD; Pocock SJ; Pocock SJ; Packer M; Packer M; Packer M
- Source:
European journal of heart failure [Eur J Heart Fail] 2022 Oct; Vol. 24 (10), pp. 1829-1839. Date of Electronic Publication: 2022 Jul 07.- Publication Type:
Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't- Language:
English - Source:
- Additional Information
- Corporate Authors:
- Source: Publisher: Wiley Country of Publication: England NLM ID: 100887595 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0844 (Electronic) Linking ISSN: 13889842 NLM ISO Abbreviation: Eur J Heart Fail Subsets: MEDLINE
- Publication Information: Publication: 2014- : Chichester : Wiley
Original Publication: Amsterdam ; New York : Elsevier Science, c1999- - Subject Terms:
- Abstract: Aims: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) may induce an early post-initiation decrease of estimated glomerular filtration rate (eGFR), which does not impact the SGLT2i benefits. The occurrence, characteristics, determinants, and clinical significance of an initial eGFR change among patients with heart failure with reduced ejection fraction require further study. In this study we aimed to describe eGFR change from randomization to week 4 (as percent of change relative to randomization) and assess its impact in EMPEROR-Reduced.
Methods and Results: Landmark analyses (week 4) were performed. eGFR change was available in 3547 patients out of 3730 (95%). The tertiles of post-initiation % eGFR change for empagliflozin were: tertile 1 (T1) ≤-11.4%; T2 ≥-11.4% to ≤-1.0% and T3 ≥0.0%. The placebo group tertiles were: T1 ≤-6.5%; T2 ≥-6.4% to ≤+3.6%; and T3 ≥+3.6%. On average, empagliflozin induced a leftward distributional shift of initial eGFR changes of -2.5 ml/min/1.73 m 2 versus placebo. In the empagliflozin group, after covariate adjustment, the risk of cardiovascular and renal outcomes did not differ between patients in whom early post-treatment initiation eGFR decreased (T1) and patients in whom it increased (T3). However, in the placebo group, patients in whom early post-treatment initiation eGFR decreased (T1) had a higher risk of sustained worsening kidney function and all-cause mortality compared to patients in whom eGFR increased (T3) (hazard ratio [HR] 2.38, 95% confidence interval [CI] 1.25-4.55 and HR 1.37, 95% CI 1.01-1.85, respectively).
Conclusion: A mild eGFR decrease may be expected after the initiation of empagliflozin, and it is not associated with untoward heart failure, mortality, or kidney safety events. Clinicians should not be concerned with early eGFR changes post-initiation of empagliflozin.
(© 2022 European Society of Cardiology.) - Comments: Comment in: Eur J Heart Fail. 2022 Oct;24(10):1840-1843. (PMID: 35999649)
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- Molecular Sequence: ClinicalTrials.gov NCT03057977
- Accession Number: HDC1R2M35U (empagliflozin)
0 (Sodium-Glucose Transporter 2 Inhibitors) - Publication Date: Date Created: 20220617 Date Completed: 20231012 Latest Revision: 20231012
- Publication Date: 20231013
- Accession Number: 10.1002/ejhf.2578
- Accession Number: 35711093
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