Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Albuminuria Irrespective of Baseline HbA1c Levels: A Participant‐Level Exploratory Analysis of the Randomised CONFIDENCE Trial
Authors' conclusion
Simultaneous initiation with finerenone and an SGLT2i reduced UACR compared with monotherapy and was well-tolerated irrespective of HbA1c levels.
Study context
- Population
- Adults with T2D, urinary albumin-to-creatinine ratio (UACR) 100–<5000 mg/g, estimated glomerular filtration rate (eGFR) 30–90 mL/min/1.73 m² and HbA1c <11% (<97 mmol/mol); baseline mean HbA1c 7.3% (SD 1.2%), eGFR 54.2 mL/min/1.73 m² (SD 17.1)781 with baseline HbA1c
- Participants
- 800 adults
- Comparison
- Finerenone + empagliflozin combination vs finerenone or empagliflozin monotherapy, by baseline HbA1c quartile
- Primary endpoint
- UACR change from baseline
- Follow-up
- Day 180
Methodological detailsprespecified, participant-level exploratory analysis
- Prespecified
- Participant-level exploratory analysis
Primary result
As reported in the abstract
Quartile 1 (HbA1c ≤6.4% [≤46 mmol/mol]; n=212): mean UACR change with combination
−53% [−63, −42] (95% CI)
Quartile 2 (HbA1c >6.4 and ≤7.1% [>46 and ≤54 mmol/mol]; n=190): mean UACR change with combination
−47% [−57, −34] (95% CI)
Quartile 3 (HbA1c >7.1 and ≤7.9% [>54 and ≤63 mmol/mol]; n=188): mean UACR change with combination
−63% [−70, −54] (95% CI)
Quartile 4 (HbA1c >7.9% [>63 mmol/mol]; n=191): mean UACR change with combination
−55% [−65, −42] (95% CI)
Further findings
Least-squares mean change, %
| Outcome | Combination | Empagliflozin |
|---|---|---|
| HbA1c change from baseline · Day 180 | −0.1 (95% CI −0.2–-0.0) | −0.1 (95% CI −0.2–-0.0) |
HbA1c change from baseline · Day 180
- No change in HbA1c with finerenone
- Change from baseline in HbA1c greatest in Quartile 4
Original publication
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