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September 29, 2022
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Empagliflozin HF benefits consistent across albumin levels: EMPEROR-Pooled

Fact checked byRichard Smith

In adults with HF, empagliflozin was associated with a reduction in new macroalbuminuria in patients with macroalbuminuria at baseline compared with placebo.

Empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) was also associated with an increase in rate of remission to sustained normoalbuminuria or microalbuminuria.

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In a secondary analysis of the EMPEROR-Pooled trial , researchers also found that the observed association of empagliflozin with CV and kidney outcomes in people with HF was consistent across albumin-to-creatinine ratio categories.

João Pedro Ferreira

“This study confirms that albuminuria above the normal range was frequent (microalbuminuria 32% and macroalbuminuria 11%) and associated with poor prognosis in patients with HF and showed that empagliflozin was associated with a reduction in new-onset macroalbuminuria and an increase in sustained remission from macroalbuminuria to normoalbuminuria or microalbuminuria in patients with HF, regardless of ejection fraction or diabetes status,” João Pedro Ferreira, MD, PhD, research doctor at Clinical Investigation Centre Pierre Drouin (CIC-P) in Nancy, France, and colleagues wrote in JAMA Cardiology. “Furthermore, empagliflozin was associated with improved cardiovascular and kidney outcomes irrespective of baseline urine albumin-to-creatinine ratio.”

In a post hoc analysis, Ferreira and colleagues analyzed data from 9,673 participants with HF from the EMPEROR-Pooled analysis using combined individual patient data from the EMPEROR-Reduced and EMPEROR-Preserved trials (mean age, 70 years; 63% men). EMPEROR-Preserved was conducted from March 27, 2017, to April 26, 2021; EMPEROR-Reduced was conducted from April 6, 2017, to May 28, 2020.

Within the cohort, 5,552 patients had normoalbuminuria, defined as a urine albumin-to-creatinine ratio (UACR) of 300 mg/g.

An increase in events was observed among participants with higher UACR levels. The association of empagliflozin with CV death or HF hospitalization was consistent across UACR categories, with an HR of 0.8 for normoalbuminuria (95% CI, 0.69-0.92), 0.74 for microalbuminuria (95% CI, 0.63-0.86) and 0.78 for macroalbuminuria (95% CI, 0.63-0.98; P for interaction trend = .71).

Treatment with empagliflozin was associated with lower incidence of new macroalbuminuria (HR = 0.81; 95% CI, 0.7-0.94; P = .005) and an increase in rate of remission to sustained normoalbuminuria or microalbuminuria (HR = 1.31; 95% CI, 1.07-1.59; P = .009). There was no association with empagliflozin treatment and a reduction in UACR in the overall population; however, UACR was reduced in patients with diabetes, who had higher UACR levels than participants without diabetes.

“Empagliflozin was not associated with a reduction in UACR in the overall population; however, UACR was reduced in patients with diabetes, who had higher UACR levels than patients without diabetes,” the researchers wrote. “In addition, a trend toward UACR reduction was observed in patients with higher UACR levels at baseline. These findings support the potential need for an elevated albuminuria level for reduction of albuminuria to be observed with empagliflozin.”