Key result
Empagliflozin cuts CV death or HF hospitalization ~27% in malnourished HFrEF patients.
Why the study?
Does empagliflozin reduce the composite of cardiovascular death or hospitalization for worsening heart failure in patients with HFrEF regardless of malnutrition status?
RCT (n=3,676)
Does empagliflozin reduce the composite of cardiovascular death or hospitalization for worsening heart failure in patients with HFrEF regardless of malnutrition status?
Answers are grounded in this paper and cite their sources.
Empagliflozin is effective and safe in HFrEF patients regardless of baseline nutritional status, alleviating concerns about prescribing SGLT2 inhibitors to malnourished patients.
Background Malnutrition is common among patients with heart failure (HF) and reduced ejection fraction (HFrEF) and is associated with adverse events. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, can lead to loss of glucose and calories, raising concerns for physicians when prescribing SGLT2 therapy to malnourished heart failure patients. However, it remains unclear whether malnutrition affects the efficacy and safety of empagliflozin in this population. Objectives This study aimed to explore the association between malnutrition and adverse cardiovascular events in patients with HFrEF and to assess the impact of malnutrition on the efficacy and safety of empagliflozin in the EMPEROR-Reduced trial. Methods The risk of malnutrition was assessed at baseline using the validated Controlling Nutritional Status (CONUT) score. Patients were categorized into two groups: "malnutrition" (CONUT ≥2) and "no malnutrition" (CONUT <2). The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure. Results A total of 3,676 patients were included in the study, of which 2,039 (55.5%) were identified as malnourished. Over a median follow-up of 14.7 months, 807 primary outcomes were recorded. Patients with malnutrition showed a significantly higher risk of the primary outcome in both the empagliflozin and placebo groups (adjusted hazard ratios of 1.41 [95% confidence interval (CI), 1.13–1.78] and 1.45 [95% CI, 1.19–1.76], respectively). In comparison to placebo, empagliflozin reduced the risk of the primary outcome similarly in patients with and without malnutrition, with hazard ratios (95% CI) of 0.73 (0.58–0.92) and 0.78 (0.65–0.92), respectively (P-interaction = 0.74). Patients treated with empagliflozin had a lower risk of serious adverse events, regardless of their nutritional status. Conclusion Malnutrition was a marker of high cardiovascular risk. Patients with malnutrition benefit similarly to other patients from empagliflozin without an increased risk of serious adverse events.
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Li et al. (2025) conducted an RCT in Heart failure with reduced ejection fraction (HFrEF) (n=3,676). Empagliflozin vs. Placebo was evaluated on Composite of cardiovascular death or hospitalization for worsening heart failure (HR 0.73, 95% CI 0.58-0.92, p=0.74 for interaction). Empagliflozin reduced the risk of cardiovascular death or heart failure hospitalization similarly in HFrEF patients with and without malnutrition.
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