Low blood pressure and the effect of empagliflozin in acute heart failure: An EMPULSE analysis
Abstract
Aims: Empagliflozin improves outcomes in acute heart failure (AHF). Patients with AHF and low blood pressure (BP) have poor prognosis. Whether empagliflozin is effective and safe in patients with AHF and low BP is currently unknown. The aim of this study was to assess the efficacy and safety of empagliflozin (vs. placebo) in patients with low BP - either systolic BP (SBP) <110 mmHg or diastolic BP (DBP) <70 mmHg - at randomization.
Methods and results: EMPULSE included 530 patients with AHF followed for 90 days. The primary outcome was a hierarchical composite of all-cause mortality, HF events, and Kansas City Cardiomyopathy Questionnaire total symptom score changes at 90 days tested using the win ratio (WR). Patients were required to have SBP ≥100 mmHg for randomization. A total of 131 (25%) patients had SBP <110 mmHg and 190 (36%) DBP <70 mmHg. In placebo, low BP was associated with more clinical and adverse events. Compared to placebo, BP changes with empagliflozin were of small magnitude (-2 to 2 mmHg), not reaching statistical significance. Patients presenting with low BP increased their BP, on average, throughout the 90-day follow-up, regardless of treatment group. Empagliflozin (vs. placebo) improved clinical outcomes regardless of BP at randomization, potentially with a larger magnitude of effect in patients presenting with low DBP at randomization: primary outcome WR = 1.48, 95% confidence interval (CI) 1.15-1.90, p = 0.0025; WR = 1.23, 95% CI 0.94-1.60 in DBP ≥70…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 530 participants or records.
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