medwireNews: Starting empagliflozin as soon as feasible after hospital admission for acute heart failure (HF) reduces symptom burden and the risk for repeat episodes and mortality over the following 3 months, report the EMPULSE investigators.
Moreover, the sodium-glucose cotransporter (SGLT)2 inhibitor, given at the standard dose of 10 mg/day, was well tolerated in this population, which included people with both de novo and decompensated chronic HF.
“Because patients hospitalized for acute heart failure are often aggressively treated with diuretics and other vasoactive agents, it was previously unclear whether an SGLT2 inhibitor would increase the risk for worsening renal function, volume depletion and ketoacidosis,” say Adriaan Voors (University Medical Center Groningen, the Netherlands) and study co-authors.
In EMPULSE, volume depletion occurred in 12.7% and 10.2% of the empagliflozin and placebo groups, respectively, acute renal failure in 7.7% and 12.1%, and urinary tract infection in 4.2% and 6.4%. Rates of severe hypotension and hypoglycemia were also similar between the two groups and there were no instances of ketoacidosis.
Adriaan Voors discusses the EMPULSE trial of empagliflozin given just after stabilization of de novo or decompensated chronic heart failure (5:21).
The intention-to-treat analysis included 530 participants, who were a median age of around 70 years; approximately two-thirds were men and about 45% had type 2 diabetes. Participants started the study treatments while still in hospital, as soon as possible after stabilization. The median time from admission to randomization was 3 days, making EMPULSE distinct from SOLOIST-WHF, where more than half of the participants were randomized after hospital discharge.
During 90 days of follow-up, which the team notes is “often considered the vulnerable phase of heart failure,” 4.2% of people in the empagliflozin group died, compared with 8.3% of those in the placebo group, and the corresponding rates of additional HF events were 10.6% versus 14.7%.
Over this period, people taking empagliflozin achieved an adjusted mean 36.2-point improvement in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (scale of 0–100), and those given placebo achieved a 31.7-point improvement.
The researchers combined all three of these outcome measures into their primary endpoint and calculated the win ratio, which indicates the number of times that a participant given empagliflozin will have a better outcome than one given placebo in a direct comparison. The win ratio was 1.36, significantly in favor of empagliflozin.
“We believe that the primary endpoint is meaningful because it allows the hierarchical assessment of benefit across three fundamental goals of care: improvement of survival, reduction of HF [events], and improvement of symptoms,” write Voors and team in Nature Medicine.
The benefits of empagliflozin were generally consistent in multiple subgroups, including people with de novo or decompensated chronic HF, with or without diabetes, with or without chronic renal disease, and with reduced or preserved ejection fraction.
“The results of EMPULSE therefore extend and complement those of EMPEROR-Reduced and EMPEROR-Preserved by focusing on patients hospitalized for acute heart failure across the range of ejection fraction,” say the researchers.
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