Disclosures: Butler reports he received consultant fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Ltd and Vifor. Please see the study for all other authors’ relevant financial disclosures.
April 16, 2021
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Empagliflozin improves outcomes in HFrEF, regardless of baseline health status

Disclosures: Butler reports he received consultant fees from Boehringer Ingelheim, Cardior, CVRx, Foundry, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Ltd and Vifor. Please see the study for all other authors’ relevant financial disclosures.
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The benefits of empagliflozin compared with placebo for HF with reduced ejection fraction occurred regardless of health status at baseline, according to a secondary analysis of the EMPEROR-Reduced trial.

In addition, treatment with the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) was associated with improved health-related quality of life outcomes that were sustained at 12 months.

For this analysis researchers evaluated whether the benefits of empagliflozin varied by baseline health status and impacted patient-centered outcomes in HFrEF, as measured by KCCQ score. Data were derived from Butler J, et al. Eur Heart J. 2021;doi:10.1093/eurheartj/ehaa1007.

As Healio previously reported, empagliflozin improved CV and renal outcomes in patients with HFrEF, regardless of diabetes status, according to findings from the EMPEROR-Reduced trial presented at the 2020 European Society of Cardiology Congress.

Javed Butler

“It is important to assess the benefit of novel therapies on clinically relevant endpoints across the spectrum of disease severity, as has been done previously with ACE inhibitors, beta-blockers and mineralocorticoid receptor antagonists in HFrEF,” Cardiology Today Editorial Board Member Javed Butler, MD, MPH, MBA, FACC, FAHA, professor and chairman of the department of medicine at the University of Mississippi Medical Center, and colleagues wrote. “Patients with more advanced disease may or may not respond similarly to those with milder symptoms and functional impairment.”

For this analysis, published in the European Heart Journal, researchers evaluated whether the benefits of empagliflozin varied by baseline health status and impacted patient-centered outcomes in HFrEF, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ).

Clinical outcomes of empagliflozin

Researchers reported that empagliflozin compared with placebo reduced the primary outcome of CV death or HF hospitalization regardless of baseline KCCQ clinical summary score (CSS) tertile:

  • HR for KCCQ-CSS of less than 62.5 = 0.83; 95% CI, 0.68-1.02;
  • HR for KCCQ-CSS of 62.6 to 85.4 = 0.74; 95% CI, 0.58-0.94; and
  • HR for KCCQ-CSS of 85.4 or more = 0.61; 95% CI, 0.46-0.82; P for trend = .1.

Results were similar for baseline KCCQ total symptom scores (TSS) and KCCQ overall summary scores (OSS).

Health-related quality of life outcomes

At 3, 8 and 12 months, empagliflozin improved KCCQ-CSS (by 1.94, 1.35 and 1.61 points, respectively), KCCQ-TSS (by 2.52, 1.64 and 1.69 points, respectively) and KCCQ-OSS (by 1.77, 1.3 and 1.52 points, respectively) compared with placebo, the researchers wrote.

Butler and colleagues found that, at each time point, patients on empagliflozin were more likely to improve KCCQ-CSS and less likely to experience deterioration (P for all < .05).

At 3 months, the likelihood of a 5-point or greater improvement (OR = 1.2; 95% CI, 1.05-1.37), a 10-point or greater improvement (OR = 1.26; 95% CI, 1.1-1.44) and a 15-point or greater improvement (OR = 1.29; 95% CI, 1.12-1.48) in KCCQ-CSS was higher for the empagliflozin group compared with placebo. The likelihood of a 5-point or greater deterioration was also lower for the empagliflozin group compared with placebo (OR = 0.75; 95% CI, 0.64-0.87; P for all < .05).

At 8 and 12 months, the likelihood of improvement in KCCQ-CSS was higher for the empagliflozin group and the likelihood of deterioration was lower for the empagliflozin group compared with placebo (P for all < .05).

“Empagliflozin significantly improved cardiovascular outcomes across the range of baseline KCCQ-23 domains and improved health status in patients with HFrEF,” the researchers wrote. “Treatment with empagliflozin was accompanied by a higher likelihood of improvement and a lower likelihood of deterioration in health status. The highly concordant findings on patient-reported health status in the EMPEROR-Reduced and DAPA-HF trials support a role for SGLT2 inhibitors as a part of foundational treatment of HFrEF.”