New EMPEROR-Preserved data show HF benefits regardless of diabetes status
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Empagliflozin reduced risk for heart failure hospitalization similarly in people with and without type 2 diabetes and delayed the need for insulin initiation in those with diabetes or prediabetes, data from EMPEROR-Preserved show.
In new analyses comparing participants with and without type 2 diabetes, researchers also found empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) slowed the rate of decline in kidney function irrespective of diabetes status, with a slightly greater benefit observed among people with diabetes, according to Gerasimos Filippatos, MD, FESC, FHFA, FACC, professor of cardiology at the National and Kapodistrian University of Athens in Greece.
“Decisions to use empagliflozin for the treatment of heart failure (HF) in patients with HF with preserved ejection fraction (HFpEF) should not be influenced by glycemic status of individual patients,” Filippatos said during a virtual presentation at the European Association for the Study of Diabetes annual meeting.
As Healio previously reported, EMPEROR-Preserved trial data demonstrated empagliflozin improved clinical outcomes for patients with HFpEF — the first agent to be shown to do so. The trial included 5,988 participants with NYHA class II to IV HF and an EF above 40%, randomly assigned empagliflozin 10 mg daily or placebo. Within the cohort, mean age was 72 years and 49% had type 2 diabetes.
During a median follow-up of 26.2 months, the primary outcome of cardiovascular death or hospitalization for HF occurred in 13.8% of the empagliflozin group compared with 17.1% of the placebo group (HR = 0.79; 95% CI, 0.69-0.9), driven by HF hospitalization (HR = 0.71; 95% CI, 0.6-0.83). The results did not differ according to EF (41% to 49%, 50% to 59% or 60% or more), with a P value for trend of .21. The data were published in The New England Journal of Medicine in August.
Compared with participants without diabetes, trial participants with type 2 diabetes were more likely to have a history of HF hospitalization in the past 12 months, have atrial fibrillation and hypertension, Filippatos said. Despite a greater likelihood of CVD history, empagliflozin reduced first HF hospitalization or CV death similarly among patients with diabetes (HR = 0.79; 95% CI, 0.67-0.94) and without diabetes (HR = 0.78; 95% CI, 0.64-0.95), with a P value for interaction of .9224, Filippatos said. Similarly, the key secondary outcome of total (first plus recurrent) HF hospitalization was similarly reduced for participants with diabetes (HR = 0.73; 95% CI, 0.57-0.94) and without diabetes (HR = 0.74; 95% CI, 0.56-0.97). Baseline HbA1c did not influence the effect of empagliflozin on CV death or HF hospitalization, Filippatos said.
Benefits beyond HF
Assessing selected prespecified kidney endpoints in EMPEROR-Preserved, Filippatos said empagliflozin slowed the rate of decline in estimated glomerular filtration rate, with mean increases of 1.77 mL/min/1.73 m2 per year for participants with diabetes and 0.98 mL/min/1.73 m2 for those without diabetes.
Empagliflozin also delayed the need for sustained insulin initiation among participants with diabetes or prediabetes compared with placebo, with an HR of 0.69 (95% CI, 0.49-0.98), Filippatos said.
‘Focus on implementation’
The mechanism or mechanisms behind empagliflozin’s HF benefit are still not completely understood, and debate continues about how to best identify reduced vs. preserved ejection fraction, Anna Norhammar, MD, PhD, associate professor in cardiology, senior consultant in cardiology, clinical physiology and internal medicine at Karolinska Institutet in Stockholm, said during a commentary after the data presentation. There is also a lack of long-term data on the effects of SGLT2 inhibition. Despite those points, overwhelmingly positive HF data for people with type 2 diabetes suggest clinicians should “focus on implementation,” she said.
“This is a game changer for three categories of patients: for the HF patient, the type 2 diabetes patient and for health care providers,” Norhammar said. “This will simplify treatment choices in type 2 diabetes.”
Data also showed empagliflozin was safe and well tolerated among participants with type 2 diabetes, with very few participants experiencing diabetic ketoacidosis or hypoglycemia and no observed increased risk for amputations, Norhammar said.
“There are now several scientific reasons to treat type 2 diabetes patients with an SGLT2 inhibitor and very few reasons not to,” Norhammar said.
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Filippatos G. EMPEROR Preserved study. Presented at: European Association for the Study of Diabetes Annual Meeting; Sept. 27-Oct. 1, 2021 (virtual meeting).
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