Sketch trial limitations
More than half of patients had type 2 diabetes (56%) and atrial fibrillation (53%).
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The average duration of heart failure was about 3 years, with a median LVEF of 60%. Investigators randomized 324 patients (mean age of about 70 years 57% women) with NYHA class II to IV symptoms, an LVEF of 45% or higher, elevated natriuretic peptides, a requirement for diuretic therapy, and at least one of the following enrichment factors: a recent HF hospitalization or urgent HF visit requiring IV diuretics, elevated filling pressure by right or left heart catheterization, or structural heart disease on an echocardiogram. PRESERVED-HF, conducted at 26 US centers, was designed to address this question. Recently reported results of the EMPEROR-Preserved trial demonstrate that empagliflozin lowers the risk of CV death/hospitalization for heart failure in HFpEF, but the impact of SGLT2 inhibition on symptoms, physical limitations, and exercise function in this population has remained unclear. SGLT2 inhibitors, including dapagliflozin and empagliflozin (Jardiance Boehringer Ingelheim/Eli Lilly), were initially developed to treat type 2 diabetes but have since been shown to reduce CV death and worsening heart failure and to improve symptoms and physical limitations in HFrEF. Relieving symptoms and physical limitations in this group are key goals of management, he said, pointing out that “there has been a wide range of therapies that have been tested in this disease condition on these particular outcomes with minimal impact, highlighting a critical unmet clinical need.” Patients with a preserved ejection fraction make up more than half of all heart failure cases now, with the prevalence of HFpEF increasing in the United States, Kosiborod noted. Kosiborod said the larger effect observed here compared with other trials of SGLT2 inhibitors likely has to do with the types of patients enrolled in PRESERVED-HF, who had a much lower baseline KCCQ score, heavier symptom burden, and greater functional impairment than patients in other studies.
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This, in our opinion, should have implications for clinical practice.”Īfter the presentation, Milton Packer, MD (Baylor Heart and Vascular Institute, Houston, TX), addressed Kosiborod from the audience, calling the results “really impressive” and “unprecedented,” pointing out that “this is the largest KCCQ benefit ever reported in any trial with a drug for HFrEF or HFpEF.” The results, which are in press in Nature Medicine, complement those from large trials focused on clinical outcomes, he said, “and collectively support the use of SGLT2 inhibitors as a new treatment option in HFpEF, which is a morbid condition with few therapeutic options. “PRESERVED-HF, to our knowledge, is the first trial to demonstrate that SGLT2 inhibitor dapagliflozin significantly improves symptoms, physical limitations, and 6-minute walking distance in patients with HFpEF,” Kosiborod said. “The effect was large, clinically meaningful, and statistically significant,” he said, noting that the finding was consistent across key subgroups defined by diabetes status, baseline LVEF, and other variables. Dapagliflozin (Farxiga AstraZeneca) eases symptoms and physical limitations among patients who have heart failure with preserved ejection fraction (HFpEF) within a relatively short time period, the PRESERVED-HF trial shows, adding to recent evidence supporting the benefits of sodium-glucose cotransporter 2 (SGLT2) inhibition in this difficult-to-treat population.Īfter 12 weeks of treatment, improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score was 5.8 points greater in patients treated with dapagliflozin versus placebo ( P = 0.001), Mikhail Kosiborod, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), reported Sunday at the Heart Failure Society of America 2021 meeting in Denver, CO.