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. 2021 Dec 30;15(1):47. doi: 10.3390/ph15010047

Table 3.

Comparison of double-blind, randomized clinical trials on dapagliflozin and empagliflozin in Heart failure (HF).

Selected Clinical Trials on SGLT-2 Inhibitors in Heart Failure
FLOZIN DAPAGLIFLOZIN EMPAGLIFLOZIN
STUDY DAPA-HF [47] DELIEVER
[48]
EMPEROR-Reduced [44] EMPEROR-Preserved [49]
INCLUSION CRITERIA Patients of an age of at least 18 years, an ejection fraction of 40% or less, NYHA class II, III, or IV. Patients were required to have a plasma level of N-terminal pro–B-type natriuretic peptide (NT-proBNP) of at least 600 pg per millilitre (or ≥400 pg per millilitre if they had been hospitalized for heart failure within the previous 12 months). Patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-proBNP level of at least 900 pg per millilitre. Patients at 40 years of age or older, with an LVEF > 40%, evidence of structural heart disease and elevation in natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (≥600 pg/mL for patients in atrial fibrillation or flutter). Adults (≥18 years of age) who had chronic heart failure (functional class II, III, or IV) and
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    LVEF ≤30% and NT-proBNP ≥600 pg/mL (without AF) and ≥1200 pg/mL (with AF);

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    LVEF 31–35% and NT-proBNP ≥1000 pg/mL (without AF) and ≥2000 pg/mL (with AF);

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    LVEF 36–40% and NT-proBNP ≥2500 pg/mL (without AF) and ≥5000 pg/mL (with AF);

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    LVEF >40% and hospitalization for heart failure in past 12 mo and NT-proBNP ≥600 pg/mL (without AF) and ≥1200 pg/mL (with AF)

Patients with LVEF >40%, elevated N-terminal pro B-type
natriuretic peptide (NT-proBNP) concentrations (i.e., >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of heart failure hospitalization. NYHA II-IV.
NUMBER OF PATIENTS 4744 6263 3730 5988
DIABETIC STATUS Both diabetic and non-diabetic patients. Both diabetic and non-diabetic patients. Both diabetic and non-diabetic patients. Both diabetic and non-diabetic patients.
MEAN FOLLOW-UP TIME 18.2 months. Ongoing trial. 16 months. 26.2 months
PRIMARY ENDPOINT Worsening heart failure (urgent hospitalization or intravenous therapy) or death from cardiovascular causes. Cardiovascular death or worsening heart failure event (heart failure hospitalization or urgent HF visit). Adjudicated cardiovascular death or hospitalization for heart failure, analysed as the time to the first event. A composite of adjudicated cardiovascular (CV) death or hospitalization for HF.
PRIMARY ENDPOINT OCCURENCE The primary outcome occurred in 386 of 2368 patients (16.3%) in the dapagliflozin group and in 502 of 2375 patients (21.2%) in the placebo group
(HR: 0.74).
Ongoing trial Primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure: 0.75). A primary composite outcome event occurred in 415 patients (13.8%) in the empagliflozin group and in 511 patients (17.1%) in the placebo group, HR: 0.79.
DIABETIC VS. NON-DIABETIC GROUP Findings in patients with diabetes were similar to those in patients without diabetes. Ongoing trial The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The effects were consistent across prespecified subgroups, including in the presence or absence of diabetes at baseline.