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Our landmark DAPA-HF trial investigated the efficacy and safety of dapagliflozin in the treatment of HFrEF (LVEF≤ 40%). Dapagliflozin demonstrated a clinically meaningful improvement in HF symptoms compared with placebo1,2
There was a reduction in the composite of worsening HF or CV death vs. placebo, in patients who took dapagliflozin2
The DELIVER trial investigated the efficacy and safety of dapagliflozin in patients with LVEF>40%3
Sodium-glucose co-transporter-2 inhibitors (SGLT-2i), like dapagliflozin, are now recommended by the European Society of Cardiology (ESC) as an option for first-line treatment for symptomatic heart failure across the range of ejection fractions
Type of HF | HFrEF | HFmrEF | HFpEF**
| |
|---|---|---|---|---|
| Criteria | 1 | Symptoms ± signs* | Symptoms ± signs* | Symptoms ± signs* |
| 2 | LVEF ≤40% | LVEF 41–49%† | LVEF ≥50% | |
© ESC 2023
**Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides‡
*Signs may not be present in the early stages of HF (especially in HFpEF) and in optimally treated patients. †For the diagnosis of HFmrEF, the presence of other evidence of structural heart disease (e.g., increased left atrial size, LV hypertrophy, or echocardiographic measures of impaired LV filling) makes the diagnosis more likely. ‡For the diagnosis of HFpEF, the greater the number of abnormalities present, the higher the likelihood of HFpEF.
people in the UK have HF5
people are diagnosed with HF annually in the UK5
of patients with HF present with >3 co-morbidities, including diabetes, CKD and AF6
patients with HF are readmitted within 30 days of hospital admission7
in patients with HF is ~50%, which increases significantly after each HF readmission8
for ~1 million bed days per year in the NHS9
of total National Health Service (NHS) expenditure is attributed to the treatment of patients with HF, with 60–70% related to costs of hospitalisation10
Explore the current guidelines and treatment recommendations for heart failure (HF)
In national and international guidelines, dapagliflozin is recommended for the treatment of eligible patients with Heart Failure3,11-15
National Institute for Health and Care Excellence (NICE) recommend and Scottish Medicines Consortium (SMC) accept use of dapagliflozin for the treatment of eligible patients with symptomatic chronic heart failure11,12
Dapagliflozin is recommended as an option for treating symptomatic chronic HFrEF in adults, only if it is used as an add-on to optimised standard of care with:
Start treatment of symptomatic HFrEF with dapagliflozin on the advice of a HF specialist. Monitoring should be done by the most appropriate healthcare professional
These recommendations are not intended to affect treatment with dapagliflozin that was started in the National Health Service (NHS) before this guidance was published.
People receiving treatment outside of these recommendations may continue with their treatment, without changes being made to the funding arrangements put in place for them prior to these guidelines being published, until they and their NHS clinician consider it appropriate to stop
Dapagliflozin is recommended, within its marketing authorisation, as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults13
SMC have accepted use of dapagliflozin (Forxiga) in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction
In a randomised, double-blind, phase III study, dapagliflozin demonstrated a significant reduction in the composite outcome of hospitalisation for heart failure, urgent heart failure visit and cardiovascular death compared with placebo in patients with heart failure with reduced ejection fraction receiving current standard of care.
Heart failure treatment was optimised and stable for at least 4 weeks before study enrolment and, unless contraindicated or not tolerated, included an ACE inhibitor or ARB or sacubitril/valsartan and betablocker, and if considered appropriate by the patient’s treating physician, a MRA.
FORXIGA has been accepted for use within NHS Scotland, by the SMC, in adults for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) >40%14
ESC 2021 HF guidelines:15
2023 Focused update of 2021 ESC HF guidelines:4
Adapted from ESC 2021 and 2023
* Class of recommendations.
† Level of evidence.
‡ This recommendation is based on the reduction of the primary composite endpoint used in the EMPEROR-Preserved and DELIVER trials and in a meta-analysis. However, it should be noted that there was a significant reduction only in HF hospitalisations and no reduction in CV death.
§ For HFrEF (≤40%): ARNI/ACEi/ARB, Beta-blocker, MRA, and SGLT2i are all Class I, Level A recommendations (ESC 2021; ESC Focused Update 2023).
¶ For HFmrEF (41–49%): SGLT2i therapy is Class I, Level A (ESC 2023). ACEi/ARB/ARNI, Beta-blocker, and MRA remain Class IIb.
‖ For HFpEF (≥50%): SGLT2i therapy is Class I, Level A (ESC 2023). Other therapies are supportive (e.g., diuretics for symptom relief, comorbidity management).
DAPA-HF was the first study to investigate the use of a sodium-glucose co-transporter-2 inhibitor (SGLT-2i) in patients with heart failure (HF), with or without type 2 diabetes (T2D)1,2
DELIVER was the largest trial to date to evaluate patients with heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF).1,3
DAPA-HF was an international, multicentre, randomised, double-blind, placebo-controlled study in patients with heart failure with reduced ejection fraction (HFrEF), regardless of the presence of T2D, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care.
The DELIVER trial was a phase 3, international,multicentre, double-blind, randomised, controlled trial in which patients with chronic heart failure and a left ventricular ejection fraction of more than 40% received dapagliflozin or matching placebo, in addition to their usual therapy.
*Experience with dapagliflozin in NYHA class IV is limited
† Worsening HF was defined as either an unplanned hospitalisation or an urgent HF visit requiring intravenous (IV) therapy for HF
‡ Patients received background standard drug and device therapy for HFrEF, in accordance with recognised guidelines. Standard drug therapy included an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or sacubitril-valsartan plus a beta blocker, unless contraindicated or resulted in unacceptable side effects. Use of an aldosterone receptor antagonist was encouraged1,2
*This list is not exhaustive, please refer to the supplementary appendix for the full list of key exclusion criteria
Primary endpoint: A composite of CV death or worsening HF (an episode of worsening HF was either an unplanned hospitalisation or an urgent HF visit requiring intravenous [IV] therapy for HF)2
Adapted from McMurray et al. 20192
Dapagliflozin reduced the risk of the composite endpoint of CV death or worsening heart failure. All components of the composite outcome favoured treatment with dapagliflozin compared with placebo2
A post-hoc analysis showed that risk reduction was seen within the initial 28 days of dapagliflozin treatment, this impact was also long-lasting as it persisted throughout the study which has a median follow-up of 18.2 months2,18
Secondary endpoint: All-cause mortality1,2
*Due to the hierarchical testing strategy, all-cause mortality was nominally significant.
Adapted from McMurray et al. 20192
On top of standard of care, treatment with dapagliflozin resulted in a clinically meaningful improvement in HF symptoms1,2
*Measured by the change from baseline at Month 8 in the KCCQ-TSS (win ratio 1.18; 95% CI: 1.11-1.26; p<0.0001).1,2 Symptom improvement was assessed by the KCCQ-TSS, which quantifies HF symptom frequency and severity, including fatigue, peripheral oedema, dyspnoea and orthopnoea.1,2
**In DAPA-HF, 4443 patients had available KCCQ data19,20
A ≥5-point change in the KCCQ score was classed as clinically meaningful1,2
Understand key safety considerations about the use of dapagliflozin.
ACE, angiotensin converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin receptor blockers; ARNI, angiotensin receptor-neprilysin inhibitors; ARR, absolute risk reduction; CI, confidence interval; CKD, chronic kidney disease; CV, cardiovascular; DAPA-HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DELIVER, Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure; ESC, European Society of Cardiology; eGFR, estimated glomerular filtration rate; GDMT, guideline-directed medical therapy; HF, heart failure; HFA-ESC, Heart Failure Association of the ESC; HFmrEF, heart failure with mildly-reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; hHF, hospitalisation for heart failure; HR, hazard ratio; IV, intravascular; KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire-Total symptom score; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonists; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; NNT, number needed to treat; NT-proBNP, N-terminal pro–B-type natriuretic peptide; NYHA, New York Heart Association; RRR, relative risk reduction; SGLT2i, Sodium-glucose Cotransporter-2 inhibitor; SMC, Scottish Medicines Consortium; T2D, type 2 diabetes.
GB-64438 | September 2025
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