

Forxiga is the first and only SGLT2i approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF).5


Forxiga is the first and only SGLT2i approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF).5
In patients with HFrEF (NYHA, class II-IV)# and eGFR ≥30 mL/min/1.73m², Forxiga has been shown to offer early efficacy†, quality-of-life improvement versus placebo and once-daily dosing with no uptitration.1,2,4,5*
DAPA HF Trial Overview
Hear Professor Mark Petrie, Professor of Cardiology at the University of Glasgow, discuss the the design and results of the DAPA-HF Trial.
Heart failure: a call to action
Professor Martin Cowie discusses strategies to improve
heart failure care in the UK.


In patients with HFrEF (NYHA, class II-IV)# and eGFR ≥30 mL/min/1.73m², Forxiga has been shown to offer early efficacy†, quality-of-life improvement versus placebo and once-daily dosing with no uptitration.1,2,4,5*
The Landmark DAPA-HF Trial1,6
DAPA-HF is the first heart failure (HFrEF) outcomes study with an SGLT2i. The trial enrolled 4744 patients with HFrEF (NYHA class II-IV)#, with and without T2D.


On top of standard of care
Forxiga reduces the risk of CV death or worsening HF1
Primary endpoint: Composite of CV death or worsening HF1*


Adapted from McMurray et al. 2019.
Significant Reductions in Each Component of the Primary Endpoint
On top of standard of care, Forxiga 10 mg achieved a statistically significant reduction in each component of the primary endpoint1


Adapted from McMurray et al. 2019.
Prespecified Subgroup Analysis of Patients With and Without T2D1,3
On top of standard of care, Forxiga demonstrated proven efficacy in patients with and without T2D.1,3


Adapted from Petrie et al. 2020.
On top of standard of care, Forxiga 10 mg
reduces the risk of all-cause mortality1‡


Adapted from McMurray et al. 2019.
Forxiga 10 mg has a Well-Established Safety Profile1,5,9
Over 8 years of experience since first approval in T2D5
The overall safety profile of dapagliflozin in patients with heart failure was consistent with the known safety profile of dapagliflozin1,5


When prescribing in patients with co-morbid symptomatic HFrEF and insufficiently controlled T2D5
Simple once-daily dosing††, no dose adjustment required based on renal function.


†† No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg5
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* In patients with symptomatic HFrEF in the DAPA-HF trial (N=4744; median follow-up 18.2 months; primary endpoint CV death or worsening HF*: Forxiga 16.3% vs. placebo 21.2% P<0.001).
† In a post-hoc analysis, risk reduction in CV death or worsening HF observed by 28 days with Forxiga vs. placebo: HR 0.51 (95% Cl, 0.28, 0.94) p=0.03
**Worsening HF is defined as hHF or urgent HF visit requiring IV therapy for HF.
‡Due to the hierarchical testing strategy, all-cause mortality was nominally significant.
§ Data on other adverse events were not routinely collected in view of the extensive previous collection of safety data regarding Forxiga.
¶ In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg
# Experience with dapagliflozin in NYHA class IV is limited.
†† A 5-point change in the KCCQ score was classed as clinically meaningful.
§§ Quality of life was measured by KCCQ-OSS which was a post hoc analysis.
‡‡ Patients received background standard drug and device therapy for HFrEF, in accordance with recognized guidelines.
ACEi, angiotensin-converting-enzyme inhibitor; AE, adverse event; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor–neprilysin inhibitor; ARR, absolute risk reduction; CI, confidence interval; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HR, hazard ratio; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; hHF, hospitalisation for heart failure; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NNT, number needed to treat; NYHA, New York Heart Association; RRR, relative risk reduction; SAE, serious adverse event; SGLT2i, sodium-glucose cotransporter 2 inhibitor; T2D, type 2 diabetes; UTI, urinary tract infection.
References:
1. McMurray JJV et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995-2008.
2. Sabatine MS et al. Timing of Onset of Clinical Benefit with Dapagliflozin in Patients with Heart Failure: An Analysis from DAPA-HF. Presented at: AHA Scientific Sessions; November 1 6-18, 2019; Philadelphia, PA.
3. Petrie MC et al. Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. JAMA. 2020;323:1353-1368.
4. Kosiborod MN et al. Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial. Circulation. 2020;141(2):90-99.
5. FORXIGA (dapagliflozin) 10 mg film‑coated tablets Summary of Product Characteristics. November 2020
6. McMurray JJV et al. A trial to evaluate the effect of the sodium-glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF). Eur J Heart Fail. 2019 May;21(5):665-675.
7. Docherty KF et al. Effects of dapagliflozin in DAPA-HF according to background heart failure therapy. Eur Heart J. 2020;41(25):2379-2392.
8. McMurray J. Presented at: ESC Congress; August 31-September 4, 2019; Paris, France.
9. McMurray JJV et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019;381(21):1995-2008 [Supplementary]
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