Dapagliflozin and New York Heart Association functional class in heart failure with mildly reduced or preserved ejection fraction: the DELIVER trial

Ostrominski, John W.; Vaduganathan, Muthiah; Claggett, Brian; Boer, Rudolf A. de; Desai, Akshay S; Dobreanu, Dan; Hernandez, Adrian F.; Inzucchi, Silvio E.; Jhund, Pardeep S.; Kosiborod, Mikhail; Lam, Carolyn S.P.; Langkilde, Anna Maria; Lindholm, Daniel; Martínez, Felipe A.; O’Meara, Eileen; Petersson, Magnus; Shah, Sanjiv J.; Thierer, Jorge; McMurray, John J.V.; Solomon, Scott D.

doi:10.1002/ejhf.2652

Cited by 26 publications

(31 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…For cardiovascular outcomes, this is apparent by nearly immediate separation of event curves, with prior analyses of both patients with EF ≤40% and >40% demonstrating statistically and clinically significant risk reduction apparent after only 12–18 days of therapy 8,9 . The current study by Ostrominski, together with prior data, extends this message to functional outcomes, with clinicians more likely to report improvement in patient NYHA class, and less likely to report deterioration, within 4 weeks of SGLT2i initiation 7,8 . Lastly, the absolute benefits of SGLT2i on patient‐reported health status are even greater among those with more severe baseline impairment 7 .…”

Section: Figuresupporting

confidence: 58%

“…In this issue of the Journal, Ostrominski et al 7 . present results from a secondary analysis of the DELIVER trial evaluating the clinical effects of dapagliflozin by baseline New York Heart Association (NYHA) functional class.…”

Section: Figurementioning

confidence: 99%

“…4,5 Apart from continued risks of death and hospitalization, the subset of patients with HFmrEF and HFpEF who remain very symptomatic and functionally limited represent a population in particular need of effective therapy. 5,6 In this issue of the Journal, Ostrominski et al 7 present results from a secondary analysis of the DELIVER trial evaluating the clinical effects of dapagliflozin by baseline New York Heart Association (NYHA) functional class. In total, 4713 (75%) of patients in DELIVER were classified as NYHA class II, whereas 1549 (25%) were classified as NYHA class III/IV.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Sodium–glucose cotransporter 2 inhibitors for heart failure with mildly reduced or preserved ejection fraction: time to deliver implementation

Greene

Fonarow

Butler

2022

European J of Heart Fail

View full text Add to dashboard Cite

Section: Figuresupporting

confidence: 58%

Section: Figurementioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Sodium–glucose cotransporter 2 inhibitors for heart failure with mildly reduced or preserved ejection fraction: time to deliver implementation

Greene

Fonarow

Butler

2022

European J of Heart Fail

View full text Add to dashboard Cite

“…Dapagliflozin consistently reduced the risk of the primary endpoint compared with placebo, irrespective of baseline NYHA class (HR 0.81 [95% CI 0.70–0.94] for NYHA class II versus HR 0.80 [95% CI 0.65–0.98] for NYHA class III/IV; interaction p = 0.921). Improvement in quality of life was more evident among those patients with more advanced symptoms (NYHA class III/IV) 21 …”

Section: Focus On Clinical Trialsmentioning

confidence: 95%

“…Improvement in quality of life was more evident among those patients with more advanced symptoms (NYHA class III/IV). 21 trial. In contrast, patients without HF hospitalization had a relatively stable eGFR trajectory.…”

mentioning

confidence: 99%

October 2022 at a glance: focus on clinical trials

Tomasoni

Adamo

Metra

2022

European J of Heart Fail

View full text Add to dashboard Cite

Assessment of biomarkers is a cornerstone of heart failure (HF) management. [1][2][3][4] A review from the Biomarkers Working Group of the Heart Failure Association summarizes the utility of biomarkers for defining and managing congestion on top of clinical evaluation, haemodynamics, and imaging. 5 The same group also reviewed the use of circulating biomarkers in clinical trials. They may be used as inclusion criteria, as surrogate endpoints, or as safety endpoints. 6 Focus on clinical trials SGLT2 inhibitorsSodium-glucose cotransporter 2 (SGLT2) inhibitors are recommended as foundational therapy for patients with HF and reduced ejection fraction (HFrEF) for their effects on mortality and HF hospitalizations. [7][8][9][10] They also improved quality of life in randomized controlled trials but their effects on exercise capacity, a measurement not changed by neurohormonal modulators, are less studied. 11 In the multicentre randomized double-blind DAPA-VO 2 trial, dapagliflozin, compared with placebo, significantly improved peak oxygen consumption at 1 and 3 months in stable patients with HFrEF. 12 Administration of SGLT2 inhibitors is associated with an initial decline in estimated glomerular filtration rate (eGFR). Changes in eGFR from randomization to week 4 were assessed in the EMPEROR-Reduced trial. On average, empagliflozin induced a leftward shift of the distribution of the initial eGFR changes, i.e. a greater decrease, of -2.5 ml/min/1.73 m 2 versus placebo in patients with HFrEF. 13 The initial mild decline in eGFR was not associated with a higher risk of HF, mortality, or kidney safety events. 13 Similarly, in the EMPULSE trial, including patients hospitalized for acute HF with an eGFR >20 ml/min/1.73 m 2 , empagliflozin caused an initial decline in eGFR of -2 ml/min/1.73 m 2 at day 15 compared to placebo that was no longer evident at day 90. The clinical benefit of empagliflozin was independent of baseline eGFR. 14 Liver dysfunction is a marker of more severe HF and an independent predictor of poor prognosis. 15 In the Dapagliflozin And Prevention of Adverse outcomes in Heart Failure (DAPA-HF) trial, patients with the highest bilirubin tertile had more severe HFrEF

show abstract

Cost‐utility analysis of add‐on dapagliflozin in heart failure with preserved or mildly reduced ejection fraction

Tang

Sang

2023

ESC Heart Failure

View full text Add to dashboard Cite

Aims The DELIVER study demonstrates a significant improvement in cardiovascular death or hospitalization for heart failure among heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF).Cost‐utility of the adjunct use of dapagliflozin to standard therapy among patients with HFpEF or HFmrEF remains unclear. Methods and results A five‐state Markov mode was constructed to project health and clinical outcomes of the adjunct use of dapagliflozin to standard therapy among 65‐year‐old patients with HFpEF or HFmrEF. A cost‐utility analysis was performed based on the DELIVER study and national statistical database. The cost and utility was inflated to 2022 by the usual discount rate of 5%. The primary outcomes were total cost and quality‐adjusted life‐years (QALYs) per patients as well as the incremental cost‐effectiveness ratio. Sensitivity analyses were also applied. Over a 15 year lifetime horizon, the average cost per patient was $7245.77 and $5407.55 in the dapagliflozin group and the standard group, along with an incremental cost of $1838.22. The average QALYs per patient was 6.00 QALYs and 5.84 QALYs in the dapagliflozin group and the standard group, along with an incremental QALYs of 0.15 QALYs, resulting in the incremental cost‐effectiveness ratio of $11 865.33/QALY, which was below the willingness‐to‐pay (WTP) of $12 652.5/QALY. The univariate sensitivity analysis indicated the cardiovascular death in both group was the most sensitive variable. Probability sensitivity analysis revealed that when the WTP thresholds were $12 652.5/QALY and $37 957.5/QALY, the probabilities of being cost‐effective with dapagliflozin as an add‐on were 54.6% and 71.6%, respectively. Conclusions From a public healthcare system perspective, the adjunct use of dapagliflozin to standard therapy among patients with HFpEF or HFmrEF generated advantages in cost‐effectiveness in China at a WTP of $12 652.5/QALY, which promoted the rational use of dapagliflozin for heart failure.

show abstract

Dapagliflozin and New York Heart Association functional class in heart failure with mildly reduced or preserved ejection fraction: the DELIVER trial

Cited by 26 publications

References 36 publications

Sodium–glucose cotransporter 2 inhibitors for heart failure with mildly reduced or preserved ejection fraction: time to deliver implementation

Sodium–glucose cotransporter 2 inhibitors for heart failure with mildly reduced or preserved ejection fraction: time to deliver implementation

October 2022 at a glance: focus on clinical trials

Cost‐utility analysis of add‐on dapagliflozin in heart failure with preserved or mildly reduced ejection fraction

Contact Info

Product

Resources

About