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Dapagliflozin provides modest reduction in hospitalization for heart failure with LVEF greater than 40% (DELIVER)
Clinical Question
For patients with heart failure and a left ventricular ejection fraction greater than 40%, does dapagliflozin improve outcomes?
Bottom line
In patients with heart failure and LVEF greater than 40%, dapagliflozin 10 mg once daily reduces the need for hospitalization due to heart failure (NNT = 36 over 2.3 years to prevent one hospitalization) but had no significant effect on mortality. At US$500 per month for 27 months at an NNT of 36, the medication cost to prevent one hospitalization is $486,000. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (any)
Synopsis
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and like other drugs in this class has been shown to reduce cardiovascular mortality and hospitalizations in patients with heart failure and left ventricular ejection fraction (LVEF) of 40% or less. This industry-sponsored study identified 6263 patients, 40 years or older, with stabilized heart failure, an LVEF greater than 40%, and an elevated natriuretic peptide level. The patients were then randomized to receive dapagliflozin 10 mg once daily or placebo. The 2 groups were balanced at baseline, analysis was by intention to treat, and events were blindly adjudicated. The mean age of the patients was 72 years and 45% had diabetes mellitus. After a median follow-up of 2.3 years, the primary composite of cardiovascular death, hospitalization for heart failure, and urgent visit for heart failure was significantly lower in the dapagliflozin population (16.4% vs 19.5%; hazard ratio [HR] 0.82; 95% CI 0.73 - 0.92; number needed to treat [NNT] = 32 over 2.3 years). However, the only individual outcome that was significantly reduced was hospitalization for heart failure (10.5% vs 13.3%; HR 0.77; 0.67 - 0.89; NNT = 36 over 2.3 years). The rates of cardiovascular mortality (7.4% for dapagliflozin vs 8.3% for placebo) and all-cause mortality (15.9% vs 16.8%) were not significantly reduced. There were no important differences in adverse events, and the results were similar for patients with and without diabetes.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Dapagliflozin and heart failure.
Not many people can afford a drug so expensive.
dapagliflozin reduces admission to hospital for heart failur
From a hospitalisation point of view, the results are less than stellar. The tidbit about reduced ER visits is somewhat intriguing and makes one wonder if for patients with EF greater than 40% that there may be an improvement in quality of life.
Dapagliflozin provides modest reduction in hospitalization f
At $486,000 to prevent one hospitalization over 2.3 years one wonders how much the cost of that hospitalization was and what the clinical course of the patient was. Seems the most cost effective approach might be to avoid taking the drug and pay for the hospitalization.
surprenant qu'il n'y ait pas…
surprenant qu'il n'y ait pas de différence dans la survenue d'effets secondaires considérant le risque d'infection urinaire et d'infection fongique. Quoiqu'il en soit, le peu de bénéfice au niveau des hospitalisations fait que le coût par rapport aux bénéfices est trop élevé (une hospitalisation coûte moins de 486000$)
dapaglifozin and chf
decreases hospitaliztions due to CHF