Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial

Cox, Zachary L.; Collins, Sean P.; Aaron, Mark F.; Hernandez, Gabriel A.; McRae, Amy; Davidson, Beth Towery; Fowler, Mike; Lindsell, Christopher J.; Harrell, Frank E.; Jenkins, Cathy A.; Kampe, Christina J.; Miller, Karen F.; Stubblefield, William B; Lindenfeld, JoAnn

doi:10.1016/j.ahj.2020.10.071

Cited by 65 publications

(61 citation statements)

References 45 publications

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“…Similar trials targeting hospitalized patients with AHF are DICTATE‐AHF 43 and DAPA ACT HF‐TIMI 68 44 . However, the DICTATE‐AHF randomizes only patients with T2D within 24 h, and continues treatment until discharge 43 . Importantly, DICTATE‐AHF is an open‐label study comparing dapagliflozin to usual care.…”

Section: Discussionmentioning

confidence: 99%

“… 9 , 10 , 17 In both the DAPA‐HF and EMPEROR‐Reduced trials, there was an early benefit in reducing CV death or HHF, observed within days of randomization. Similar trials targeting hospitalized patients with AHF are DICTATE‐AHF 43 and DAPA ACT HF‐TIMI 68. 44 However, the DICTATE‐AHF randomizes only patients with T2D within 24 h, and continues treatment until discharge.…”

Section: Discussionmentioning

confidence: 99%

“…44 However, the DICTATE‐AHF randomizes only patients with T2D within 24 h, and continues treatment until discharge. 43 Importantly, DICTATE‐AHF is an open‐label study comparing dapagliflozin to usual care. The DAPA ACT HF‐TIMI 68 is currently enrolling patients with HFrEF (LVEF ≤40%) both with and without T2D, but excludes patients with HFpEF.…”

Section: Discussionmentioning

confidence: 99%

“…44 However, the DICTATE-AHF randomizes only patients with T2D within 24 h, and continues treatment until discharge. 43…”

Section: Methodsmentioning

confidence: 99%

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Sodium–glucose co‐transporter 2 inhibition in patients hospitalized for acute decompensated heart failure: rationale for and design of the EMPULSE trial

Tromp

Ponikowski

Salsali

et al. 2021

European J of Heart Fail

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Treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors improves outcomes in patients with chronic heart failure (HF) with reduced ejection fraction. There is limited experience with the in-hospital initiation of SGLT2 inhibitors in patients with acute HF (AHF) with or without diabetes. EMPULSE is designed to assess the clinical benefit and safety of the SGLT2 inhibitor empagliflozin compared with placebo in patients hospitalized with AHF.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…44 However, the DICTATE-AHF randomizes only patients with T2D within 24 h, and continues treatment until discharge. 43…”

Section: Methodsmentioning

confidence: 99%

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Sodium–glucose co‐transporter 2 inhibition in patients hospitalized for acute decompensated heart failure: rationale for and design of the EMPULSE trial

Tromp

Ponikowski

Salsali

et al. 2021

European J of Heart Fail

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“…(118) Prospective trials of acetazolamide and dapagliflozin early in ADHF are ongoing that will better inform this question. (118,119) While SGLT2i and acetazolamide will increase diuretic response in patients with CRS, available data indicates the magnitude of diuretic response is substantially less than strategies that target the loop of Henle and distal nephron. One advantage of SGLT2i as a diuretic adjuvant is that it has a dual benefit as a chronic medication to improve outcomes such as death and rehospitalization.…”

Section: Proximal Tubular Diureticsmentioning

confidence: 99%

Classic and Novel Mechanisms of Diuretic Resistance in Cardiorenal Syndrome

2022

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Despite the incompletely understood multiple etiologies and underlying mechanisms, cardiorenal syndrome is characterized by decreased glomerular filtration and sodium avidity. The underlying level of renal sodium avidity is of primary importance in driving a congested heart failure phenotype and ultimately determining the response to diuretic therapy. Historically, mechanisms of kidney sodium avidity and resultant diuretic resistance were primarily extrapolated to cardiorenal syndrome from non-heart failure populations, yet the mechanisms appear to differ between these populations. Recent literature in acute decompensated heart failure has refuted several classically accepted diuretic resistance mechanisms and reshaped how we conceptualize diuretic resistance mechanisms in cardiorenal syndrome. Herein, we propose an anatomically based categorization of diuretic resistance mechanisms, to establish the relative importance of specific transporters and translate findings toward therapeutic strategies. Within this categorical structure, we discuss classical and novel mechanisms of diuretic resistance.

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Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction

Tavares,

Azevedo,

Rea-Neto

et al. 2024

JAMA

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ImportanceSodium-glucose cotransporter 2 (SGLT-2) inhibitors improve outcomes in patients with type 2 diabetes, heart failure, and chronic kidney disease, but their effect on outcomes of critically ill patients with organ failure is unknown.ObjectiveTo determine whether the addition of dapagliflozin, an SGLT-2 inhibitor, to standard intensive care unit (ICU) care improves outcomes in a critically ill population with acute organ dysfunction.Design, Setting, and ParticipantsMulticenter, randomized, open-label, clinical trial conducted at 22 ICUs in Brazil. Participants with unplanned ICU admission and presenting with at least 1 organ dysfunction (respiratory, cardiovascular, or kidney) were enrolled between November 22, 2022, and August 30, 2023, with follow-up through September 27, 2023.InterventionParticipants were randomized to 10 mg of dapagliflozin (intervention, n = 248) plus standard care or to standard care alone (control, n = 259) for up to 14 days or until ICU discharge, whichever occurred first.Main Outcomes and MeasuresThe primary outcome was a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and ICU length of stay through 28 days, analyzed using the win ratio method. Secondary outcomes included the individual components of the hierarchical outcome, duration of organ support–free days, ICU, and hospital stay, assessed using bayesian regression models.ResultsAmong 507 randomized participants (mean age, 63.9 [SD, 15] years; 46.9%, women), 39.6% had an ICU admission due to suspected infection. The median time from ICU admission to randomization was 1 day (IQR, 0-1). The win ratio for dapagliflozin for the primary outcome was 1.01 (95% CI, 0.90 to 1.13; P = .89). Among all secondary outcomes, the highest probability of benefit found was 0.90 for dapagliflozin regarding use of kidney replacement therapy among 27 patients (10.9%) in the dapagliflozin group vs 39 (15.1%) in the control group.Conclusion and RelevanceThe addition of dapagliflozin to standard care for critically ill patients and acute organ dysfunction did not improve clinical outcomes; however, confidence intervals were wide and could not exclude relevant benefits or harms for dapagliflozin.Trial RegistrationClinicalTrials.gov Identifier: NCT05558098

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Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial

Cited by 65 publications

References 45 publications

Sodium–glucose co‐transporter 2 inhibition in patients hospitalized for acute decompensated heart failure: rationale for and design of the EMPULSE trial

Sodium–glucose co‐transporter 2 inhibition in patients hospitalized for acute decompensated heart failure: rationale for and design of the EMPULSE trial

Classic and Novel Mechanisms of Diuretic Resistance in Cardiorenal Syndrome

Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction

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