Dapagliflozin for attenuating early anthracycline-associated cardiac changes (DAPA-AIC): a randomized, double-blind, placebo-controlled trial

Q: What are the key findings of this study?

Dapagliflozin 10 mg once daily resulted in a higher adjusted 4-month LVEF compared to placebo (adjusted mean difference, 2.40 percentage points) in patients receiving anthracycline-based chemotherapy.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Newly diagnosed malignancies scheduled to receive anthracycline-based chemotherapy (n=94). Intervention: Dapagliflozin vs. Matching placebo. Primary outcome: 4-month left ventricular ejection fraction (LVEF) adjusted for baseline LVEF (MD 2.40 percentage points, 95% CI 1.25-3.54, p=<0.001).

Q: What does this research mean for the field?

Dapagliflozin attenuates early anthracycline-associated declines in left ventricular ejection fraction and adverse cardiac biomarker changes. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate whether dapagliflozin prevents early cardiac functional decline and biomarker alterations during anthracycline-based chemotherapy.

Hakar Abdulkareem Saeed; Nidhal A. K. Mohammed Ali; Ramadhan T. Othman

doi:10.1080/20565623.2026.2741250

October 6, 2026Future Science OAOpen Access

Dapagliflozin for attenuating early anthracycline-associated cardiac changes (DAPA-AIC): a randomized, double-blind, placebo-controlled trial

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Key result

Dapagliflozin preserves LVEF by ~2.4 percentage points vs. placebo during anthracycline chemotherapy.

MD +2.40 pts
95% CI 1.25-3.54
P<0.001
n=94

Figures

Graphical abstract published by Future Science OA — Graphical abstract · Published by Future Science OA · CC BY-NC

Why the study?

It was unknown whether dapagliflozin attenuates early cardiac functional and biomarker changes during anthracycline-based chemotherapy.

Does dapagliflozin 10 mg once daily prevent early cardiac functional and biomarker decline in adults receiving anthracycline-based chemotherapy?

Key Points

To evaluate whether dapagliflozin prevents early cardiac functional decline and biomarker alterations during anthracycline-based chemotherapy.
Randomized, double-blind, placebo-controlled phase II trial (NCT06888505) allocating 94 adults receiving anthracyclines 1:1 to oral dapagliflozin 10 mg daily (n = 47) or placebo (n = 47) for 4 months.
The primary endpoint was 4-month left ventricular ejection fraction (LVEF) analyzed by complete-case ANCOVA (n = 90; 45 per arm) adjusted for baseline LVEF, along with secondary biomarker and transmitral filling assessments.
Dapagliflozin resulted in a significantly higher adjusted 4-month LVEF than placebo (adjusted mean difference, 2.40 percentage points; 95% CI, 1.25–3.54; p < 0.001; change in LVEF: +0.13 ± 2.28 vs −2.31 ± 3.27 percentage points).
Exploratory transmitral E/A ratio decline was attenuated in the dapagliflozin group compared to placebo (Δ −0.002 ± 0.094 vs Δ −0.053 ± 0.124; between-group mean difference, −0.051; 95% CI, −0.097 to −0.005; nominal p = 0.030).
Galectin-3 decreased with dapagliflozin and increased with placebo (−57.5 ± 134.8 pg/mL vs +59.6 ± 117.3 pg/mL; p < 0.001), while NT-proBNP had a smaller median increase (+4 pg/mL vs +16 pg/mL; p = 0.004).

Study Design

Type

RCT (n=94)

Blinding

Double-blind

Randomization

1:1 ratio using a computer-generated allocation sequence with randomly varying block sizes

Multicenter

No

Structured PICO

Does dapagliflozin 10 mg once daily prevent early cardiac functional and biomarker decline in adults receiving anthracycline-based chemotherapy?

P

Population

94 adults (mean age 47, 89% female) with newly diagnosed malignancies scheduled for anthracycline chemotherapy and baseline LVEF ≥50%, followed for 4 months.

I

Intervention

Dapagliflozin 10 mg orally once daily, initiated within 48 hours of the first anthracycline administration and continued for 4 months.

C

Comparator

Matching visually identical placebo administered orally once daily for 4 months. Both groups received standard oncologic care including anthracycline-containing chemotherapy regimens.

O

Outcome

4-month left ventricular ejection fraction (LVEF), measured using the biplane Simpson method from apical four- and two-chamber views, analyzed using analysis of covariance (ANCOVA) adjusted for baseline LVEF.surrogate

Main Result

Mean Difference: 2.4 (95% CI 1.25–3.54)

Absolute Event Rate: 60.78% vs 58.47%

p-value: p=<0.001

Dapagliflozin administered concomitantly with anthracycline-based chemotherapy significantly attenuated early subclinical decline in left ventricular ejection fraction and improved cardiac biomarker profiles over a 4-month period.

Limitations

Single-center design and modest sample size
Short 4-month follow-up period
Predominance of female participants with breast cancer
Advanced echocardiographic indices such as GLS were not systematically available
Echocardiographic measurements were not adjudicated by an independent core laboratory
Small sample size
Short treatment duration
Single-center exploratory design
Not powered to establish safety or detect uncommon adverse events

Key expert perspectives

Captured external expert commentary on this paper, strongest first. Original sources are linked where available.

RJRishabh JainMedical oncologist, AIIMS Delhi

“Dapagliflozin may attenuate early anthracycline-associated cardiac dysfunction, but it is not ready for routine prophylactic use yet. A very interesting signal for the future of cardio-oncology prevention.”

All India Institute of Medical Sciences, New DelhiSocial Media

Implication

Supports testing dapagliflozin to prevent anthracycline cardiotoxicity; extends SGLT2 inhibitor evidence to chemotherapy recipients.

Abstract

Aims To evaluate whether dapagliflozin attenuates early cardiac functional and biomarker changes during anthracycline-based chemotherapy.Materials & Methods In this randomized, double-blind, placebo-controlled phase II trial, 94 adults were assigned 1:1 to dapagliflozin 10 mg once daily or placebo for 4 months; 90 completed follow-up. The primary endpoint was 4-month left ventricular ejection fraction (LVEF), analyzed using analysis of covariance (ANCOVA) adjusted for baseline LVEF. Secondary and exploratory outcomes included cardiac biomarkers and the early-to-late transmitral flow velocity ratio (E/A ratio).Results Dapagliflozin was associated with higher adjusted 4-month LVEF than placebo (adjusted mean difference, 2.40 percentage points; 95% confidence interval [CI], 1.25–3.54; p < 0.001). Change in LVEF was +0.13 ± 2.28 versus −2.31 ± 3.27 percentage points, respectively. E/A ratio decline was attenuated (p = 0.030). Galectin-3 decreased with dapagliflozin but increased with placebo (p < 0.001), while N-terminal pro-B-type natriuretic peptide (NT-proBNP) increased less (p = 0.004). No major safety signal was observed during the 4-month follow-up.Conclusions Dapagliflozin was associated with attenuation of early anthracycline-associated cardiac functional and biomarker changes. Larger, longer trials are needed to determine clinical benefit.Clinical trial registration www.clinicaltrials.gov identifier is NCT06888505. Retrospectively registered.

Discussion

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Cite This Study

Saeed et al. (2026) conducted an RCT in Newly diagnosed malignancies scheduled to receive anthracycline-based chemotherapy (n=94). Dapagliflozin vs. Matching placebo was evaluated on 4-month left ventricular ejection fraction (LVEF) adjusted for baseline LVEF (MD 2.40 percentage points, 95% CI 1.25-3.54, p=<0.001). Dapagliflozin 10 mg once daily resulted in a higher adjusted 4-month LVEF compared to placebo (adjusted mean difference, 2.40 percentage points) in patients receiving anthracycline-based chemotherapy.

synapsesocial.com/papers/6ac74632947fe0d7c56432d6 https://doi.org/10.1080/20565623.2026.2741250

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Dapagliflozin for attenuating early anthracycline-associated cardiac changes (DAPA-AIC): a randomized, double-blind, placebo-controlled trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Key expert perspectives

Implication

Abstract

Discussion

Cite This Study

Dapagliflozin for attenuating early anthracycline-associated cardiac changes (DAPA-AIC): a randomized, double-blind, placebo-controlled trial

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Key expert perspectives

Implication

Abstract

Discussion

Cite This Study

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