Dapagliflozin use in routine management of heart failure with reduced ejection fraction: outcomes from the Bulgarian cohort of a large observational study (EVOLUTION-HF)

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Adults (≥18 years) with heart failure with reduced ejection fraction (LVEF ≤40%), newly prescribed dapagliflozin in routine clinical practice in Bulgaria (n=150). Intervention: Dapagliflozin. Primary outcome: Persistence on dapagliflozin treatment at 6 and 12 months after initiation (Discontinuation rate 4.65 per 100 patient-years, 95% CI 95% CI: 1.28-8.02).

Q: What does this research mean for the field?

Dapagliflozin shows a high persistence rate of 98% at 12 months in patients with heart failure with reduced ejection fraction in Bulgaria. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

I. Gruev; K. Bletzova; I. Deenichina; G. Goranov; Konstantin Gospodinov; G. Gyuzelev; M. Mihalev; S. Petranov; S. Yovev; Vasil Velchev

doi:10.3897/bgcardio.31.e178401

December 31, 2025Bulgarian CardiologyOpen Access

Dapagliflozin use in routine management of heart failure with reduced ejection fraction: outcomes from the Bulgarian cohort of a large observational study (EVOLUTION-HF)

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Key result

Dapagliflozin maintains ~97% one-year treatment persistence in patients with HFrEF.

Discontinuation rate 4.65 per 100 patient-years
95% CI: 1.28-8.02
n=150

Why the study?

The study was designed to describe the demographic and clinical characteristics of patients initiating dapagliflozin for HFrEF in routine clinical practice.

Key Points

To describe the baseline characteristics, treatment persistence, and real-world guideline-directed medical therapy patterns among patients initiating dapagliflozin for heart failure with reduced ejection fraction.
Conducted a prospective, non-interventional cohort study analyzing N=150 patients (mean age: 67 years, males 84%) enrolled across 10 study sites in Bulgaria between February 2022 and October 2022 as part of EVOLUTION-HF.
Collected baseline clinical characteristics 12 months prior to dapagliflozin initiation and prospectively recorded heart failure management according to routine clinical practice up to 12 months after initiation.
At initiation of dapagliflozin 10 mg/day, 69.3% of patients were treated with renin-angiotensin-aldosterone system (RAAS) inhibitors and 35.3% were receiving all four guideline-directed medical therapy (GDMT) drug classes.
Almost 98% of patients remained on dapagliflozin at 6 months and 12 months, with 7 (10.12%) total discontinuations throughout the study and a discontinuation rate of 4.65 per 100 patient-years (median time-to-discontinuation not reached).
One patient stopped dapagliflozin between baseline and 6 months and one between 6 and 12 months, while overall GDMT treatment patterns remained relatively stable over one year.

Study Design

Type

Observational (n=150)

Multicenter

Yes

Structured PICO

P

Population

150 adults (≥18 years) with confirmed HFrEF (LVEF ≤40%) newly prescribed dapagliflozin, mean age 67.14 years, 84% male, based in Bulgaria (10 sites). Key exclusion criteria: history of type 1 diabetes, prior treatment with dapagliflozin or other SGLT2 inhibitors, and previous use of dapagliflozin for indications other than HF.

I

Intervention

Dapagliflozin 10 mg oral once daily added to routine clinical practice/guideline-directed medical therapy for up to 12 months.

O

Outcome

Demographic and clinical data at baseline, dapagliflozin treatment patterns (including time to treatment interruptions and/or discontinuation at 6 and 12 months), and treatment patterns for other HF medication and glucose-lowering therapies.

Main Result

Effect estimate: Discontinuation rate 4.65 per 100 patient-years (95% CI 95% CI: 1.28-8.02)

In a real-world Bulgarian cohort of HFrEF patients, dapagliflozin showed high 12-month persistence (97.3%), but highlighted a significant gap in optimal GDMT adoption, with only 35.3% receiving all four foundational therapies.

Limitations

Observational design without randomization or control group
Data limited to Bulgarian cohort only
No direct efficacy or outcome comparison to placebo or other treatments
Limited safety data reported
Potential selection bias due to real-world setting

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Reassures clinicians on real-world dapagliflozin adherence in HFrEF; extends RCT evidence but highlights gaps in optimal GDMT uptake.

Abstract

Introduction: The EVOLUTION-HF is a prospective, multinational, real-world study designed to describe the demographic and clinical characteristics of patients initiating dapagliﬂ ozin for heart failure with reduced ejection fraction (HFrEF) in nine countries from the Central and Eastern Europe and Baltic Area. This manuscript presents the results of the Bulgarian cohort of the study. Methods: Enrolment period in Bulgaria was between February 2022 and October 2022, in 10 study sites. Demographic and clinical characteristics were collected at baseline (12 months before dapagliﬂ ozin initiation), and treatment for heart failure (HF), including guideline-directed treatment (GDMT) was collected prospectively until 12 months after dapagliﬂ ozin initiation. The HF treatment was administered as per routine clinical practice. Results: One hundred and ﬁ fty patients were included in the full analysis set (mean age: 67 years, males 84%). At the time of initiation of dapagliﬂ ozin 10 mg/day, 69.3% of patients had treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors and 35.3% all four GDMTs in HF. Almost 98% of patients remained on dapagliﬂ ozin at 6 months and 12 months. Seven (10.12%) dapagliﬂ ozin discontinuations were recorded throughout the study. The discontinuation rate of dapagliﬂ ozin was 4.65 per 100 patient-years and the median time-to-discontinuation was not reached. One patient stopped dapagliﬂ ozin between baseline and 6 month and between 6 month and 12 month-data collection, respectively. GDMT patterns were relatively stable over one year. Conclusion: A high rate of persistence of dapagliﬂ ozin was observed at 12-month follow-up after initiation for HFrEF. A substantial gap was noted related to GDMT strategy optimization, with only one third of patients receiving all four GDMT pillars. These results obtained in real-world practice in Bulgaria point to the unmet need for targeted efforts to improve GDMT adoption in patients with HFrEF.

Discussion

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Cite This Study

Gruev et al. (2025) conducted an observational in Adults (≥18 years) with heart failure with reduced ejection fraction (LVEF ≤40%), newly prescribed dapagliflozin in routine clinical practice in Bulgaria (n=150). Dapagliflozin was evaluated on Persistence on dapagliflozin treatment at 6 and 12 months after initiation (Discontinuation rate 4.65 per 100 patient-years, 95% CI 95% CI: 1.28-8.02). Dapagliflozin showed a high persistence with 97.3% of patients remaining on treatment at 12 months and a low discontinuation rate of 4.65 per 100 patient-years in Bulgarian patients with HFrEF.

synapsesocial.com/papers/69a1344fed1d949a99abe0a3 https://doi.org/10.3897/bgcardio.31.e178401

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Dapagliflozin use in routine management of heart failure with reduced ejection fraction: outcomes from the Bulgarian cohort of a large observational study (EVOLUTION-HF)

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Dapagliflozin use in routine management of heart failure with reduced ejection fraction: outcomes from the Bulgarian cohort of a large observational study (EVOLUTION-HF)

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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