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).

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.

What question did this study set out to answer?

To evaluate the effects of dapagliflozin on heart failure with reduced ejection fraction in Bulgarian patients.

February 27, 2026Open 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)

Key Result

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.

Key Points

To evaluate the effects of dapagliflozin on heart failure with reduced ejection fraction in Bulgarian patients.
Conducted a prospective cohort study in Bulgaria from February to October 2022.
Collected demographic and clinical characteristics at baseline and after 12 months of dapagliflozin treatment.
Analyzed adherence to guideline-directed treatments in heart failure patients.
Of 150 patients, 98% remained on dapagliflozin at both 6 and 12 months.
About 69.3% of patients were on RAAS inhibitors at dapagliflozin initiation.
Only 35.3% received all four guideline-directed treatments for heart failure.

Study Design

Type

Observational (n=150)

Multicenter

Yes

Structured PICO

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.

Intervention

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

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.

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.

Main Result

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

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

Abstract

Introduction: The EVOLUTION-HF is a prospective, multinational, real-world study designed to describe the demographic and clinical characteristics of patients initiating dapagli 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 dapagli ozin initiation), and treatment for heart failure (HF), including guideline-directed treatment (GDMT) was collected prospectively until 12 months after dapagli ozin initiation. The HF treatment was administered as per routine clinical practice. Results: One hundred and fty patients were included in the full analysis set (mean age: 67 years, males 84%). At the time of initiation of dapagli 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 dapagli ozin at 6 months and 12 months. Seven (10.12%) dapagli ozin discontinuations were recorded throughout the study. The discontinuation rate of dapagli ozin was 4.65 per 100 patient-years and the median time-to-discontinuation was not reached. One patient stopped dapagli 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 dapagli 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.

Bookmark

View Full Paper

Cite This Study

Gruev et al. (Wed,) conducted a 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/https://doi.org/10.3897/bgcardio.31.e178401

Bookmark

View Full Paper