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

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.