Clinical characteristics and treatment patterns of new users of dapagliflozin for heart failure with reduced ejection fraction: an observational study programme across 12 countries (EVOLUTION HF)
Key result
Real-world dapagliflozin initiation in HFrEF faces prolonged delays despite a low ~5% annual discontinuation rate.
- n=1,736
Why the study?
Adoption of new therapies is historically slow despite clinical trial evidence, and real-world treatment profiles of patients initiating dapagliflozin for HFrEF remain scarce.
Key Points
- The aim is to describe clinical characteristics and treatment patterns among new users of dapagliflozin for heart failure with reduced ejection fraction.
- Prospective, observational study across 12 countries with 2170 enrolled patients.
- Electronic health records were analyzed to gather clinical characteristics.
- Interim analysis assessed 1736 patient profiles using descriptive statistics.
- At initiation, patients had an average age of 65-70 years with predominantly male and an ischaemic aetiology.
- Mean left ventricular ejection fraction was 29-32%, and hypertension and atrial fibrillation were common.
- Treatment discontinuation rates at 6 and 12 months were 5.22% and 4.66%, respectively.
Study Design
Type
Observational (n=1,736)
Multicenter
Yes
Structured PICO
P
Population
1,736 patients initiating dapagliflozin for heart failure with reduced ejection fraction (HFrEF) in routine clinical practice across 12 countries. Excluded: type 1 diabetes or prior SGLT-2i treatment. Mean age 65-70 years, 67-76% male, 35-56% ischemic etiology, NYHA class II 52-85%.
I
Intervention
Dapagliflozin initiation in routine clinical practice
O
Outcome
Clinical characteristics and treatment patterns (including time to initiation and discontinuation rates)
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Despite the paradigm-shifting trial results for novel GDMTs, early initiation of novel GDMTs in real-world settings remains a clinical challenge.”
ABAnkeet BhattCardiologist, Kaiser Permanente San Francisco Medical Center
“The findings in EVOLUTION HF highlight the need for well-powered implementation studies enrolling diverse patients across race, sex, socioeconomic class, and care setting which specifically evaluate various implementation strategies.”
Implication
Real-world data from 12 European countries shows a substantial delay of 23-52 months in initiating dapagliflozin after HFrEF diagnosis, though discontinuation rates remain low.
Abstract
Background Clinical trials have shown that dapagliflozin, a sodium–glucose cotransporter-2 inhibitor (SGLT-2i), reduces cardiovascular mortality and worsening heart failure (HF). Adoption of new therapies has historically been slow despite robust evidence. Furthermore, treatment profiles of patients in real-world settings are scarce. Purpose EVOLUTION HF is a multinational study programme that aims to describe clinical characteristics and treatment patterns among patients initiating dapagliflozin for HF with reduced ejection fraction (HFrEF) in routine clinical practice. Methods The EVOLUTION HF primary data study programme consists of prospective, observational, descriptive studies of new users of dapagliflozin for HFrEF in 12 countries (Italy, Portugal, UK and the Central and Eastern Europe and Baltic [CEEBA] region [Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania and Slovenia]). Patients with type 1 diabetes or prior SGLT-2i treatment were excluded. Clinical characteristics were obtained from electronic health records. A total of 2170/2555 (85%) patients were enrolled from November 2021 to November 2023; 1736 patient profiles were assessed using descriptive statistics in this interim analysis. Results In total, 256, 228, 125 and 1127 new dapagliflozin users were analysed from Italy, Portugal, the UK and the CEEBA region, respectively (Table 1). Across the 12 countries, mean patient age in the studies was 65–70 years. Patients were predominantly male (67–76%) and generally had HF with an ischaemic aetiology (35–56%) and New York Heart Association functional class II (52–85%). Mean left ventricular ejection fraction in the studies was 29–32% and estimated glomerular filtration rate was 61–77 mL/min/1.73m². Hypertension and atrial fibrillation were common comorbidities. Mean time between HF diagnosis and dapagliflozin initiation in the studies was 23–52 months. Background therapy included angiotensin receptor-neprilysin inhibitors (36–72%), angiotensin receptor blockers (4–12%) and angiotensin-converting enzyme inhibitors (9–33%). At 6 and 12 months after dapagliflozin initiation, respectively, treatment discontinuation rates across the CEEBA region were 5.22% (59/1131) and 4.66% (50/1072). Conclusions The EVOLUTION HF primary data study programme provides novel insights into clinical characteristics and treatment patterns in patients with HFrEF initiating dapagliflozin in real-world practice across a broad European population. At dapagliflozin initiation, a large proportion of patients were receiving other HF therapeutics, suggesting dapagliflozin is one of the later therapies to be initiated. Indeed, this study identified a substantial delay (23–52 months) in dapagliflozin initiation following HF diagnosis. Treatment discontinuation rates following dapagliflozin initiation were also low, reinforcing the findings of the EVOLUTION HF secondary data studies.
Discussion
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Cite This Study
Rosano et al. (2024) conducted an observational in Heart failure with reduced ejection fraction (HFrEF) (n=1,736). Dapagliflozin was evaluated on Treatment discontinuation rate at 12 months. Real-world initiation of dapagliflozin in patients with HFrEF was delayed by 23-52 months following diagnosis, with low treatment discontinuation rates of 4.66% at 12 months.