Real-world evidence with dapagliflozin in heart failure with reduced ejection fraction in Central Eastern Europe and the Baltic region (EVOLUTION-HF CEE-BA Study).

introductionSodium-glucose cotransporter 2 inhibitors (SGLT2i) are currently recommended as one of the four pillars of treatment in heart failure (HF) with reduced ejection fraction (HFrEF). Following the approval of dapagliflozin in 2020, real-world data are relevant for the medical community and payers. This study aimed to characterize the patient population with dapagliflozin initiated for HFrEF in clinical practice in 9 countries from Central Eastern Europe and the Baltic Area (CEE-BA).

methodsEVOLUTION-HF CEE-BA is a multicentre, multi-country, observational, longitudinal study conducted in 102 centres in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovenia. All treatment decisions were at the discretion of the patient's healthcare providers, based on the locally approved product information and routine clinical practice. Patients with type 1 diabetes, prior treatment with dapagliflozin or other SGLT2i, and initiation of dapagliflozin outside the approved HFrEF indication were excluded. The baseline period covered 12 months prior to dapagliflozin initiation, with prospective follow-up continuing up to 12 months or until loss to follow-up, death, or study discontinuation, whichever occurred first. Descriptive statistics and Kaplan-Meier methods were used.

resultsA total of 1131 patients with HFrEF were included in the full analysis set. Ischaemic aetiology was present in 52% of patients. The mean left ventricular ejection fraction was 32%. The most frequent comorbidities were atrial fibrillation (46%), type 2 diabetes (37%), and chronic kidney disease (29%). At the time of dapagliflozin initiation, 93% of patients received any combination of a renin-angiotensin-aldosterone system inhibitor (RAASi), beta-blocker (BB), or mineralocorticoid receptor antagonists (MRA). Of all patients, 60% received concomitantly all three classes plus dapagliflozin for their HFrEF. Except for dapagliflozin, which was administered as 10 mg/day, optimal doses were recorded for 14% for any RAASi, 17% for BB, and 25% for MRA. At 6- and 12-month follow-up, maintenance of dapagliflozin treatment was recorded in 95% and 96% of patients, respectively. The real-world median time to discontinuation of dapagliflozin has not been reached. The percentage of patients receiving all four classes recommended in HFrEF remained stable over the study period. Adverse events were reported spontaneously, as in routine clinical practice in each centre.

conclusionThis large non-interventional study provides a contemporary perspective of the treatments used in HFrEF over 1-year follow-up. Despite high dapagliflozin persistence rates, a low proportion of patients received complete guideline-directed medical therapy in optimal doses. Improvement of HF management decisions across the CEE-BA region is warranted.