4CPS-155 Dapaglifozin real-world data in patients with heart failure compared to clinical trials: a retrospective observational study

<h3>Background and Importance</h3> Heart failure (HF) affects 2–3% of adults, leading to significant morbidity and mortality. Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was recently approved by the European Medicines Agency (EMA) for treating symptomatic chronic HF with preserved or reduced left ventricular ejection fraction (LVEF), based on the DAPA-HF and DELIVER trials. <h3>Aim and Objectives</h3> To assess the real-world effectiveness of dapagliflozin in reducing heart failure-related hospitalisations and mortality. <h3>Material and Methods</h3> This retrospective observational study analysed data from 50 patients with HF who began dapagliflozin treatment. Key parameters collected included demographics (sex, age), clinical data at initiation (serum creatinine, estimated glomerular filtration rate (eGFR), LVEF reduced (&lt;40%) or preserved (&gt;40%) NT-proBNP levels), comorbidities (diabetes mellitus, hypertension), and hospitalisation/mortality outcomes based on LVEF categories. Statistical analyses were conducted to compare hospitalisation and mortality rates with clinical trials. <h3>Results</h3> Of the 50 patients, 41 (82%) were male, with a mean age of 78.5 years. Key clinical parameters were: serum creatinine (1.22 mg/dL), eGFR (83.02 mL/min/1.73 m²), reduced LVEF (26%), preserved LVEF (74%), and NT-proBNP (6811.24 pg/mL). Comorbidities included diabetes (86%) and hypertension (92%). Hospitalisation rates were higher in patients with reduced LVEF (76%) compared to those with preserved LVEF (46%). Mortality from HF was 6% in the reduced LVEF group and 10% in the preserved group. <h3>Conclusion and Relevance</h3> Hospitalisation and mortality rates were significantly higher in this study than in the DAPA-HF (hospitalisation 9.7%, mortality 9.6%) and DELIVER trials (hospitalisation 16.4%). Factors contributing to these discrepancies include the older mean age of patients (78.5 vs. 66.2 in DAPA-HF and 72 in DELIVER) and higher comorbidity rates, particularly diabetes (86% vs. 42% in DAPA-HF and 45% in DELIVER). This suggests that real-world patients are often more heterogeneous and complex than those in randomised trials, highlighting the importance of age, comorbidity burden, and frailty in evaluating treatment effectiveness. Limitations of the study include its observational nature, a small sample size, and the fact that included patients did not meet the same criteria as those in pivotal trials, which may have influenced the observed outcomes. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest