RESUMO
Background@#The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry. @*Methods@#A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY). @*Results@#Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY). @*Conclusion@#There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.
RESUMO
Purpose@#Triage tools play a vital role in classifying the severity of children in emergency departments (EDs). We investigated the association between the Korean Triage and Acuity Scale (KTAS) and severity of dyspnea in the ED. @*Methods@#We conducted a retrospective study of children aged 3-14 years with dyspnea who visited the ED from January 2015 through December 2021. They were divided into severe (KTAS level 1-3) and non-severe (KTAS level 4-5) groups. Between the groups, we compared the clinical characteristics, including age, sex, associated symptoms, vital signs, route of visit, treatment at ED, and outcomes. @*Results@#Among a total of 468 children with dyspnea, 267 and 201 were assigned to the severe and non-severe groups, respectively. The severe group had higher frequencies of fever (21.7% vs. 13.9%; P = 0.031), cough (53.2% vs. 43.3%; P = 0.034), systemic steroids (42.3% vs. 25.9%; P < 0.001), intravenous fluids (47.6% vs. 25.4%; P < 0.001), oxygen therapy (16.5% vs. 6.5%; P = 0.001), inotropics (4.1% vs. 1.0%; P = 0.042), and hospitalization (24.7% vs. 11.9%; P = 0.002). The severe group also showed a higher mean heart rate, respiratory rate, and temperature, and lower mean oxygen saturation (all Ps < 0.001). Among these findings, fever, heart rate, respiratory rate, temperature, intravenous fluids, oxygen therapy, inotropics, and hospitalization remained significantly different between the groups after defining the severe group as a KTAS level 1-2. @*Conclusion@#This study shows the association between KTAS and severity of dyspnea in the ED. Therefore, KTAS may reflect not only the initial clinical conditions but also emergency measures and outcomes in children with dyspnea who visit EDs.