Eligibility and Cost-Utility Analysis of Dapagliflozin in Patients with Heart Failure Across the Whole Spectrum of Ejection Fraction in South Korea.

BACKGROUND: The DAPA-HF and DELIVER trials demonstrated the clinical benefits of dapagliflozin in heart failure (HF) patients across the entire ejection fraction (EF) spectrum. However, further investigation is needed for the real-world application of dapagliflozin in HF patients. This study examines the proportion of real-world HF patients eligible for dapagliflozin and evaluates the cost-effectiveness of adding dapagliflozin to current HF therapy. METHODS: Data from the nationwide prospective registry, the Korean Acute Heart Failure (KorAHF) registry, were used to determine dapagliflozin eligibility based on the enrollment criteria of the DAPA-HF/DELIVER trials. A cost-utility analysis was conducted using a Markov model to assess the cost-effectiveness of dapagliflozin by comparing it to the standard of care. RESULTS: Out of 5178 KorAHF patients, 48.7% met the enrollment criteria of the DAPA-HF/DELIVER trials, while 89.5% met the label criteria (US Food and Drug Administration, European Medicines Agency, and Korean Ministry of Food and Drug Safety). Eligibility was highest among HF patients with preserved EF (55.3% vs. HF with mildly reduced EF and HF with reduced EF 46.4%). Dapagliflozin proved to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of 4557 US dollar (US$) per quality-adjusted life year, which falls below the US$18,182 willingness-to-pay threshold. The cost-effectiveness benefit was more pronounced in patients with a left ventricular EF (LVEF) ≤ 40% (ICER US$3279 for LVEF ≤ 40% vs. US$8383 for LVEF > 40%). CONCLUSIONS: Discrepancies in dapagliflozin eligibility were observed between real-world data and clinical trial results. The addition of dapagliflozin to HF therapy proved to be highly cost-effective across the entire EF spectrum.

Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea.

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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01389843.

Medical costs in patients with heart failure after acute heart failure events: one-year follow-up study.

AIMS: This study investigated annual medical costs using real-world data focusing on acute heart failure. METHODS: The data were retrospectively collected from six tertiary hospitals in South Korea. Overall, 330 patients who were hospitalized for acute heart failure between January 2011 and July 2012 were selected. Data were collected on their follow-up medical visits for 1 year, including medical costs incurred toward treatment. Those who died within the observational period or who had no records of follow-up visits were excluded. Annual per patient medical costs were estimated according to the type of medical services, and factors contributing to the costs using Gamma Generalized Linear Models (GLM) with log link were analyzed. RESULTS: On average, total annual medical costs for each patient were USD 6,199 (±9,675), with hospitalization accounting for 95% of the total expenses. Hospitalization cost USD 5,904 (±9,666) per patient. Those who are re-admitted have 88.5% higher medical expenditure than those who have not been re-admitted in 1 year, and patients using intensive care units have 19.6% higher expenditure than those who do not. When the number of hospital days increased by 1 day, medical expenses increased by 6.7%. LIMITATIONS: Outpatient drug costs were not included. There is a possibility that medical expenses for AHF may have been under-estimated. CONCLUSION: It was found that hospitalization resulted in substantial costs for treatment of heart failure in South Korea, especially in patients with an acute heart failure event. Prevention strategies and appropriate management programs that would reduce both frequency of hospitalization and length of stay for patients with the underlying risk of heart failure are needed.

Direct comparison of B-type natriuretic peptide and N-terminal pro-BNP for assessment of cardiac function in a large population of symptomatic patients.

BACKGROUNDS: B-type natriuretic peptide (BNP) and N-terminal pro-BNP (NTproBNP) levels showed frequent discrepancies in individual patients. OBJECTIVES: The aims were 1) to compare the abilities of BNP and NTproBNP for the detection of left ventricular systolic dysfunction (LVSD) or diastolic dysfunction (LVDD) in the symptomatic patients, and 2) to assess the direct correlation and its independent determinants between them. METHODS: 1032 patients with dyspnea underwent BNP and NTproBNP measurements simultaneously. 967/1032 (93.7%) patients underwent echocardiography. Using the receiver operation characteristic curve analyses for the detection of LVSD (EF<45%) or advanced LVDD, the area under the curves (AUC) of both biomarkers was compared according to age, gender, body mass index (BMI), hemoglobin (Hb), and glomerular filtration rate (eGFR). Using multiple regression analysis, the direct correlation and its independent determinants were identified between them. RESULTS: In the entire population, the AUCs of BNP and NTproBNP had no significant differences (LVSD: 0.909 vs. 0.893, p=0.20; advanced LVDD: 0.897 vs. 0.879, p=0.13). In patients with BMI<25, the AUCs of BNP were significantly higher than those of NTproBNP (LVSD: 0.897 vs. 0.869, p=0.03; advanced LVDD: 0.916 vs. 0.885, p=0.02). They had strong correlation (r=0.895, p<0.001) and LVEF, eGFR<60 ml/min, Hb<12 g/dl and use of diuretics were the independent determinants between them. CONCLUSION: BNP and NTproBNP displayed strong correlation and near-identical performances for the screening of cardiac dysfunction. However, LVEF, renal function, Hb and use of diuretics should be considered for clinical interpretation.

A serial ultrasound assessment of neoaneurysm following paclitaxel-eluting stent implantation.

We present a case of serial regression of aneurysm of coronary artery complicating paclitaxel-eluting Taxus stent implantation in the mid anterior descending artery evaluated by intravascular ultrasound in a 55-year-old woman.