A cost-effectiveness analysis of empagliflozin for heart failure patients across the full spectrum of ejection fraction in Spain: combined results of the EMPEROR-Preserved and EMPEROR-Reduced trials.

BACKGROUND: Heart failure (HF) is a chronic condition with considerable clinical burden for patients and economic burden for healthcare systems. Treatment for HF is typically based on ejection fraction (EF) phenotype. The cost-effectiveness of empagliflozin + standard of care (SoC) compared to SoC has been examined for HF phenotypes below or above 40% EF separately, but not across the full spectrum of EF in Spain. METHODS: The results of two preexisting, validated, and published phenotype-specific Markov cohort models were combined using a population-weighted approach, reflecting the incidence of each phenotype in the total HF population in Spain. A probabilistic sensitivity analysis was performed by sampling each model's probabilistic results. RESULTS: Empagliflozin + SoC compared to SoC resulted in increased life-years (LYs) (6.48 vs. 6.35), quality-adjusted LYs (QALYs) (4.80 vs. 4.63), and healthcare costs (€19,090 vs. €18,246), over a lifetime time horizon for the combined HF population in Spain. The incremental cost-effectiveness ratio (ICER) was €5,089/QALY. All subgroup, scenario, and probabilistic ICERs were consistently below €10,000/QALY. CONCLUSIONS: Empagliflozin is the first treatment with established efficacy and cost-effectiveness for HF patients across EF from the perspective of healthcare payers in Spain. Empagliflozin also proved to be cost-effective for all subgroups of patients included in the analysis.

Assessment of medical management in Coronary Type 2 Diabetic patients with previous percutaneous coronary intervention in Spain: A retrospective analysis of electronic health records using Natural Language Processing.

INTRODUCTION AND OBJECTIVES: Patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD) previously revascularized with percutaneous coronary intervention (PCI) are at high risk of recurrent ischemic events. We aimed to provide real-world insights into the clinical characteristics and management of this clinical population, excluding patients with a history of myocardial infarction (MI) or stroke, using Natural Language Processing (NLP) technology. METHODS: This is a multicenter, retrospective study based on the secondary use of 2014-2018 real-world data captured in the Electronic Health Records (EHRs) of 1,579 patients (0.72% of the T2D population analyzed; n = 217,632 patients) from 12 representative hospitals in Spain. To access the unstructured clinical information in EHRs, we used the EHRead® technology, based on NLP and machine learning. Major adverse cardiovascular events (MACE) were considered: MI, ischemic stroke, urgent coronary revascularization, and hospitalization due to unstable angina. The association between MACE rates and the variables included in this study was evaluated following univariate and multivariate approaches. RESULTS: Most patients were male (72.13%), with a mean age of 70.5±10 years. Regarding T2D, most patients were non-insulin-dependent T2D (61.75%) with high prevalence of comorbidities. The median (Q1-Q3) duration of follow-up was 1.2 (0.3-4.5) years. Overall, 35.66% of patients suffered from at least one MACE during follow up. Using a Cox Proportional Hazards regression model analysis, several independent factors were associated with MACE during follow up: CAD duration (p < 0.001), COPD/Asthma (p = 0.021), heart valve disease (p = 0.031), multivessel disease (p = 0.005), insulin treatment (p < 0.001), statins treatment (p < 0.001), and clopidogrel treatment (p = 0.039). CONCLUSIONS: Our results showed high rates of MACE in a large real-world series of PCI-revascularized patients with T2D and CAD with no history of MI or stroke. These data represent a potential opportunity to improve the clinical management of these patients.

Incidence and costs of cardiovascular events in Spanish patients with type 2 diabetes mellitus: a comparison with general population, 2015.

INTRODUCTION: Cardiovascular (CV) disease affects a high percentage of patients with type 2 diabetes mellitus (T2DM), especially in the hospital setting, impacting on mortality, complications, quality of life and use of health resources. The aim of this study was to estimate the incidence, mean length of hospital stay (LOHS) and costs attributable to hospital admissions due to CV events in patients with T2DM versus patients without diabetes mellitus (non-DM) in Spain. RESEARCH DESIGN AND METHODS: Retrospective observational study based on the Spanish National Hospital Discharge Database for 2015. Hospital admissions for patients aged ≥35 years with a diagnosis of CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, unstable angina, heart failure and revascularization were evaluated. The International Classification of Diseases, Ninth Revision (250.x0 or 250.x2) coding was used to classify records of patients with T2DM. For each CV complication, the hospital discharges of the two groups, T2DM and non-DM, were precisely matched and the number of hospital discharges, patients, LOHS and mean cost were quantified. Additional analyses assessed the robustness of the results. RESULTS: Of the 276 925 hospital discharges analyzed, 34.71% corresponded to patients with T2DM. A higher incidence was observed in all the CV complications studied in the T2DM population, with a relative risk exceeding 2 in all cases. The mean LOHS (days) was longer in the T2DM versus the non-DM group for: non-fatal AMI (7.63 vs 7.02, p<0.001), unstable angina (5.11 vs 4.78, p=0.009) and revascularization (7.96 vs 7.57, p<0.001). The mean cost per hospital discharge was higher in the T2DM versus the non-DM group for non-fatal AMI (€6891 vs €6876, p=0.029) and unstable angina (€3386 vs €3304, p<0.001). CONCLUSIONS: Patients with T2DM had a higher incidence and number of hospital admissions per patient due to CV events versus the non-DM population. This generates a significant clinical and economic burden given the longer admission stay and higher costs associated with some of these complications.

[Intermediate coronary care units: rationale, infrastructure, equipment, and referral criteria]. / Unidades coronarias de cuidados intermedios: base racional, infraestructura, equipamiento e indicaciones de ingreso.

The Spanish Working Group on Coronary Artery Disease of Spanish Society of Cardiology has considered to be necessary the development of this document on the need, structure and organization of Intermediate Cardiac Care Units (ICCU). Acute coronary syndrome registries show that an important percentage of patients receive a suboptimal care, due to an inadequate management of health resources or absence of them. Intermediate cardiac care units arise to solve these challenges and to manage in an efficient way these expensive and limited resources. Their aims are: a) to provide each patient the level of care required; b) to optimize the structural, technical and human resources, and c) to make easier continuous care and care gradient. As a result, ICCU should be established as an essential part of the cardiology department aim to cardiac patients requiring monitoring and medical care superior to those available in a regular cardiac ward but whose risk does not justify the technical and human costs of a Coronary Unit. This document describes the structure (equipment, human resources, management) required to reach the goals previously reported and includes recommendations about indications of admission in a ICCU. These indications include: a) patients with NSTE-ACS with intermediate or high risk but hemodynamically stable, and b) low risk STEAMI or high risk STEAMI stabilized after an initial admission at the Coronary Unit. The admission of some patients undergoing invasive procedures or suffering non-coronary acute cardiac diseases, is also considered.