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INTRODUCTION AND OBJECTIVES: This real-world study-the first of its kind in a Spanish population-aimed to explore severe risk for cardiovascular events and all-cause death following exacerbations in a large cohort of patients with chronic obstructive pulmonary disease (COPD). METHODS: We included individuals with a COPD diagnosis code between 2014 and 2018 from the BIG-PAC health care claims database. The primary outcome was a composite of a first severe cardiovascular event (acute coronary syndrome, heart failure decompensation, cerebral ischemia, arrhythmia) or all-cause death following inclusion in the cohort. Time-dependent Cox proportional hazards models estimated HRs for associations between exposed time periods (1-7, 8-14, 15-30, 31-180, 181-365, and >365 days) following an exacerbation of any severity, and following moderate or severe exacerbations separately (vs unexposed time before a first exacerbation following cohort inclusion). RESULTS: During a median follow-up of 3.03 years, 18 901 of 24 393 patients (77.5%) experienced ≥ 1 moderate/severe exacerbation, and 8741 (35.8%) experienced the primary outcome. The risk of a severe cardiovascular event increased following moderate/severe COPD exacerbation onset vs the unexposed period, with rates being most increased during the first 1 to 7 days following exacerbation onset (HR, 10.10; 95%CI, 9.29-10.97) and remaining increased >365 days after exacerbation onset (HR, 1.65; 95%CI, 1.49-1.82). CONCLUSIONS: The risk of severe cardiovascular events or death increased following moderate/severe exacerbation onset, illustrating the need for proactive multidisciplinary care of patients with COPD to prevent exacerbations and address other cardiovascular risk factors.
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Humanos , Estratificación Térmica , Insuficiencia Renal Crónica , Portador Sano , Hipertensión , Diabetes Mellitus , Dislipidemias , EspañaRESUMEN
BACKGROUND: Patients with atrial fibrillation (AF) and heart failure (HF) have a high risk of thromboembolism and other outcomes and anticoagulation is recommended. HYPOTHESIS: This study was aimed to explore the risk factors associated with HF worsening in patients with AF and HF taking rivaroxaban in Spain. METHODS: Multicenter, prospective, observational study that included adults with AF and chronic HF, receiving rivaroxaban ≥4 months before entering. HF worsening was defined as first hospitalization or emergency visit because of HF exacerbation. RESULTS: A total of 672 patients from 71 Spanish centers were recruited, of whom 658 (97.9%) were included in the safety analysis and 552 (82.1%) in the per protocol analysis. At baseline, mean age was 73.7 ± 10.9 years, 64.9% were male, CHA2 DS2 -VASc was 4.1 ± 1.5, HAS-BLED was 1.6 ± 0.9% and 51.3% had HF with preserved ejection fraction. After 24 months of follow-up, 24.9% of patients developed HF worsening, 11.6% died, 2.9% had a thromboembolic event, 3.1% a major bleeding, 0.5% an intracranial bleeding and no patient had a fatal hemorrhage. Older age, the history of chronic obstructive pulmonary disease, the previous use of vitamin K antagonists, and restrictive or infiltrative cardiomyopathies, were independently associated with HF worsening. Only 6.9% of patients permanently discontinued rivaroxaban treatment. CONCLUSIONS: Approximately one out of four patients with HF and AF treated with rivaroxaban developed a HF worsening episode after 2 years of follow-up. The identification of those factors that increase the risk of HF worsening could be helpful in the comprehensive management of this population.
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Fibrilación Atrial , Insuficiencia Cardíaca , Accidente Cerebrovascular , Tromboembolia , Adulto , Humanos , Masculino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Rivaroxabán/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Estudios Prospectivos , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Tromboembolia/epidemiología , Tromboembolia/etiología , Tromboembolia/prevención & control , Progresión de la Enfermedad , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/epidemiologíaRESUMEN
BACKGROUND: Heart failure (HF) and atrial fibrillation (AF) are common and coexistent conditions. HYPOTHESIS: To investigate the adverse events and mortality risk factors in patients with AF and HF treated with rivaroxaban in Spain. METHODS: Multicenter, prospective and observational study with a follow-up of 2 years, that included adults, with a diagnosis of nonvalvular AF and chronic HF, anticoagulated with rivaroxaban at least 4 months before being enrolled. RESULTS: A total of 672 patients from 71 Spanish centers were recruited, of whom 658 (97.9%) were included in the safety analysis and 552 (82.1%) in the per protocol analysis. At baseline, the mean age was 73.7 ± 10.9 years, 65.9% were male, 51.3% had HF with preserved ejection fraction and 58.7% were on New York Heart Association functional class II. CHA2 DS2 -VASc was 4.1 ± 1.5. During the follow-up, 11.6% of patients died and around one-quarter of patients were hospitalized or visited the emergency department, being HF worsening/progression the main cause (51.1%), with a 2.9% of thromboembolic events and 2.0% of acute coronary syndromes. Major bleeding occurred in 3.1% of patients, with 0.5% experiencing intracranial bleeding but no fatalities. Compliance with HF treatment was associated with a lower risk of death (hazard ratio: 0.092; 95% confidence interval: 0.03-0.31). CONCLUSIONS: Among patients with HF and AF anticoagulated with rivaroxaban, incidences of thromboembolic or hemorrhagic complications were low. The most important factor for improving survival was compliance with HF drugs, what strengths the need for early treatment with HF disease-modifying therapy and anticoagulation.
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Fibrilación Atrial , Insuficiencia Cardíaca , Accidente Cerebrovascular , Tromboembolia , Adulto , Humanos , Masculino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/diagnóstico , Rivaroxabán/efectos adversos , Anticoagulantes/efectos adversos , Estudios Prospectivos , Tromboembolia/epidemiología , Tromboembolia/etiología , Tromboembolia/prevención & control , Factores de Riesgo , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/tratamiento farmacológico , Accidente Cerebrovascular/etiologíaRESUMEN
AIMS: To determine the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during seven years of follow-up. METHODS: Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD between 2013 and 2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart-failure (HF), chronic-kidney disease (CKD), myocardial-infarction (MI), stroke or peripheral-artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs. Descriptive analyses and Cox model were applied to the data. RESULTS: 26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N=4974) developed a first CVKD manifestation during the seven years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N=2214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (95% CI: 1.8-3.4) and 1.8 (95% CI: 1.4-2.3)], respectively. The cumulative costs per patient of HF (50,942.80) and CKD (48,979.20) were higher than MI (47,343.20) and stroke (47,070.30) and similar to PAD (51,240.00) vs. 13,098.90 in patients who did not develop CVKD, p<0.001. CONCLUSIONS: In T2DM patients, HF and CKD were the first most common manifestations and had higher mortality and re-hospitalisation rates. HF and CKD were associated with the highest resource use and costs for the Spanish National-Health-System.
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Diabetes Mellitus Tipo 2 , Insuficiencia Cardíaca , Infarto del Miocardio , Insuficiencia Renal Crónica , Accidente Cerebrovascular , Adolescente , Adulto , Anciano , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/epidemiología , Humanos , Infarto del Miocardio/epidemiología , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Estudios Retrospectivos , España/epidemiología , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/epidemiologíaRESUMEN
Iron deficiency (ID) is a comorbid condition frequently seen in patients with heart failure (HF). Iron has an important role in the transport of oxygen, and is also essential for skeletal and cardiac muscle, which depend on iron for oxygen storage and cellular energy production. Thus, ID per se, even without anaemia, can be harmful. In patients with HF, ID is associated with a poorer quality of life (QoL) and exercise capacity, and a higher risk of hospitalisations and mortality, even in the absence of anaemia. Despite its negative clinical consequences, ID remains under-recognised. However, it is easily diagnosed and managed, and the recently revised 2021 European Society of Cardiology (ESC) guidelines on HF provide specific recommendations for its diagnosis and treatment. Prospective randomised controlled trials in patients with symptomatic HF with reduced ejection fraction (HFrEF) show that correction of ID using intravenous iron (principally ferric carboxymaltose [FCM]) provides improvements in symptoms of HF, exercise capacity and QoL, and a recent trial demonstrated that FCM therapy following hospitalisation due to acute decompensated HF reduced the risk of subsequent HF hospitalisations. This review provides a summary of the epidemiology and pathophysiology of ID in HFrEF, and practical guidance on screening, diagnosing, and treating ID.
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Objectives: To assess mortality and cardiovascular and renal outcomes among patients with chronic kidney disease (CKD) (primary objective), with a particular focus on heart failure (HF) risk following diagnosis of CKD (secondary objective) in Spain. Methods: We conducted an observational study comprising cross-sectional and longitudinal retrospective analyses using secondary data from electronic health records. For the primary objective, adults with prevalent CKD [estimated glomerular filtration rate (eGFR) <60 or ≥60 mL/min/1.73 m2 with a urine albumin:creatinine ratio (UACR) ≥30 mg/g at the index date (1 January 2017)] were included. For the secondary objective, adults with incident CKD in 2017 were enrolled. Results: In the prevalent population, 46 786 patients with CKD without HF [75.8 ± 14.4 years, eGFR 51.4 ± 10.1 mL/min/1.73 m2; 75.1% on renin-angiotensin system inhibitors (RASis)] and 8391 with CKD and HF (79.4 ± 10.9 years, eGFR 46.4 ± 9.8 mL/min/1.73 m2) were included. In the prevalent population, the risk of all-cause death {hazard ratio [HR] 1.107 [95% confidence interval (CI) 1.064-1.153]}, HF hospitalization [HR 1.439 (95% CI 1.387-1.493)] and UACR progression [HR 1.323 (95% CI 1.182-1.481)] was greater in those patients with CKD and HF versus CKD only. For the incident population, 1594 patients with CKD without HF and 727 with CKD and HF were included. Within 24 months from the CKD diagnosis (with/without HF at baseline), 6.5% of patients developed their first HF hospitalization. Although 60.7% were taking RASis, only 3.4% were at maximal doses and among diabetics, 1.3% were taking sodium-glucose cotransporter-2 inhibitors. Conclusions: The presence of HF among CKD patients markedly increases the risk of outcomes. CKD patients have a high risk of HF, which could be partially related to insufficient treatment.
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AIMS: Non-ischaemic dilated cardiomyopathy (NIDCM) is characterized by left ventricular (LV) chamber enlargement and systolic dysfunction in the absence of coronary artery disease. Left ventricular reverse remodelling (LVRR) is the ability of a dilated ventricle to restore its normal size, shape and function. We sought to determine the frequency, clinical predictors and prognostic implications of LVRR, in a cohort of heart failure (HF) patients with NIDCM. METHODS: We conducted a multicentre observational, retrospective cohort study of patients with NIDCM, with prospective serial echocardiography evaluations. LVRR was defined as an increase of ≥15% in left ventricular ejection fraction (LVEF) or as a LVEF increase ≥ 10% plus reduction of LV end-systolic diameter index ≥ 20%. We used multivariable logistic regression analyses to identify the baseline clinical predictors of LVRR and evaluate the prognostic impact of LVRR. RESULTS: LVRR was achieved in 42.5% of 527 patients with NIDCM during the first year of follow-up (median LVEF 49%, median change +22%), Alcoholic aetiology, HF duration, baseline LVEF and the absence of LBBB (plus NT-proBNP levels when in the model), were the strongest predictors of LVRR. During a median follow-up of 47 months, 134 patients died (25.4%) and 7 patients (1.3%) received a heart transplant. Patients with LVRR presented better outcomes, regardless of other clinical conditions. CONCLUSIONS: In patients with NIDCM, LVRR was frequent and was associated with improved prognosis. Major clinical predictors of LVRR were alcoholic cardiomyopathy, absence of LBBB, shorter HF duration, and lower baseline LVEF and NT-proBNP levels. Our study advocates for clinical phenotyping of non-ischaemic dilated cardiomyopathy and intense gold-standard treatment optimization of patients according to current guidelines and recommendations in specialized HF units.
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INTRODUCTION AND OBJECTIVES: Optimal medical therapy decreases mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. Women have been underrepresented in clinical trials and not specifically evaluated. This study aimed to compare the safety and effectiveness of drug titration in women vs men. METHODS: This post hoc gender study of the ETIFIC multicenter randomized trial included hospitalized patients with new-onset HF with reduced ejection fraction and New York Heart Association II-III and no contraindications to beta-blockers. A structured 4-month titration process was implemented in HF clinics. The primary endpoint was the mean relative dose (% of target dose) of beta-blockers achieved by women vs men. Secondary endpoints included the mean relative doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists, adverse events, and other clinical outcomes at 6 months. RESULTS: A total of 320 patients were included, 83 (25.93%) women and 237 (74.06%) men (76 vs 213 analyzed). The mean±standard deviation of the relative doses achieved by women vs men were as follows: beta-blockers 62.08%±30.72% vs 64.4%±32.77%, with a difference of-2.32% (95%CI,-10.58-5.94), P = .580; and mineralocorticoid receptor antagonists 79.85%±27.72% vs 67.29%±31.43%, P =.003. No other differences in drug dosage were found. Multivariate analysis showed nonsignificant differences. CV mortality was 1 (1.20%) vs 3 (1.26%), P=1, and HF hospitalizations 0 (0.00%) vs 10 (4.22%), P=.125. CONCLUSIONS: In a post hoc analysis from the HF-titration ETIFIC trial, we found nonsignificant gender differences in drug dosage, cardiovascular mortality, and HF hospitalizations. Trial registry number: NCT02546856.
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Insuficiencia Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Antagonistas Adrenérgicos beta/uso terapéutico , Antagonistas de Receptores de Angiotensina/farmacología , Antagonistas de Receptores de Angiotensina/uso terapéutico , Femenino , Humanos , Masculino , Antagonistas de Receptores de Mineralocorticoides/farmacología , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Factores Sexuales , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
Heart failure (HF) is a clinical syndrome characterized by the presence of dyspnea or limited exertion due to impaired cardiac ventricular filling and/or blood ejection. Because of its high prevalence, it is a major health and economic burden worldwide. Several mechanisms are involved in the pathophysiology of HF. First, the renin-angiotensin-aldosterone system (RAAS) is over-activated, causing vasoconstriction, hypertension, elevated aldosterone levels and sympathetic tone, and eventually cardiac remodeling. Second, an endogenous compensatory mechanism, the natriuretic peptide (NP) system is also activated, albeit insufficiently to counteract the RAAS effects. Since NPs are degraded by the enzyme neprilysin, it was hypothesized that its inhibition could be an important therapeutic target in HF. Sacubitril/valsartan is the first of the class of dual neprilysin and angiotensin receptor inhibitors (ARNI). In patients with HFrEF, treatment with sacubitril/valsartan has demonstrated to significantly reduce mortality and the rates of hospitalization and rehospitalization for HF when compared to enalapril. This communication reviews in detail the demonstrated benefits of sacubitril/valsartan in the treatment of patients with HFrEF, including reduction of mortality and disease progression as well as improvement in cardiac remodeling and quality of life. The hemodynamic and organic effects arising from its dual mechanism of action, including the impact of neprilysin inhibition at the renal level, especially relevant in patients with type 2 diabetes mellitus, are also reviewed. Finally, the evidence on the demonstrated safety and tolerability profile of sacubitril/valsartan in the different subpopulations studied has been compiled. The review of this evidence, together with the recommendations of the latest clinical guidelines, position sacubitril/valsartan as a fundamental pillar in the treatment of patients with HFrEF.
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Objectives: To describe the epidemiology, clinical profile, treatments, and to determine cardiovascular and renal outcomes after two years of follow-up in a contemporary chronic kidneay disease (CKD) population in Spain. This was also analyzed among the DAPA-CKD-like population (patients who met most inclusion criteria of DAPA-CKD trial). Methods: Observational, retrospective, population-based study using BIG-PAC database. The CKD population was defined as patients ≥18 years, with at least one diagnostic code of CKD prior to the index date (January 1st, 2018). CKD was defined as estimated glomerular filtration rate (eGFR) <60mL/min/1.73m2 (CKD-EPI), or albuminuria >30mg/g. Results: We identified 56,435 CKD patients after exclusions (76.4 years, 52.2% men, urine albumin-to-creatinine ratio 390.8mg/g, eGFR 49.7mL/min/1.73m2). CKD prevalence was 4.91% and incidence 2.10 per 1000 patient-years. Regarding treatments, 69.2% were taking renin-angiotensin system inhibitors (only 4.2% at maximal doses) and 3.5% of diabetic patients SGLT-2 inhibitors. During the two years of follow-up, rates of heart failure, all-cause death, myocardial infarction, stroke, and CKD were 17.9, 12.1, 7.2, 6.3, and 5.9 events per 100 patient-years, respectively. During this period, 44% of patients were hospitalized, and 6.8% died during hospitalization. Cardiovascular outcomes were more common in the DAPA-CKD-like population. Conclusions: In Spain, CKD population is older and comorbidities, including diabetes and heart failure, are common. Cardiovascular and renal outcomes are frequent. There is room for improvement in CKD management, particularly through the use of drugs with proven cardiovascular and renal benefit. (AU)
Objetivos: Describir la epidemiología, el perfil clínico, los tratamientos y los eventos cardiovasculares y renales, tras 2 años de seguimiento en una población contemporánea con enfermedad renal crónica (ERC) en España. También se analizó en la población tipo DAPA-CKD (pacientes que cumplían la mayoría de criterios del estudio DAPA-CKD). Métodos: Estudio observacional, retrospectivo, poblacional, empleando la base de datos BIG-PAC. La población con ERC se definió como pacientes ≥18 años, con al menos un código diagnóstico de ERC antes de la fecha índice (01/01/2018). La ERC se definió como filtrado glomerular estimado (FGe)<60ml/min/1,73m2 (CKD-EPI) o albuminuria >30mg/g. Resultados: Se identificaron 56.435 pacientes con ERC, tras exclusiones (76,4 años, 52,2% varones, cociente albúmina-creatinina 390,8mg/g, FGe 49,7ml/min/1,73m2). La prevalencia fue del 4,91% y la incidencia 2,10/1.000 pacientes/año. El 69,2% tomaba inhibidores del sistema renina-angiotensina (solo el 4,2% a dosis máximas) y el 3,5% de los diabéticos inhibidores SGLT-2. Tras 2 años, las tasas de insuficiencia cardiaca, muerte, infarto de miocardio, ictus y ERC fueron 17,9; 12,1; 7,2; 6,3; 5,9 eventos/100 pacientes/año, respectivamente. Además, el 44% hospitalizaron y el 6,8% murieron durante la hospitalización. Los eventos cardiovasculares fueron más frecuentes en la población tipo DAPA-CKD. Conclusiones: En España, la población con ERC es mayor, y las comorbilidades, incluyendo diabetes e insuficiencia cardiaca, comunes. Los eventos cardiovasculares y renales son frecuentes. Hay margen de mejora en el manejo de la ERC, especialmente a través del empleo de fármacos con beneficio cardiovascular y renal. (AU)
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Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Insuficiencia Renal Crónica/tratamiento farmacológico , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/complicaciones , España/epidemiología , Estudios Retrospectivos , Estudios Poblacionales en Salud Pública , Insuficiencia Renal Crónica/mortalidad , Estudios Transversales , Estudios LongitudinalesRESUMEN
OBJECTIVES: To describe the epidemiology, clinical profile, treatments, and to determine cardiovascular and renal outcomes after two years of follow-up in a contemporary chronic kidneay disease (CKD) population in Spain. This was also analyzed among the DAPA-CKD-like population (patients who met most inclusion criteria of DAPA-CKD trial). METHODS: Observational, retrospective, population-based study using BIG-PAC database. The CKD population was defined as patients ≥18 years, with at least one diagnostic code of CKD prior to the index date (January 1st, 2018). CKD was defined as estimated glomerular filtration rate (eGFR) <60mL/min/1.73m2 (CKD-EPI), or albuminuria >30mg/g. RESULTS: We identified 56,435 CKD patients after exclusions (76.4 years, 52.2% men, urine albumin-to-creatinine ratio 390.8mg/g, eGFR 49.7mL/min/1.73m2). CKD prevalence was 4.91% and incidence 2.10 per 1000 patient-years. Regarding treatments, 69.2% were taking renin-angiotensin system inhibitors (only 4.2% at maximal doses) and 3.5% of diabetic patients SGLT-2 inhibitors. During the two years of follow-up, rates of heart failure, all-cause death, myocardial infarction, stroke, and CKD were 17.9, 12.1, 7.2, 6.3, and 5.9 events per 100 patient-years, respectively. During this period, 44% of patients were hospitalized, and 6.8% died during hospitalization. Cardiovascular outcomes were more common in the DAPA-CKD-like population. CONCLUSIONS: In Spain, CKD population is older and comorbidities, including diabetes and heart failure, are common. Cardiovascular and renal outcomes are frequent. There is room for improvement in CKD management, particularly through the use of drugs with proven cardiovascular and renal benefit.
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BACKGROUND: Data about the impact of chronic kidney disease (CKD) on health care costs in Spain are scarce This study was aimed to evaluate cumulative costs and healthcare utilisation in CKD in Spain. METHODS: Observational, retrospective, population-based study, which included adults who received care for CKD between 2015 and 2019. Healthcare and medication costs were summarized on a yearly basis starting from the index date (1st January 2015), and then cumulatively until 2019. RESULTS: We identified 44,214 patients with CKD (year 2015: age 76.4 ± 14.3 years, 49.0% women, albumin-to-creatinine ratio 362.9 ± 176.8 mg/g, estimated glomerular filtration rate 48.7 ± 13.2 mL/min/1.73 m2). During the 2015-2019 period, cumulative CKD associated costs reached 14,728.4 Euros, being cardiovascular disease hospitalizations, particularly due to heart failure and CKD, responsible for 77.1% of costs. Total medication cost accounted for 6.6% of the total cost. There was a progressive decrease in cardiovascular disease hospital costs per year (from 2741.1 Euros in 2015 to 1.971.7 Euros in 2019). This also occurred with cardiovascular and diabetic medication costs, as well as with the proportion of hospitalizations and mortality. Costs and healthcare resources use were higher in the DAPA-CKD like population, but also decreased over time. CONCLUSIONS: Between 2015 and 2019, costs of patients with CKD in Spain were high, with cardiovascular hospitalizations as the key determinant. Medication costs were responsible for only a small proportion of total CKD costs. Improving CKD management, particularly with the use of cardiovascular and renal protective medications may be helpful to reduce CKD burden.
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Insuficiencia Renal Crónica , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Tasa de Filtración Glomerular , Humanos , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/terapia , Estudios Retrospectivos , España/epidemiologíaRESUMEN
Introducción y objetivos: Los bloqueadores beta, inhibidores de la enzima de conversión de la angiotensina (IECA), antagonistas de los receptores de la angiotensina II (ARA-II) y antagonistas de receptores mineralocorticoides, disminuyen mortalidad y hospitalizaciones por insuficiencia cardiaca (IC) en pacientes con IC y fracción de eyección del ventrículo izquierdo reducida. Efecto dosis-dependiente. Se recomienda titulación cuidadosa. Sin embargo, las dosis subóptimas son habituales. Se comparó eficacia y seguridad de la titulación de fármacos enfermeras de IC frente a cardiólogos de IC. Métodos: ETIFIC fue un ensayo de no inferioridad, multicéntrico (20), abierto, controlado y aleatorizado. 320 pacientes hospitalizados con IC de debut, fracción de eyección reducida y New York Heart Association II-III. Sin contraindicación para bloqueadores beta, fueron aleatorizados 1:1, estratificados en bloques de 4 pacientes/hospital, 164 a titulación de enfermeras de IC frente a 156 cardiólogos de IC (analizados 144 frente a 145). El objetivo principal fue la dosis relativa media (% de dosis objetivo) de bloqueadores beta alcanzada a 4 meses. Los objetivos secundarios fueron: la dosis relativa media de IECA, ARA-II y antagonistas de receptores mineralocorticoides, variables asociadas, eventos adversos y resultados clínicos a 6 meses. Resultados: La dosis relativa media ± desviación estándar alcanzada por enfermeras de IC frente a cardiólogos de IC: bloqueadores beta 71,09 ± 31,49% frente a 56,29 ± 31,32%, diferencia 14,8% (IC95%, 7,5-22,1); p <0,001; IECA, 72,61 ± 29,80% frente a 56,13 ± 30,37%; p <0,001; ARA-II, 44,48 ± 33,47% frente a 43,51 ± 33,69%; p=0,93 y antagonistas de receptores mineralocorticoides 71 ± 32,12% frente a 70,47 ± 29,78%; p=0,86; media ± desviación estándar de visitas 6,41 ± 2,82 frente a 2,81 ± 1,58; p <0,001; n (%) efectos adversos 34 (23,6) frente a 30 (20,7), p=0,55; y hospitalizaciones por IC a 6 meses 1 (0,69) frente a 9 (5,51), p=0,01... (AU)
Introduction and objectives: Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists. Methods: ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months. Results: The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01... (AU)
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Humanos , Volumetría , Enfermeras y Enfermeros , Insuficiencia Cardíaca , Antagonistas Adrenérgicos beta , Inhibidores de la Enzima Convertidora de AngiotensinaRESUMEN
OBJECTIVES: To describe the epidemiology, clinical profile, treatments, and to determine cardiovascular and renal outcomes after two years of follow-up in a contemporary chronic kidneay disease (CKD) population in Spain. This was also analyzed among the DAPA-CKD-like population (patients who met most inclusion criteria of DAPA-CKD trial). METHODS: Observational, retrospective, population-based study using BIG-PAC database. The CKD population was defined as patients ≥18 years, with at least one diagnostic code of CKD prior to the index date (January 1st, 2018). CKD was defined as estimated glomerular filtration rate (eGFR) <60mL/min/1.73m2 (CKD-EPI), or albuminuria >30mg/g. RESULTS: We identified 56,435 CKD patients after exclusions (76.4 years, 52.2% men, urine albumin-to-creatinine ratio 390.8mg/g, eGFR 49.7mL/min/1.73m2). CKD prevalence was 4.91% and incidence 2.10 per 1000 patient-years. Regarding treatments, 69.2% were taking renin-angiotensin system inhibitors (only 4.2% at maximal doses) and 3.5% of diabetic patients SGLT-2 inhibitors. During the two years of follow-up, rates of heart failure, all-cause death, myocardial infarction, stroke, and CKD were 17.9, 12.1, 7.2, 6.3, and 5.9 events per 100 patient-years, respectively. During this period, 44% of patients were hospitalized, and 6.8% died during hospitalization. Cardiovascular outcomes were more common in the DAPA-CKD-like population. CONCLUSIONS: In Spain, CKD population is older and comorbidities, including diabetes and heart failure, are common. Cardiovascular and renal outcomes are frequent. There is room for improvement in CKD management, particularly through the use of drugs with proven cardiovascular and renal benefit.
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Diabetes Mellitus , Insuficiencia Cardíaca , Insuficiencia Renal Crónica , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Albúminas , Creatinina , Femenino , Humanos , Masculino , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/terapia , Estudios Retrospectivos , España/epidemiologíaRESUMEN
INTRODUCTION AND OBJECTIVES: Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists. METHODS: ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months. RESULTS: The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01. CONCLUSIONS: ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.
Asunto(s)
Cardiólogos , Insuficiencia Cardíaca , Antagonistas Adrenérgicos beta , Antagonistas de Receptores de Angiotensina , Inhibidores de la Enzima Convertidora de Angiotensina , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
BACKGROUND: Increasing the knowledge about heart failure (HF) costs and their determinants is important to ascertain how HF management can be optimized, leading to a significant decrease of HF costs. This study evaluated the cumulative costs and healthcare utilisation in HF patients in Spain. METHODS: Observational, retrospective, population-based study using BIG-PAC database, which included data from specialized and primary care of people ≥18 years, from seven autonomous communities in Spain, who received care for HF between 2015 and 2019. The healthcare and medication costs were summarized on a yearly basis starting from the index date (1st January 2015), and then cumulatively until 2019. RESULTS: We identified 17,163 patients with HF (year 2015: mean age 77.3 ± 11.8 years, 53.5% men, 51.7% systolic HF, 43.6% on NYHA functional class II). During the 2015-2019 period, total HF associated costs reached 15,373 Euros per person, being cardiovascular disease hospitalizations the most important determinant (75.8%), particularly HF hospitalizations (51.0%). Total medication cost accounted for 7.0% of the total cost. During this period, there was a progressive decrease of cardiovascular disease hospital costs per year (from 2834 Euros in 2015 to 2146 Euros in 2019, P < 0.001), as well as cardiovascular and diabetic medication costs. CONCLUSIONS: During the 2015-2019 period, costs of HF patients in Spain were substantial, being HF hospitalizations the most important determinant. Medication costs represented only a small proportion of total costs. Improving HF management, particularly through the use of drugs that reduce HF hospitalization may be helpful to reduce HF burden.