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1.
Clin Cardiol ; 46(11): 1390-1397, 2023 Nov.
Article En | MEDLINE | ID: mdl-37596723

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.


Atrial Fibrillation , Heart Failure , Stroke , Thromboembolism , Adult , Humans , Male , Middle Aged , Aged , Aged, 80 and over , Female , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Atrial Fibrillation/diagnosis , Rivaroxaban/adverse effects , Anticoagulants/adverse effects , Prospective Studies , Thromboembolism/epidemiology , Thromboembolism/etiology , Thromboembolism/prevention & control , Risk Factors , Heart Failure/complications , Heart Failure/drug therapy , Stroke/etiology
2.
J Comp Eff Res ; 12(3): e220049, 2023 03.
Article En | MEDLINE | ID: mdl-36749006

Aim: It is not well known how comorbidities may change the prognosis of atrial fibrillation (AF) patients. This study was aimed to analyze the impact of cardiovascular disease on this population. Materials & methods: EMIR was a multicenter, prospective study, including 1433 AF patients taking rivaroxaban for ≥6 months. Data were analyzed according to the presence of vascular disease. Results: Coronary artery disease was detected in 16.4%, peripheral artery disease/aortic plaque in 6.7%, vascular disease in 28.3%. Patients with coronary artery disease had higher rates (per 100 patient-years) of major adverse cardiovascular events (2.98 vs 0.71; p < 0.001) and cardiovascular death (1.79 vs 0.41; p = 0.004). Those with vascular disease had higher rates of thromboembolic events (1.47 vs 0.44; p = 0.007), major adverse cardiovascular events (2.03 vs 0.70; p = 0.004), and cardiovascular death (1.24 vs 0.39; p = 0.025). Patients with peripheral artery disease/aortic plaque had similar rates. Conclusion: AF patients with vascular disease have a higher risk of non-embolic outcomes.


Atrial Fibrillation , Cardiovascular Diseases , Coronary Artery Disease , Peripheral Arterial Disease , Stroke , Humans , Rivaroxaban/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Cardiovascular Diseases/chemically induced , Stroke/chemically induced , Prospective Studies , Factor Xa Inhibitors/therapeutic use , Peripheral Arterial Disease/chemically induced , Peripheral Arterial Disease/epidemiology , Anticoagulants/adverse effects
3.
Cardiol J ; 29(6): 936-947, 2022.
Article En | MEDLINE | ID: mdl-36200548

BACKGROUND: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. METHODS: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. RESULTS: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p < 0.01), coronary artery disease (28.2% vs. 12.9%; p < 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p < 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p < 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/systemic embolism/transient ischemic attack, major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, revascularization and cardiovascular death), cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p < 0.01) and cardiovascular death (2.0% vs. 0.2%; p < 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6-7.3; p = 0.002) but not for thromboembolic events or major bleeding. CONCLUSIONS: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding.


Atrial Fibrillation , Heart Failure , Stroke , Thromboembolism , Adult , Humans , Rivaroxaban/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Thromboembolism/complications , Heart Failure/diagnosis , Heart Failure/drug therapy , Heart Failure/epidemiology , Anticoagulants/adverse effects , Risk Factors
4.
J Comp Eff Res ; 11(16): 1173-1184, 2022 11.
Article En | MEDLINE | ID: mdl-36148923

Objective: To analyze the effectiveness and safety of rivaroxaban in patients with atrial fibrillation (AF). Methods: The clinical profile and outcomes of the EMIR study were indirectly compared with those of ROCKET-AF, eight other Spanish observational studies and XANTUS. Results: In EMIR, mean age was 74.2 years and CHA2DS2-VASc was 3.5. In the rivaroxaban arm of the ROCKET-AF trial, mean age was 73 years and CHADS2 was 3.5, whereas in the Spanish studies mean age ranged from 74.9 years to 78.4 years and CHA2DS2-VASc from 3.5 to 4.3. In EMIR, rates of stroke/systemic embolism, major adverse cardiovascular events, cardiovascular death and major bleeding were 0.57, 1.07, 0.63 and 1.04 events/100 patient-years, respectively. In ROCKET-AF, these numbers were 1.7, 3.91, 1.53 and 3.6 events/100 patient-years, respectively. In the Spanish studies, rates of stroke and major bleeding were 0-1.8 and 0.22-4.2 events/100 patient-years, respectively. In XANTUS, rates of stroke, major adverse cardiovascular events and major bleeding were 0.7, 1.8 and 2.1 events/100 patient-years, respectively. Conclusion: Despite the fact that rivaroxaban is prescribed for elderly patients with a high thromboembolic risk, rates of outcomes remain low.


Atrial Fibrillation , Rivaroxaban , Aged , Atrial Fibrillation/drug therapy , Clinical Trials as Topic , Factor Xa Inhibitors/adverse effects , Hemorrhage/epidemiology , Hemorrhage/prevention & control , Humans , Observational Studies as Topic , Registries , Risk Factors , Rivaroxaban/adverse effects , Stroke/epidemiology , Stroke/prevention & control , Treatment Outcome
5.
Cardiol J ; 29(4): 601-609, 2022.
Article En | MEDLINE | ID: mdl-35621092

BACKGROUND: The aim of the study was to evaluate the performance of the 2MACE in patients with atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE. METHODS: This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovascular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE. RESULTS: A total of 1433 patients were included (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for thromboembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs. < 3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% CI 2.216-12.532), major bleeding (OR 4.624; 95% CI 2.163-9.882), MACE (OR 3.202; 95% CI 1.548-6.626) and cardiovascular death (OR 3.395; 95% CI 1.396-8.259). 2MACE was recalculated giving 1 more point to patients with baseline a glomerular filtration rate < 50 mL/min/1.73 m² (2MACER); 2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 (95% CI 0.547-0.755) vs. 0.638 (95% CI 0.534-0.742), respectively; p = 0.361. CONCLUSIONS: In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE.


Atrial Fibrillation , Stroke , Adult , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Follow-Up Studies , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Prospective Studies , Risk Factors , Rivaroxaban/adverse effects , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control
6.
Europace ; 24(1): 4-11, 2022 01 04.
Article En | MEDLINE | ID: mdl-34115857

AIMS: Vitamin K antagonists (VKAs) are effective drugs reducing the risk for stroke in atrial fibrillation (AF), but the benefits derived from such therapy depend on the international normalized ratio (INR) maintenance in a narrow therapeutic range. Here, we aimed to determine independent variables driving poor anticoagulation control [defined as a time in therapeutic range (TTR) <65%] in a 'real world' national cohort of AF patients. METHODS AND RESULTS: The SULTAN registry is a multicentre, prospective study, involving patients with non-valvular AF from 72 cardiology units expert in AF in Spain. At inclusion, all patients naïve for oral anticoagulation were started with VKAs for the first time. For the analysis, the first month of anticoagulation and those patients with <3 INR determinations were disregarded. Patients were followed up during 1 year. A total of 870 patients (53.9% male, the mean age of 73.6 ± 9.2 years, mean CHA2DS2-VASc and HAS-BLED of 3.3 ± 1.5 and 1.4 ± 0.9, respectively) were included in the full analysis set. In overall, 7889 INR determinations were available. At 1-year, the mean TTR was 63.1 ± 22.1% and 49.2% patients had a TTR < 65%. Multivariate Cox regression analysis showed that coronary artery disease [odds ratio (OR) 1.81, 95% confidence interval (CI) 1.14-2.87; P = 0.012] and amiodarone use (OR 1.54, 95% CI 1.01-2.34; P = 0.046) were independently associated with poor quality of anticoagulation (TTR <65%). CONCLUSION: This study demonstrated that the quality of anticoagulation in AF patients newly starting VKAs is sub-optimal. Previous coronary artery disease and concomitant use of amiodarone were identified as independent variables affecting the poor quality of VKA therapy during the first year.


Atrial Fibrillation , Stroke , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Atrial Fibrillation/epidemiology , Female , Humans , International Normalized Ratio/methods , Male , Middle Aged , Prospective Studies , Registries , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiology , Vitamin K
7.
Rev Esp Cardiol (Engl Ed) ; 75(8): 636-648, 2022 Aug.
Article En, Es | MEDLINE | ID: mdl-34903479

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.


Heart Failure , Mineralocorticoid Receptor Antagonists , Adrenergic beta-Antagonists/therapeutic use , Angiotensin Receptor Antagonists/pharmacology , Angiotensin Receptor Antagonists/therapeutic use , Female , Humans , Male , Mineralocorticoid Receptor Antagonists/pharmacology , Mineralocorticoid Receptor Antagonists/therapeutic use , Sex Factors , Stroke Volume , Ventricular Function, Left
9.
Clin Investig Arterioscler ; 33 Suppl 1: 58-64, 2021 May.
Article En, Es | MEDLINE | ID: mdl-33966815

We review all the phase II and III studies carried out with bempedoic acid at the dose of 180mg, alone or in combination with different lipid-lowering drugs and in different subgroups of patients that unequivocally show the efficacy and safety of the drug. We point out some of the potential advantages of its use in clinical practice in patients with statin intolerance and the efficacy in reducing LDL-c when combined with statins, and with statins and ezetimibe, as well as in reducing inflammation markers pending the results of the CV Clear Outcomes trial that will end in 2022.


Dicarboxylic Acids/administration & dosage , Fatty Acids/administration & dosage , Hypercholesterolemia/drug therapy , Hypolipidemic Agents/administration & dosage , Cholesterol, LDL/blood , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Dicarboxylic Acids/adverse effects , Drug Development , Drug Therapy, Combination , Ezetimibe/administration & dosage , Fatty Acids/adverse effects , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Hypolipidemic Agents/adverse effects , Inflammation/drug therapy , Inflammation/pathology
11.
Rev Esp Cardiol (Engl Ed) ; 74(6): 533-543, 2021 Jun.
Article En, Es | MEDLINE | ID: mdl-32591295

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.


Cardiologists , Heart Failure , Adrenergic beta-Antagonists , Angiotensin Receptor Antagonists , Angiotensin-Converting Enzyme Inhibitors , Heart Failure/drug therapy , Humans , Stroke Volume , Ventricular Function, Left
12.
Open Heart ; 7(2)2020 08.
Article En | MEDLINE | ID: mdl-32747454

OBJECTIVE: Primary percutaneous coronary intervention (P-PCI) has demonstrated its efficacy in patients with ST segment elevation myocardial infarction (STEMI). However, patients with STEMI ≥75 years receive less P-PCI than younger patients despite their higher in-hospital morbimortality. The objective of this analysis was to determine the effectiveness of P-PCI in patients with STEMI ≥75 years. METHODS: We included 979 patients with STEMI ≥75 years, from the ATención HOspitalaria del Síndrome coronario study, a registry of 8142 consecutive patients with acute coronary syndrome admitted at 31 Spanish hospitals in 2014-2016. We calculated a propensity score (PS) for the indication of P-PCI. Patients that received or not P-PCI were matched by PS. Using logistic regression, we compared the effectiveness of performing P-PCI versus non-performance for the composite primary event, which included death, reinfarction, acute pulmonary oedema or cardiogenic shock during hospitalisation. RESULTS: Of the included patients, 81.5 % received P-PCI. The matching provided two groups of 169 patients with and without P-PCI. Compared with its non-performance, P-PCI presented a composite event OR adjusted by PS of 0.55 (95% CI 0.34 to 0.89). CONCLUSIONS: Receiving a P-PCI was significantly associated with a reduced risk of major intrahospital complications in patients with STEMI aged 75 years or older.


Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction/therapy , Age Factors , Aged , Aged, 80 and over , Comorbidity , Female , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Pulmonary Edema/mortality , Pulmonary Edema/prevention & control , Recurrence , Registries , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/mortality , Shock, Cardiogenic/mortality , Shock, Cardiogenic/prevention & control , Spain , Time Factors , Treatment Outcome
13.
Rev. esp. cardiol. (Ed. impr.) ; 72(5): 398-406, mayo 2019. tab, graf
Article Es | IBECS | ID: ibc-188387

Introducción y objetivos: Analizar el coste-efectividad del edoxabán frente al acenocumarol en la prevención del ictus y la embolia sistémica en pacientes con fibrilación auricular no valvular (FANV) en España. Métodos: Modelo de Markov, adaptado a España desde la perspectiva del Sistema Nacional de Salud, que simula la evolución de una cohorte hipotética de pacientes con FANV a lo largo de toda su vida a partir de diferentes estados de salud: ictus, hemorragias y otras complicaciones cardiovasculares. Los datos de eficacia y seguridad se obtuvieron a partir de la evidencia clínica disponible (principalmente del estudio en fase III ENGAGE AF-TIMI 48). Los costes del tratamiento de la FANV y sus complicaciones se obtuvieron de fuentes españolas. Resultados: El edoxabán resultó en 0,34 años de vida ajustados por calidad (AVAC) adicionales en comparación con el acenocumarol. El coste incremental con el edoxabán fue de 3.916 euros, derivado principalmente de un mayor coste farmacológico, que se compensa parcialmente por los menores costes de la monitorización del tratamiento y del tratamiento de eventos y complicaciones de la FANV. Se obtuvo un coste por AVAC de 11.518 euros, dentro de los umbrales comúnmente considerados coste-efectivos en España (25.000-30.000 euros/AVAC). Los diferentes análisis de sensibilidad realizados confirmaron la robustez de los resultados. Conclusiones: El edoxabán es una alternativa coste-efectiva frente al acenocumarol en la prevención del ictus y la embolia sistémica en pacientes con FANV en España


Introduction and objectives: To assess the cost-effectiveness of edoxaban versus acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. Methods: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, hemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. Results: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was €3916, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was €11 518, within the thresholds commonly considered cost-effective in Spain (€25 000-€30 000/QALY). The robustness of the results was confirmed by various sensitivity analyses. Conclusions: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain


Humans , Atrial Fibrillation/drug therapy , Embolism/prevention & control , Stroke/prevention & control , Acenocoumarol/therapeutic use , Factor Xa Inhibitors/pharmacokinetics , Cost-Benefit Analysis , Anticoagulants/therapeutic use , Risk Factors
14.
Rev Esp Cardiol (Engl Ed) ; 72(5): 398-406, 2019 May.
Article En, Es | MEDLINE | ID: mdl-31007166

INTRODUCTION AND OBJECTIVES: To assess the cost-effectiveness of edoxaban vs acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. METHODS: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, haemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. RESULTS: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was 3916€, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was 11 518€, within the thresholds commonly considered cost-effective in Spain (25 000-30 000 €/QALY). The robustness of the results was confirmed by various sensitivity analyses. CONCLUSIONS: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain.


Atrial Fibrillation/drug therapy , Embolism/prevention & control , Pyridines/economics , Stroke/prevention & control , Thiazoles/economics , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/economics , Cost-Benefit Analysis , Drug Costs , Facilities and Services Utilization , Factor Xa Inhibitors , Health Resources/statistics & numerical data , Humans , Male , Middle Aged , Pyridines/therapeutic use , Quality of Life , Quality-Adjusted Life Years , Spain , Thiazoles/therapeutic use
16.
Clín. investig. arterioscler. (Ed. impr.) ; 30(5): 240-247, sept.-oct. 2018. tab, graf
Article Es | IBECS | ID: ibc-175442

El control de los factores de riesgo cardiovascular (CV) es esencial en pacientes con enfermedad cardiovascular. La polipíldora CV contiene ácido acetilsalicílico 100 mg, atorvastatina 20 mg o 40 mg y ramipril 2,5 mg, 5 mg o 10 mg en combinación fija. El objetivo fue revisar las evidencias sobre la prevención secundaria de la enfermedad cardiovascular, establecer los posibles perfiles de pacientes donde usar la polipíldora CV con atorvastatina 40mg en prevención CV secundaria (P40PS) y definir las situaciones prioritarias de empleo de la P40PS. Se realizó una revisión bibliográfica, que se complementó con la opinión clínica de 19 especialistas. Durante la hospitalización y al alta, la P40PS es una opción en pacientes ingresados por un evento aterotrombótico de cualquier territorio, enfermedad arterial periférica u otras causas y con indicación de los monocomponentes. Se plantea su uso prioritario en: intolerancia previa a la dosis de atorvastatina 80 mg, edad > 75 años, bajo peso, insuficiencia renal crónica estadio 3, hipotiroidismo, interacciones farmacológicas y origen asiático. En el ámbito extrahospitalario, la P40PS es una alternativa terapéutica en los pacientes con necesidad de prevención CV secundaria con indicación para recibir los monocomponentes y las situaciones prioritarias son recibir los tres componentes por separado, requerir polimedicación, falta de adherencia o de comprensión del tratamiento, y falta de control de los factores de riesgo CV. Este trabajo es el primero con propuestas de uso de la P40PS y puede facilitar el tratamiento de los pacientes con enfermedad cardiovascular en prevención secundaria


Controlling cardiovascular risk factors (CV) is essential for patients with cardiovascular disease. The CV polypill contains aspirin 100 mg, atorvastatin 20 mg or 40 mg, and ramipril 2.5 mg, 5 mg or 10 mg in a fixed combination pill. The objective was to review the evidence on the secondary prevention of cardiovascular disease, to establish the eventual patient profiles suitables to consider the use of CV polypill with atorvastatin 40 mg in secondary CV prevention (P40PS), and to define the priority situations most adequate for the use of P40PS. A bibliographic review was carried out, which was complemented with the clinical opinion of 19 specialists. During hospitalization and discharge, P40PS is an option for patients admitted because of an atherothrombotic event, peripheral arterial disease, or other causes, and with the indication of the monocomponents. Its priority use is proposed in: prior intolerance to the highest dose of atorvastatin (80 mg), age > 75 years, low weight, stage 3 of chronic renal failure, hypothyroidism, drug interactions and Asian origin. Outside the hospital setting, the P40PS is a therapeutic alternative in patients with a need for secondary CV prevention and with indication to receive the monocomponents. The priority situations to receive the P40PS are: to be taking the three components separately, to require polypharmacy, lack of adherence or understanding of the treatment, and lack of control of CV risk factors. This work is the first with proposals for the use of P40PS and can facilitate the treatment of patients with cardiovascular disease in secondary prevention


Humans , Male , Female , Aged , Aged, 80 and over , Cardiovascular Diseases/drug therapy , Secondary Prevention/methods , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/physiopathology , Atorvastatin/administration & dosage , Drug Therapy, Combination/methods , Atherosclerosis , Aspirin/administration & dosage , /therapeutic use , Prescriptions/standards
18.
Clin Investig Arterioscler ; 30(5): 240-247, 2018.
Article En, Es | MEDLINE | ID: mdl-30017176

Controlling cardiovascular risk factors (CV) is essential for patients with cardiovascular disease. The CV polypill contains aspirin 100mg, atorvastatin 20mg or 40mg, and ramipril 2.5mg, 5mg or 10mg in a fixed combination pill. The objective was to review the evidence on the secondary prevention of cardiovascular disease, to establish the eventual patient profiles suitables to consider the use of CV polypill with atorvastatin 40mg in secondary CV prevention (P40PS), and to define the priority situations most adequate for the use of P40PS. A bibliographic review was carried out, which was complemented with the clinical opinion of 19 specialists. During hospitalization and discharge, P40PS is an option for patients admitted because of an atherothrombotic event, peripheral arterial disease, or other causes, and with the indication of the monocomponents. Its priority use is proposed in: prior intolerance to the highest dose of atorvastatin (80mg), age>75 years, low weight, stage 3 of chronic renal failure, hypothyroidism, drug interactions and Asian origin. Outside the hospital setting, the P40PS is a therapeutic alternative in patients with a need for secondary CV prevention and with indication to receive the monocomponents. The priority situations to receive the P40PS are: to be taking the three components separately, to require polypharmacy, lack of adherence or understanding of the treatment, and lack of control of CV risk factors. This work is the first with proposals for the use of P40PS and can facilitate the treatment of patients with cardiovascular disease in secondary prevention.


Aspirin/administration & dosage , Atorvastatin/administration & dosage , Cardiovascular Diseases/prevention & control , Ramipril/administration & dosage , Antihypertensive Agents/administration & dosage , Cardiovascular Diseases/etiology , Drug Combinations , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Medication Adherence , Platelet Aggregation Inhibitors/administration & dosage , Risk Factors , Secondary Prevention/methods
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