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BACKGROUND: Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown. METHODS: In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis. RESULTS: A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups. CONCLUSIONS: Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.).
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Insuficiência Cardíaca , Infarto do Miocárdio , Inibidores do Transportador 2 de Sódio-Glicose , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Compostos Benzidrílicos/uso terapêutico , Compostos Benzidrílicos/efeitos adversos , Método Duplo-Cego , Seguimentos , Glucosídeos/uso terapêutico , Glucosídeos/efeitos adversos , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/prevenção & controle , Hospitalização , Estimativa de Kaplan-Meier , Infarto do Miocárdio/complicações , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/mortalidade , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Resultado do Tratamento , Fatores de Risco de Doenças CardíacasRESUMO
BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) events in patients with type 2 diabetes at high cardiovascular risk, chronic kidney disease, or prevalent HF irrespective of ejection fraction. Whereas the EMPACT-MI trial (Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients With Acute Myocardial Infarction) showed that empagliflozin does not reduce the risk of the composite of hospitalization for HF and all-cause death, the effect of empagliflozin on first and recurrent HF events after myocardial infarction is unknown. METHODS: EMPACT-MI was a double-blind, randomized, placebo-controlled, event-driven trial that randomized 6522 patients hospitalized for acute myocardial infarction at risk for HF on the basis of newly developed left ventricular ejection fraction of <45% or signs or symptoms of congestion to receive empagliflozin 10 mg daily or placebo within 14 days of admission. In prespecified secondary analyses, treatment groups were analyzed for HF outcomes. RESULTS: Over a median follow-up of 17.9 months, the risk for first HF hospitalization and total HF hospitalizations was significantly lower in the empagliflozin compared with the placebo group (118 [3.6%] versus 153 [4.7%] patients with events; hazard ratio, 0.77 [95% CI, 0.60, 0.98]; P=0.031, for first HF hospitalization; 148 versus 207 events; rate ratio, 0.67 [95% CI, 0.51, 0.89]; P=0.006, for total HF hospitalizations). Subgroup analysis showed consistency of empagliflozin benefit across clinically relevant patient subgroups for first and total HF hospitalizations. The need for new use of diuretics, renin-angiotensin modulators, or mineralocorticoid receptor antagonists after discharge was less in patients randomized to empagliflozin versus placebo (all P<0.05). CONCLUSIONS: Empagliflozin reduced the risk of HF in patients with left ventricular dysfunction or congestion after acute myocardial infarction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04509674.
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Compostos Benzidrílicos , Glucosídeos , Insuficiência Cardíaca , Hospitalização , Infarto do Miocárdio , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Glucosídeos/uso terapêutico , Compostos Benzidrílicos/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/mortalidade , Masculino , Feminino , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/complicações , Idoso , Pessoa de Meia-Idade , Método Duplo-Cego , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Resultado do Tratamento , Volume Sistólico/efeitos dos fármacosRESUMO
James et al1 report the results of the DAPA-MI (DAPAagliflozin in patients without diabetes mellitus with acute Myocardial Infarction) trial, which studied the efficacy and safety of early initiation of dapagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, in patients with acute myocardial infarction (MI) without type 2 diabetes (T2D) or heart failure (HF). The trial was conducted within the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) and NICOR (National Institute for Cardiovascular Outcomes Research) registries, leveraging where possible routinely collected health data to augment screening, baseline characteristic ascertainment, and clinical follow-up.
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Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Infarto do Miocárdio , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Diabetes Mellitus Tipo 2/diagnóstico , Infarto do Miocárdio/diagnóstico , Insuficiência Cardíaca/diagnóstico , SuéciaRESUMO
Background: In patients with type 2 diabetes mellitus (T2DM), a history of an ischemic event is associated with increased risk for cardiovascular (CV) disease. Whether patients with T2DM and a recent atherothrombotic diagnosis benefit from early intervention with a sodium-glucose co-transporter 2 inhibitor is unknown. Methods: This study is a secondary analysis of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients-Removing Excess Glucose (EMPA-REG OUTCOME), which compared empagliflozin to placebo in adults with T2DM and atherosclerotic CV disease (ASCVD). Participants were categorized based on the time since their last qualifying ASCVD diagnosis (≤ 1 year vs > 1 year). Qualifying ASCVD diagnoses included ischemic or hemorrhagic stroke, myocardial infarction, coronary artery disease, and peripheral artery disease. The primary outcome was a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke. Results: A total of 6796 participants (n = 4547 empagliflozin, n = 2249 placebo) were included. Median time since the last qualifying ASCVD diagnosis was 3.8 years (quartile 1-quartile 3: 1.5-7.6), and most qualifying diagnoses occurred > 1 year before randomization (≤ 1 year, n = 1214; > 1 year, n = 5582). Empagliflozin reduced the incidence of the primary outcome irrespective of the time since the last qualifying ASCVD diagnosis (≤ 1 year: hazard ratio 0.82, 95% confidence interval: 0.57-1.16; vs > 1 year: hazard ratio 0.85, 95% confidence interval: 0.72-1.00; P for interaction = 0.84). Results were similar for the composite of CV death or hospitalization for heart failure. Conclusions: Empagliflozin improved CV outcomes in participants with T2DM, irrespective of the time since the last qualifying ASCVD diagnosis at randomization. Prospective trials are necessary to investigate the use of sodium-glucose co-transporter 2 inhibitors at the time of an acute ASCVD event. Trial Registration: EMPA-REG OUTCOME (Clinicaltrials.gov identifier: NCT01131676).
Contexte: Chez les patients atteints de diabète de type 2 (DT2), des antécédents d'accidents ischémiques sont associés à un risque accru de maladie cardiovasculaire (CV). On ignore si une intervention précoce par un inhibiteur du cotransporteur sodium-glucose de type 2 pourrait être bénéfique pour les patients atteints de DT2 ayant récemment reçu un diagnostic d'athérothrombose. Méthodologie: Cette étude est une analyse secondaire de l'essai EMPA-REG OUTCOME ( Empa gliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients R emoving E xcess G lucose), qui visait à comparer l'empagliflozine à un placebo chez des adultes atteints de DT2 et d'une maladie CV athéroscléreuse. Les participants ont été répartis selon le temps écoulé depuis leur plus récent diagnostic de maladie CV athéroscléreuse admissible (≤ 1 an vs > 1 an). Les diagnostics de maladies CV athéroscléreuses admissibles comprenaient un accident vasculaire cérébral ischémique ou hémorragique, un infarctus du myocarde, une coronaropathie et une artériopathie périphérique. Le critère d'évaluation principal était composé des décès d'origine CV, des infarctus du myocarde non mortels et des accident vasculaire cérébral non mortels. Résultats: Au total, 6796 participants (n = 4547 pour l'empagliflozine, n = 2249 pour le placebo) ont été inclus. Le temps écoulé médian depuis le diagnostic le plus récent de maladie CV athéroscléreuse admissible était de 3,8 ans (quartile 1-quartile 3 : 1,5-7,6). La plupart des diagnostics admissibles avaient été posés plus de 1 an avant la répartition aléatoire (≤ 1 an, n = 1214; > 1 an, n = 5582). L'empagliflozine a réduit la fréquence des événements constituant le critère d'évaluation principal, sans égard au temps écoulé depuis le plus récent diagnostic de maladie CV athéroscléreuse admissible (≤ 1 an : rapport des risques instantanés 0,82, intervalle de confiance à 95 % : 0,57-1,16; vs > 1 an : rapport des risques instantanés 0,85, intervalle de confiance à 95 % : 0,72-1,00; p pour l'interaction = 0,84). Les résultats étaient comparables à ceux observés pour le critère composé des décès d'origine CV et des hospitalisations pour insuffisance cardiaque. Conclusions: L'empagliflozine a amélioré les issues CV chez les patients atteints de DT2 sans égard au temps écoulé depuis le plus récent diagnostic de maladie CV admissible au moment de la répartition aléatoire. Des essais prospectifs sont nécessaires pour étudier l'utilisation des inhibiteurs du cotransporteur sodium-glucose de type 2 lorsqu'une manifestation de maladie CV athéroscléreuse aiguë survient. Inscription de l'essai: EMPA-REG OUTCOME (numéro d'identification dans clinicaltrials.gov : NCT01131676).
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BACKGROUND: Sodium-glucose co-transporter-2 (SGLT2) inhibitors have been studied in patients with heart failure, type 2 diabetes, chronic kidney disease, atherosclerotic cardiovascular disease, and acute myocardial infarction. Individual trials were powered to study composite outcomes in one disease state. We aimed to evaluate the treatment effect of SGLT2 inhibitors on specific clinical endpoints across multiple demographic and disease subgroups. METHODS: In this systematic review and meta-analysis, we queried online databases (PubMed, Cochrane CENTRAL, and SCOPUS) up to Feb 10, 2024, for primary and secondary analyses of large trials (n>1000) of SGLT2 inhibitors in patients with heart failure, type 2 diabetes, chronic kidney disease, and atherosclerotic cardiovascular disease (including acute myocardial infarction). Outcomes studied included composite of first hospitalisation for heart failure or cardiovascular death, first hospitalisation for heart failure, cardiovascular death, total (first and recurrent) hospitalisation for heart failure, and all-cause mortality. Effect sizes were pooled using random-effects models. This study is registered with PROSPERO, CRD42024513836. FINDINGS: We included 15 trials (N=100 952). Compared with placebo, SGLT2 inhibitors reduced the risk of first hospitalisation for heart failure by 29% in patients with heart failure (hazard ratio [HR] 0·71 [95% CI 0·67-0·77]), 28% in patients with type 2 diabetes (0·72 [0·67-0·77]), 32% in patients with chronic kidney disease (0·68 [0·61-0·77]), and 28% in patients with atherosclerotic cardiovascular disease (0·72 [0·66-0·79]). SGLT2 inhibitors reduced cardiovascular death by 14% in patients with heart failure (HR 0·86 [95% CI 0·79-0·93]), 15% in patients with type 2 diabetes (0·85 [0·79-0·91]), 11% in patients with chronic kidney disease (0·89 [0·82-0·96]), and 13% in patients with atherosclerotic cardiovascular disease (0·87 [0·78-0·97]). The benefit of SGLT2 inhibitors on both first hospitalisation for heart failure and cardiovascular death was consistent across the majority of the 51 subgroups studied. Notable exceptions included acute myocardial infarction (22% reduction in first hospitalisation for heart failure; no effect on cardiovascular death) and heart failure with preserved ejection fraction (26% reduction in first hospitalisation for heart failure; no effect on cardiovascular death). INTERPRETATION: SGLT2 inhibitors reduced heart failure events and cardiovascular death in patients with heart failure, type 2 diabetes, chronic kidney disease, and atherosclerotic cardiovascular disease. These effects were consistent across a wide range of subgroups within these populations. This supports the eligibility of a large population with cardiorenal-metabolic diseases for treatment with SGLT2 inhibitors. FUNDING: None.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Inibidores do Transportador 2 de Sódio-Glicose , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/mortalidade , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Doenças Cardiovasculares/mortalidade , Insuficiência Renal Crônica/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/mortalidade , Hospitalização/estatística & dados numéricosRESUMO
Importance: High-dose trivalent compared with standard-dose quadrivalent influenza vaccine did not significantly reduce all-cause mortality or cardiopulmonary hospitalizations in patients with high-risk cardiovascular disease in the INVESTED trial. Whether humoral immune response to influenza vaccine is associated with clinical outcomes is unknown. Objective: To examine the antibody response to high-dose trivalent compared with standard-dose quadrivalent inactivated influenza vaccine and its associations with clinical outcomes. Design, Setting, and Participants: This secondary analysis is a prespecified analysis of the immune response substudy of the randomized, double-blind, active-controlled INVESTED trial, which was conducted at 157 sites in the United States and Canada over 3 influenza seasons between September 2016 and January 2019. Antibody titers were determined by hemagglutination inhibition assays at randomization and 4 weeks during the 2017-2018 and 2018-2019 seasons. Eligibility criteria included recent acute myocardial infarction or heart failure hospitalization and at least 1 additional risk factor. Data were analyzed from February 2023 to June 2023. Main Outcomes and Measures: Mean antibody titer change, seroprotection (antibody titer level ≥1:40) and seroconversion (≥4-fold increase in titer) at 4 weeks, and the association between seroconversion status and the risk for adverse clinical outcomes. Interventions: High-dose trivalent or standard-dose quadrivalent inactivated influenza vaccine, with revaccination up to 3 seasons. Results: Antibody data were available for 658 of 5260 randomized participants (12.5%; mean [SD] age, 66.2 [11.4] years; 507 male [77.1%], 151 female [22.9%]; 348 with heart failure [52.9%]). High-dose vaccine was associated with an increased magnitude in antibody titers for A/H1N1, A/H3N2, and B-type antigens compared with standard dose. More than 92% of all participants achieved seroprotection for each of the contained antigens, while seroconversion rates were higher in participants who received high-dose vaccine. Seroconversion for any antigen was not associated with the risk for cardiopulmonary hospitalizations or all-cause mortality (hazard ratio, 1.09; 95% CI, 0.79-1.53; P = .59), irrespective of randomized treatment (P = .38 for interaction). Conclusions and Relevance: High-dose vaccine elicited a more robust humoral response in patients with heart failure or prior myocardial infarction enrolled in the INVESTED trial, with no association between seroconversion status and the risk for cardiopulmonary hospitalizations or all-cause mortality. Vaccination to prevent influenza remains critical in high-risk populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02787044.
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Vacinas contra Influenza , Influenza Humana , Humanos , Vacinas contra Influenza/imunologia , Vacinas contra Influenza/administração & dosagem , Masculino , Feminino , Idoso , Influenza Humana/prevenção & controle , Influenza Humana/imunologia , Método Duplo-Cego , Pessoa de Meia-Idade , Doenças Cardiovasculares/imunologia , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/mortalidade , Anticorpos Antivirais/sangue , Hospitalização/estatística & dados numéricos , Testes de Inibição da Hemaglutinação/métodos , Infarto do Miocárdio/imunologia , Insuficiência Cardíaca/imunologiaRESUMO
BACKGROUND: Dyslipidemia management is a cornerstone in cardiovascular disease prevention and relies heavily on patient adherence to lifestyle modifications and medications. Numerous cholesterol patient education materials are available online, but it remains unclear whether these resources are suitable for the majority of North American adults given the prevalence of low health literacy. This review aimed to (1) identify printable cholesterol patient education materials through an online search, and (2) evaluate the readability, understandability, and actionability of each resource to determine its utility in practice. METHODS AND RESULTS: We searched the MEDLINE database for peer-reviewed educational materials and the websites of Canadian and American national health organizations for gray literature. Readability was measured using the Flesch-Kincaid Grade Level, and scores between fifth- and sixth-grade reading levels were considered adequate. Understandability and actionability were scored using the Patient Education Materials Assessment Tool and categorized as superior (>80%), adequate (50%-70%), or inadequate (<50%). Our search yielded 91 results that were screened for eligibility. Among the 22 educational materials included in the study, 15 were identified through MEDLINE, and 7 were from websites. The readability across all materials averaged an 11th-grade reading level (Flesch-Kincaid Grade Level=11.9±2.59). The mean±SD understandability and actionability scores were 82.8±6.58% and 40.9±28.60%, respectively. CONCLUSIONS: The readability of online cholesterol patient education materials consistently exceeds the health literacy level of the average North American adult. Many resources also inadequately describe action items for individuals to self-manage their cholesterol, representing an implementation gap in cardiovascular disease prevention.
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Compreensão , Letramento em Saúde , Educação de Pacientes como Assunto , Humanos , Dislipidemias/tratamento farmacológico , Dislipidemias/sangue , Dislipidemias/diagnóstico , Dislipidemias/epidemiologia , Dislipidemias/terapia , Internet , Colesterol/sangue , Doenças Cardiovasculares/prevenção & controle , Conhecimentos, Atitudes e Prática em SaúdeRESUMO
Background: Adult congenital heart disease (ACHD) patients have significant morbidity and rise in cardiac admissions. Their outcome with high-dose influenza vaccination is unknown in comparison to those without ACHD. Objectives: The purpose of this study was to compare all-cause mortality or cardiopulmonary hospitalizations in self-identified ACHD versus non-ACHD patients receiving high- or low-dose influenza vaccination within the INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure trial. Methods: We prospectively included ACHD patients in the INVESTED (INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure) trial. The primary endpoint was all-cause death or hospitalization for cardiovascular or pulmonary causes. Results: Of the 272 ACHD patients, 132 were randomly assigned to receive high-dose trivalent and 140 to standard-dose quadrivalent influenza vaccine. Compared to the non-ACHD cohort (n = 4,988), ACHD patients were more likely to be younger, women, smokers, have atrial fibrillation, and have a qualifying event of heart failure. The primary outcome was 49.8 events versus 42.8 events per 100 person-years (adjusted HR: 1.17; 95% CI: 0.95-1.45; P = 0.144) in the ACHD group and non-ACHD group, respectively. The interaction between ACHD status and randomized treatment effect was not significant for the primary outcome (P = 0.858). Vaccine-related adverse events were similar in both groups. Conclusions: Patients who self-identify as being ACHD had similar primary outcome of all-cause death or hospitalization for cardiovascular or pulmonary causes compared to non-ACHD cohort. High-dose influenza vaccination was similar to standard-dose influenza vaccination on the primary outcome in patients who self-identify as ACHD.
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AIMS: To describe the baseline characteristics of participants in the FINEARTS-HF trial, contextualized with prior trials including patients with heart failure (HF) with mildly reduced and preserved ejection fraction (HFmrEF/HFpEF). The FINEARTS-HF trial is comparing the effects of the non-steroidal mineralocorticoid receptor antagonist finerenone with placebo in reducing cardiovascular death and total worsening HF events in patients with HFmrEF/HFpEF. METHODS AND RESULTS: Patients with symptomatic HF, left ventricular ejection fraction (LVEF) ≥40%, estimated glomerular filtration rate ≥ 25 ml/min/1.73 m2, elevated natriuretic peptide levels and evidence of structural heart disease were enrolled and randomized to finerenone titrated to a maximum of 40 mg once daily or matching placebo. We validly randomized 6001 patients to finerenone or placebo (mean age 72 ± 10 years, 46% women). The majority were New York Heart Association functional class II (69%). The baseline mean LVEF was 53 ± 8% (range 34-84%); 36% of participants had a LVEF <50% and 64% had a LVEF ≥50%. The median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1041 (interquartile range 449-1946) pg/ml. A total of 1219 (20%) patients were enrolled during or within 7 days of a worsening HF event, and 3247 (54%) patients were enrolled within 3 months of a worsening HF event. Compared with prior large-scale HFmrEF/HFpEF trials, FINEARTS-HF participants were more likely to have recent (within 6 months) HF hospitalization and greater symptoms and functional limitations. Further, concomitant medications included a larger percentage of sodium-glucose cotransporter 2 inhibitors and angiotensin receptor-neprilysin inhibitors than previous trials. CONCLUSIONS: FINEARTS-HF has enrolled a broad range of high-risk patients with HFmrEF and HFpEF. The trial will determine the safety and efficacy of finerenone in this population.
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Insuficiência Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Naftiridinas , Volume Sistólico , Humanos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/tratamento farmacológico , Volume Sistólico/fisiologia , Feminino , Masculino , Idoso , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Naftiridinas/uso terapêutico , Método Duplo-Cego , Função Ventricular Esquerda/fisiologia , Função Ventricular Esquerda/efeitos dos fármacos , Pessoa de Meia-Idade , Resultado do Tratamento , Taxa de Filtração Glomerular/fisiologia , Peptídeo Natriurético Encefálico/sangueRESUMO
BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) hospitalizations but not all-cause mortality when started within 14 days of acute myocardial infarction (AMI). OBJECTIVES: This study sought to evaluate the association of left ventricular ejection fraction (LVEF), congestion, or both, with outcomes and the impact of empagliflozin in reducing HF risk post-AMI. METHODS: In the EMPACT-MI (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction) trial, patients were randomized within 14 days of an AMI complicated by either newly reduced LVEF<45%, congestion, or both, to empagliflozin (10 mg daily) or placebo and were followed up for a median of 17.9 months. RESULTS: Among 6,522 patients, the mean baseline LVEF was 41 ± 9%; 2,648 patients (40.6%) presented with LVEF <45% alone, 1,483 (22.7%) presented with congestion alone, and 2,181 (33.4%) presented with both. Among patients in the placebo arm of the trial, multivariable adjusted risk for each 10-point reduction in LVEF included all-cause death or HF hospitalization (HR: 1.49; 95% CI: 1.31-1.69; P < 0.0001), first HF hospitalization (HR: 1.64; 95% CI: 1.37-1.96; P < 0.0001), and total HF hospitalizations (rate ratio [RR]: 1.89; 95% CI: 1.51-2.36; P < 0.0001). The presence of congestion was also associated with a significantly higher risk for each of these outcomes (HR: 1.52, 1.94, and RR: 2.03, respectively). Empagliflozin reduced the risk for first (HR: 0.77; 95% CI: 0.60-0.98) and total (RR: 0.67; 95% CI: 0.50-0.89) HF hospitalizations, irrespective of LVEF or congestion, or both. The safety profile of empagliflozin was consistent across baseline LVEF and irrespective of congestion status. CONCLUSIONS: In patients with AMI, the severity of left ventricular dysfunction and the presence of congestion was associated with worse outcomes. Empagliflozin reduced first and total HF hospitalizations across the range of LVEF with and without congestion. (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction [EMPACT-MI]; NCT04509674).
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Compostos Benzidrílicos , Glucosídeos , Insuficiência Cardíaca , Infarto do Miocárdio , Inibidores do Transportador 2 de Sódio-Glicose , Função Ventricular Esquerda , Humanos , Compostos Benzidrílicos/uso terapêutico , Glucosídeos/uso terapêutico , Masculino , Feminino , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/mortalidade , Pessoa de Meia-Idade , Idoso , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Função Ventricular Esquerda/efeitos dos fármacos , Volume Sistólico/efeitos dos fármacos , Hospitalização/estatística & dados numéricos , Método Duplo-Cego , SeguimentosRESUMO
Background: Primary care electronic medical record (EMR) data can be used to identify, manage, and screen hypertension cases. However, this approach relies on completeness and accessibility of documented blood pressure (BP) values. With the large switch to virtual care due to the COVID-19 pandemic, we assessed BP documentation in primary care EMRs during the pandemic, across patient and physician groups. Methods: Hypertension-related visits were identified during the pre-pandemic (January 2017 to February 2020) and pandemic (March 2020 to December 2021) periods from a primary care EMR database in Ontario, Canada. Clustered logistic regression models were used to analyze the relationship of physician and patient characteristics with an outcome variable of documented BP. A chart review of 3200 hypertension visits without a BP recorded in structured data fields was conducted to determine if BP was recorded in progress notes. Results: Pre-pandemic, 75.7% of hypertension-related visits (113,966 of 150,511) had a BP recorded in structured documentation, but this significantly decreased to 36.4% (26,660 of 73,239) during the pandemic (odds ratio [OR] = 0.18, 95% confidence interval [CI]: 0.18-0.19). For virtual visits, 14.3% (6357 of 44,572) had a documented BP, vs 74.0% (20,056 of 27,089) for in-person visits. Chart review found that 55.9% of hypertension visits had no associated BP in structured documentation, but did have a BP recorded in the progress note. Male providers, compared to female providers, were less likely to record BPs pre-pandemic (OR = 0.45, 95% CI: 0.32-0.63) and during the pandemic, for both virtual visits (OR = 0.48, 95% CI: 0.32-0.71) and in-person visits (OR = 0.46, 95% CI: 0.33-0.64). Conclusions: BP documented in primary care EMRs declined during the pandemic, most likely due to high rates of virtual visits impacting hypertension detection and management.
Contexte: Les données des dossiers médicaux électroniques (DME) provenant des soins primaires peuvent être utilisées pour détecter, prendre en charge et dépister les cas d'hypertension. Cependant, cette approche dépend de l'accessibilité et de l'exhaustivité des valeurs de pression artérielle (PA) consignées aux dossiers. Étant donné l'important passage aux soins virtuels attribuable à la pandémie de COVID-19, nous avons évalué la façon dont la PA avait été consignée dans les DME de soins primaires pendant la pandémie, parmi des groupes de patients et de médecins. Méthodologie: Les consultations liées à l'hypertension pendant les périodes pré-pandémique (de janvier 2017 à février 2020) et pandémique (de mars 2020 à décembre 2021) ont été recueillies d'une banque de données de DME de soins primaires en Ontario (Canada). Des modèles de régression logistique regroupée ont été utilisés pour analyser le lien entre les caractéristiques des médecins et de patients et une variable de résultats des PA consignées. Une revue des dossiers portant sur 3200 consultations pour hypertension sans consignation de la PA dans les champs de données structurés a été effectuée afin de déterminer si la PA avait été notée dans les notes d'évolution. Résultats: Avant la pandémie, la PA avait été consignée dans une documentation structurée pour 75,7 % (113 966 sur 150 511) des consultations pour hypertension, mais cette proportion a chuté considérablement à 36,4 % (26 660 sur 73 239) pendant la pandémie (rapport des cotes [RC] = 0,18; intervalle de confiance [IC] à 95 % : 0,18-0,19). Pour ce qui est des consultations virtuelles, la PA a été consignée dans 14,3 % (6357 sur 44 572) des cas, comparativement à 74,0 % (20 056 sur 27 089) pour les consultations en personne. Une analyse des dossiers a révélé que pour 55,9 % des consultations pour hypertension, aucune mesure de PA ne figurait dans la documentation structurée, mais qu'une valeur de PA avait toutefois été consignée dans les notes d'évolution. Les professionnels de la santé masculins, comparativement aux femmes, ont été moins susceptibles de consigner les valeurs de PA avant la pandémie (RC = 0,45; IC à 95 % : 0,32-0,63) et pendant la pandémie, tant lors des consultations virtuelles (RC = 0,48; IC à 95 % : 0,32-0,71) que des consultations en personne (RC = 0,46; IC à 95 % : 0,33-0,64). Conclusions: L'inscription des valeurs de PA dans les DME de soins primaires a décliné pendant la pandémie, fort probablement en raison de la proportion élevée de consultations virtuelles, ce qui a eu une incidence sur la détection et la prise en charge de l'hypertension.
RESUMO
Study objective: Develop and evaluate a model that uses health administrative data to categorize cardiovascular (CV) cause of death (COD). Design: Population-based cohort. Setting: Ontario, Canada. Participants: Decedents ≥ 40 years with known COD between 2008 and 2015 in the CANHEART cohort, split into derivation (2008 to 2012; n = 363,778) and validation (2013 to 2015; n = 239,672) cohorts. Main outcome measures: Model performance. COD was categorized as CV or non-CV with ICD-10 codes as the gold standard. We developed a logistic regression model that uses routinely collected healthcare administrative to categorize CV versus non-CV COD. We assessed model discrimination and calibration in the validation cohort. Results: The strongest predictors for CV COD were history of stroke, history of myocardial infarction, history of heart failure, and CV hospitalization one month before death. In the validation cohort, the c-statistic was 0.80, the sensitivity 0.75 (95 % CI 0.74 to 0.75) and the specificity 0.71 (95 % CI 0.70 to 0.71). In the primary prevention validation sub-cohort, the c-statistic was 0.81, the sensitivity 0.71 (95 % CI 0.70 to 0.71) and the specificity 0.75 (95 % CI 0.75 to 0.75) while in the secondary prevention sub-cohort the c-statistic was 0.74, the sensitivity 0.81 (95 % CI 0.81 to 0.82) and the specificity 0.54 (95 % CI 0.53 to 0.54). Conclusion: Modelling approaches using health administrative data show potential in categorizing CV COD, though further work is necessary before this approach is employed in clinical studies.