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1.
N Engl J Med ; 381(21): 1995-2008, 2019 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-31535829

RESUMO

BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).


Assuntos
Compostos Benzidrílicos/uso terapêutico , Glucosídeos/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Idoso , Compostos Benzidrílicos/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Doenças Cardiovasculares/mortalidade , Terapia Combinada , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Quimioterapia Combinada , Feminino , Glucosídeos/efeitos adversos , Hemoglobina A Glicada/análise , Insuficiência Cardíaca/complicações , Hospitalização , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Volume Sistólico/efeitos dos fármacos , Disfunção Ventricular Esquerda/complicações , Disfunção Ventricular Esquerda/tratamento farmacológico
2.
J Heart Valve Dis ; 26(3): 290-294, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-29092113

RESUMO

BACKGROUND AND AIM OF THE STUDY: Progression of tricuspid regurgitation (TR) may occur after mitral valve replacement (MVR). The study aim was to define the independent predictors for new severe TR after MVR to treat rheumatic heart disease. METHODS: A total of 413 patients (177 men, 236 women; mean age 40.9 ± 9.2 years) with rheumatic heart disease undergoing MVR without concomitant tricuspid valve repair at the authors' institute between 1995 and 2005, who did not have preoperative severe TR, were followed for at least one year postoperatively. Survival without severe TR was estimated using the Kaplan-Meier method. Independent predictors for new severe TR were identified using multiple Cox regression analysis. RESULTS: During a median follow up of 13 years there were two late deaths, and 46 patients (11.1%) had new severe TR. Survival without severe TR was 88.0 ± 1.7% at 10 years. Independent predictors for new severe TR were preoperative moderate TR (HR 2.401; p = 0.008) and atrial fibrillation (AF) (HR 2.119; p = 0.018). At the most recent follow up, furosemide was used in 23.9% patients with and 7.3% patients without new severe TR (p = 0.001). Patients with new severe TR had larger right ventricles and higher pulmonary artery pressures on echocardiography. CONCLUSIONS: Among patients with rheumatic heart disease undergoing MVR without concomitant tricuspid valve repair, independent predictors for new severe TR were preoperative moderate TR and AF. New severe TR was associated with increased furosemide use.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Cardiopatia Reumática/cirurgia , Insuficiência da Valva Tricúspide/fisiopatologia , Valva Tricúspide/fisiopatologia , Adulto , Distribuição de Qui-Quadrado , Progressão da Doença , Ecocardiografia Doppler , Feminino , Furosemida/uso terapêutico , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Modelos de Riscos Proporcionais , Cardiopatia Reumática/diagnóstico por imagem , Cardiopatia Reumática/mortalidade , Cardiopatia Reumática/fisiopatologia , Fatores de Risco , Índice de Gravidade de Doença , Inibidores de Simportadores de Cloreto de Sódio e Potássio/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/mortalidade
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