IMPORTANCE Sodium glucose cotransporter 2 inhibitors reduce morbidity and mortality in patients with heart failure and reduced ejection fraction (HFrEF). Clinicians may find estimates of the projected long-term benefits of sodium glucose cotransporter 2 inhibitors a helpful addition to clinical trial results when communicating the benefits of this class of drug to patients. OBJECTIVE To estimate the projected long-term treatment effects of dapagliflozin in patients with HFrEF over the duration of a patient's lifetime.DESIGN, SETTING, AND PARTICIPANTS Exploratory analysis was performed of Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF), a phase 3 randomized, placebo-controlled clinical trial conducted at 410 sites in 20 countries. Patients with an ejection fraction less than or equal to 40% in New York Heart Association functional classification II to IV and elevated plasma levels of N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019. Mean (SD) duration of follow-up was 17.6 (5.2) months.INTERVENTIONS Dapagliflozin, 10 mg, once daily vs placebo in addition to standard therapy.
MAIN OUTCOMES AND MEASURESThe primary composite outcome was time to first hospitalization for heart failure, urgent heart failure visit requiring intravenous therapy, or cardiovascular death. The trial results were extrapolated to estimate the projected long-term treatment effects of dapagliflozin over the duration of a patient's lifetime for the primary outcome and the secondary outcome of death from any cause.RESULTS A total of 4744 patients (1109 women [23.4%]; 3635 men [76.6%]) were randomized in DAPA-HF, with a mean (SD) age of 66.3 (10.9) years. The extrapolated mean event-free survival for an individual aged 65 years from a primary composite end point event was 6.2 years for placebo and 8.3 years for dapagliflozin, representing an event-free survival time gain of 2.1 years (95% CI, 0.8-3.3 years; P = .002). When considering death from any cause, mean extrapolated life expectancy for an individual aged 65 years was 9.1 years for placebo and 10.8 years for dapagliflozin, with a gain in survival of 1.7 years (95% CI, 0.1-3.3; P = .03) with dapagliflozin. Similar results were seen when extrapolated across the age range studied. In analyses of subgroups of patients in DAPA-HF, consistent benefits were seen with dapagliflozin on both event-free and overall survival.
CONCLUSIONS AND RELEVANCEThese findings indicate that dapagliflozin provides clinically meaningful gains in extrapolated event-free and overall survival. These findings may be helpful in communicating the benefits of this treatment to patients with HFrEF.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03036124
Objective: To evaluate the impact of autologous hematopoetic stem cell transplantation (autoHSCT) in the health related quality of life (HRQL) in patients with multiple sclerosis. Method: The sample consisted of 34 patients, over 18 years old, treated at a University Hospital in the state of São Paulo, Brazil. For data collection MOS SF-36 and EDSS scales were applied at three time points: admission of the patient, hospital discharge and 1 year posttransplantation. Results: 27 patients (79%) showed stabilization or neurological improvement 1 year posttransplantation. At this time point, there was statistically significant improvement in all domains of the HRQoL. When EDSS scores were correlated with the domains of the MOS SF-36 scale, statistically significant correlations were found with physical functioning at the three time points analysed. Conclusion: In spite of the high risk of complications of the procedure, the HSCT had positive impact in the health related quality of life. Key words: quality of life, multiple sclerosis, bone marrow transplantation.Impacto do transplante autólogo de células-tronco hematopoéticas na qualidade de vida de pacientes com esclerose múltipla RESUMO Objetivo: Avaliar o impacto do transplante de células-tronco hematopoéticas (TCTH) na qualidade de vida relacionada à saúde (QVRS) de pacientes com esclerose múltipla (EM). Método: A amostra foi composta por 34 sujeitos, maiores de 18 anos, atendidos em um hospital-escola do interior do Estado de São Paulo, Brasil. Para coleta de dados foram aplicados os instrumentos MOS SF-36 e EDSS. Resultados: 27 (79%) sujeitos apresentaram estabilização ou melhora neurológica um ano após o TCTH. Decorrido um ano do procedimento, houve melhora estatisticamente significativa em todos os domínios da QVRS. Ao relacionar os escores da EDSS com os domínios do MOS SF-36, foram encontradas diferenças estatisticamente significantes na Funcionalidade nos três momentos do TCTH. Conclusão: Apesar do elevado risco de complicações, pode-se afirmar que o TCTH repercutiu positivamente na apreciação que o paciente faz de sua QVRS. Palavras-chave: qualidade de vida, esclerose múltipla, transplante de medula óssea.
Correspondence
Objective: To determine whether the benefits of dapagliflozin in patients with heart failure and reduced ejection fraction (HFrEF) and type 2 diabetes in DAPA-HF varied by background glucose-lowering therapy (GLT). Research design and methods: We examined the effect of study treatment by the use or not of GLT, and by GLT classes and combinations. The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death. Results: In the 2139 type 2 diabetes patients, the effect of dapagliflozin on the primary outcome was consistent by GLT use/no use (hazard ratio 0.72 [95%CI 0.58-0.88] versus 0.86 [0.60-1.23]; P-interaction=0.39) and across GLT classes. Conclusions: In DAPA-HF, dapagliflozin improved outcomes irrespective of use/no use of GLT or by GLT type used in patients with type 2 diabetes and HFrEF.
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