Paradigm-HF: a Paradigm Shift in Heart Failure Treatment?
نویسندگان
چکیده
DOI: 10.5935/abc.20160009 In the first semester of this year, the U.S. Food and Drug Administration (FDA) approved a new drug for the treatment of heart failure, LCZ696, commercially known as Entresto. This new treatment option was evaluated by the FDA on a priority basis (fast track designation), which allowed a faster release than usual. In Brazil, the drug is being evaluated by the National Health Surveillance Agency (Agência Nacional de Vigilância SanitáriaANVISA), similarly to what occurs in Canada and the European Union countries.
منابع مشابه
Factors Associated With Noncompletion During the Run-In Period Before Randomization and Influence on the Estimated Benefit of LCZ696 in the PARADIGM-HF Trial
Although randomized controlled trials represent the “gold standard” for assessment of comparative efficacy, there are frequent concerns about the generalizability of the results to the broader population of patients seen in clinical practice. In the Prospective Comparison of ARNI With an AngiotensinConverting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failur...
متن کاملBaseline characteristics and treatment of patients in Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF)
AIM To describe the baseline characteristics and treatment of the patients randomized in the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and morbidity in Heart Failure) trial, testing the hypothesis that the strategy of simultaneously blocking the renin-angiotensin-aldosterone system and augmenting natriuretic peptides with LCZ696 200 mg b.i.d. ...
متن کاملHypochloremia and Diuretic Resistance in Heart Failure
The fundamental role of sodium in maintenance of fluid homeostasis and progression of heart failure (HF) has been a central paradigm in medicine for more than a century. As a result, a core treatment principal in HF management has been the avoidance of dietary sodium. However, accumulating evidence ranging from the basic sciences to epidemiological studies has challenged this paradigm, suggesti...
متن کاملSafety I to Safety II: A Paradigm Shift or More Work as Imagined?; Comment on “False Dawns and New Horizons in Patient Safety Research and Practice”
In their editorial, Mannion and Braithwaite contend that the approach to solving the problem of unsafe care, Safety I, is flawed and requires a shift in thinking to what they are calling Safety II. We have reservations as to whether by itself the shift from Safety I to Safety II is sufficient. Perhaps our failure to improve outcomes in the field of patient safety and quality lies less in our ap...
متن کاملEffect of sacubitril/valsartan on recurrent events in the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF).
AIMS Recurrent hospitalizations are a major part of the disease burden in heart failure (HF), but conventional analyses consider only the first event. We compared the effect of sacubitril/valsartan vs. enalapril on recurrent events, incorporating all HF hospitalizations and cardiovascular (CV) deaths in PARADIGM-HF, using a variety of statistical approaches advocated for this type of analysis. ...
متن کامل