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Entresto Data Show Long-Term Benefits on Heart Failure Readmissions
The results of a new analysis have demonstrated that Entresto (sacubitril/valsartan, Novartis) reduced the risk of all events––first and repeat heart failure (HF) hospitalizations as well as cardiovascular (CV) deaths that followed HF hospitalization––compared with enalapril in heart failure patients with a reduced ejection fraction (HFrEF). The findings are from a post hoc analysis of PARADIGM-HF, the largest clinical trial ever conducted in HF.
Investigators analyzed all heart failure hospitalizations and all CV deaths that occurred during the PARADIGM-HF trial. A total of 3,181 primary endpoint events (including 1,251 CV deaths) were observed during the median 27-month double-blind follow-up period. Approximately one-third of the patients with a primary event also experienced a repeat event (defined as repeat HF hospitalizations or a CV death that followed HF hospitalization).
Using statistical analysis models, the investigators found that Entresto demonstrated a risk reduction of between 20% and 24% for all events (first-time and repeat events) compared with enalapril. These findings were consistent with the ability of Entresto to reduce the risk of a first event in the PARADIGM-HF study (i.e., a 20% risk reduction compared with enalapril on the primary endpoint, a composite measure of the time to CV death or first HF hospitalization).
Additional post hoc analyses from the PARADIGM-HF study further supported the efficacy and safety of Entresto in a range of HFrEF patients compared with enalapril. These analyses found:
- Treatment with Entresto was associated with fewer diuretic dose increases and more dose reductions compared with enalapril.
- Patients receiving Entresto and a mineralocorticoid receptor antagonist (MRA) had a lower risk of severe hyperkalemia compared with those receiving enalapril and an MRA.
- Entresto showed a consistent benefit in patients with severe HF symptoms (New York Heart Association functional class IV).
Entresto is a twice-daily medication that reduces the strain on the failing heart. It does this by enhancing the protective natriuretic peptide system while inhibiting the harmful effects of the overactive renin–angiotensin–aldosterone system (RAAS). Other heart failure drugs block only the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.
Source: Novartis; November 15, 2016.