ARNI can be initiated early and safely in hospitalized patients after acute HF episode

News - Sep. 3, 2018

Data from the TRANSITION study presented at the European Society of Cardiology (ESC) Congress in Munich, Germany show that sacubitril/valsartan can be initiated early and safely in a wide range of heart failure patients with reduced ejection fraction (HFrEF) who have been stabilized after hospitalization due to an acute heart failure (HF) episode. The primary and secondary endpoints of the of number of patients achieving the target dose of sacubitril/valsartan of 200 mg twice daily (bid) at week 10 (regardless of previous dose interruption or down-titration), and number of patients maintaining 100 mg or 200 mg bid for at least two weeks leading to week 10 after randomization, respectively, occurred at a similar rate in patients who had and had not been exposed to an ACEi/ARB previously. The incidence of adverse events and discontinuations of sacubitril/valsartan due to adverse events was also similar in the in-hospital and the out-patient setting.

TRANSITION was a randomized, phase IV, multicenter, open-label, parallel-group study, which assessed the safety and tolerability of sacubitril/valsartan in 1,002 HFrEF patients, from 156 hospitals worldwide, after stabilization following hospitalization for acute HF, when treatment was started in hospital (pre-discharge) or shortly after leaving hospital (post-discharge). Patients were grouped based on their pre-admission treatment status: those who were receiving an ACEI or an ARB, and those with no prior experience with an ACEI/ARB. Following screening and randomization to sacubitril/valsartan, the study comprised a 10 week treatment period followed by a 16 week follow-up phase.

Sacubitril/valsartan is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). In Europe, sacubitril/valsartan is indicated in adult patients for the treatment of symptomatic chronic HFrEF. In the United States, it is indicated for the treatment of heart failure (New York Heart Association class II-IV) in patients with systolic dysfunction.

Source: Press release Novartis, August 25, 2018

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