Entresto Initiation Soon After Acute HF Episode Safe in HFrEF Patients
Treatment with Entresto (sacubitril/valsartan; Novartis) can be started early and safely in heart failure patients with reduced ejection fraction (HFrEF) who have been stabilized after hospitalization due to an acute heart failure episode, according to research presented at the European Society of Cardiology (ESC) Congress.
The Phase 4, randomized, open-label, parallel-group TRANSITION study (N=1002) evaluated the safety and tolerability of Entresto in HFrEF patients after they were stabilized following an acute heart failure episode when treatment was initiated either pre-discharge or post-discharge; the study included patients with prior experience with conventional heart failure therapies and those with no previous experience. The primary endpoint was the percentage of patients achieving the target dose of Entresto 200mg twice daily at week 10 (regardless of previous dose interruption or down-titration). The secondary endpoint was the number of patients maintaining 100mg or 200mg twice daily for ≥2 weeks leading to week 10 after randomization.
Results showed that at week 10, over 86% of patients were receiving Entresto for ≥2 weeks without interruption, and about 50% of patients in the study achieved the primary endpoint; across both treatment arms, the number of patients who met the primary and secondary endpoints was similar. Rates of adverse events and treatment discontinuations were similar in both the in-hospital and outpatient settings.
Study investigator, Professor Rolf Wachter, University Hospital Leipzig, Germany, stated, "The PARADIGM-HF study showed that sacubitril/valsartan reduces heart failure-related hospitalizations, re-hospitalization and death. TRANSITION shows that sacubitril/valsartan can be initiated early and safely in patients shortly after an acute heart failure episode, providing physicians with added confidence to optimize their care with innovative medicines in heart failure treatment."
Entresto, which combines a neprilysin inhibitor and an angiotensin II receptor blocker (ARB), is currently approved to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II–IV) and reduced ejection fraction. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
Entresto is available as 24mg/26mg, 49mg/51mg, and 97mg/103mg strength tablets.
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