Novartis reveals positive results from Entresto Phase 4 TRANSITION study for heart failure patients

Swiss pharmaceutical giant Novartis has announced encouraging results from the TRANSITION phase 4 clinical trial, affirming that Entresto (sacubitril/valsartan) can be safely initiated early in a broad range of patients with heart failure with reduced ejection fraction (HFrEF), shortly after stabilization from an acute heart failure episode. This groundbreaking study underlines the effectiveness of Entresto across diverse patient backgrounds, either previously untreated or treated with conventional heart failure therapies.

The TRANSITION study specifically looked at the safety and tolerability of initiating Entresto in patients stabilized after an acute heart failure episode. Patients were either started on Entresto while still in the hospital or shortly after discharge. Remarkably, after 10 weeks, over 86% of the participants continued with the treatment uninterrupted for two weeks or more, and nearly half achieved the primary endpoint of reaching a target dose of 200 mg twice daily.

Notably, the results indicated no significant difference in the achievement of primary and secondary endpoints between the in-hospital and outpatient initiation groups. This suggests that early administration of Entresto is equally effective in both settings. The incidence of adverse events and the discontinuation rates due to these events were comparable across both groups, reinforcing the drug’s tolerability.

Professor Rolf Wachter from the University Hospital Leipzig, Germany, and an investigator in the TRANSITION study, highlighted the vulnerability of patients following an acute heart failure episode, emphasizing the high risk of re-hospitalization and mortality. He stated, “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.”

Shreeram Aradhye, Chief Medical Officer and Global Head of Medical Affairs at Novartis Pharmaceuticals, commented on the potential of Entresto to set a new standard of care in heart failure management. He pointed out the critical opportunity hospitalization provides to optimize treatment to prevent future hospital readmissions and improve patient outcomes.

The TRANSITION trial results are a significant endorsement for early initiation of Entresto in heart failure management. This approach could potentially transform the treatment paradigm, offering a proactive strategy that could reduce hospital readmissions and improve long-term patient outcomes in heart failure care.