Novartis announces new data that show Entresto® (sacubitril/valsartan) can be initiated early & safely in hospitalized patients after an acute heart failure episode - Seite 2

In TRANSITION, the safety and tolerability of Entresto were assessed in HFrEF patients after they have been stabilized following an acute heart failure episode. Patients were randomized to initiate Entresto therapy either in the hospital (pre-discharge) or shortly after leaving the hospital (post-discharge)[1]. At 10 weeks, more than 86% of patients were receiving Entresto for 2 weeks or longer without interruption and about half of patients in the study achieved the primary endpoint which was a target dose of 200 mg of Entresto twice daily within 10 weeks in both groups[1]. The number of patients who met the primary and secondary endpoints was similar across both treatment arms[1]. The incidence of adverse events and discontinuations of Entresto due to adverse events was also similar in both the in-hospital and the out-patient setting[1].

"We are encouraged by the findings of TRANSITION which show that Entresto, the new standard of care in heart failure, can be safely initiated in recently hospitalized patients," said Shreeram Aradhye, MD, Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "Heart failure is a serious progressive disease with 83% of patients hospitalized at least once for an acute heart failure episode during the course of their condition. Hospitalization provides an opportunity for physicians to optimize heart failure treatment according to guidelines to reduce the likelihood of hospital readmission and death, reduce the burden of hospitalizations, and improve patient outcomes."

About TRANSITION
TRANSITION (NCT02661217) is a randomized, phase IV, multicenter, open-label, parallel-group study, which assessed the safety and tolerability of Entresto in 1,002 HFrEF patients, from 156 hospitals worldwide, after stabilization following hospitalization for acute heart failure, when treatment was started in hospital (pre-discharge) or shortly after leaving hospital (post-discharge)[1],[9]. Patients were grouped based on their pre-admission treatment status: those who were receiving an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB), or those with no prior experience with an ACEI/ARB. Following screening and randomization to Entresto, the study comprised a 10 week treatment period followed by a 16 week follow-up phase. The primary and secondary endpoints were the number of patients achieving the target dose of Entresto 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[1],[9]. The study protocol took into account the needs of the practicing cardiologists, and enabled investigators to select the appropriate starting dose of Entresto and dose adjustments due to clinical circumstances, allowing for differences between international hospitals and healthcare settings[9].