Novartis’ heart failure drug Entresto can be initiated early in hospitalized patients

Swiss drugmaker Novartis unveiled new data on Entresto (sacubitril/valsartan) from a phase 4 study which confirms that the heart failure drug can be initiated early and safely across a broad range of heart failure patients with reduced ejection fraction (HFrEF), whose condition has been stabilized following hospitalization because of an acute heart failure episode.

In the phase 4 study called TRANSITION, Entresto safety and tolerability was evaluated in HFrEF patients who were stabilized after an acute heart failure episode.

Patients enrolled in the trial were those without any prior experience of Entresto or conventional HF therapies, and also those who had prior experience of conventional HF therapies.

TRANSITION randomly grouped the patients to be initiated with Entresto heart failure drug in the hospital or shortly after their discharge from hospital. At 10 weeks, over 86% of patients were subjected to Entresto for two weeks or more without interruption and nearly half of patients in the TRANSITION trial achieved the primary endpoint which was a target dose of 200 mg of Entresto daily twice within 10 weeks in both the patient arms.

Novartis said that the number of patients who achieved the primary and secondary endpoints was identical across both treatment groups. The Swiss pharma company also said that incidence of adverse events and discontinuations of its heart failure drug because of adverse events were also on par with the in-hospital and also with the out-patient setting.

Prof. Rolf Wachter – University Hospital Leipzig, Germany and TRANSITION study investigator said: “In the weeks following an episode of acute heart failure, patients are very vulnerable and face a high risk of re-hospitalization and death.

“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 has been designed to bring down the strain on the failing heart which it does by improving the protective neurohormonal systems while at the same time preventing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS).

Shreeram Aradhye – Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals, commenting on the company’s heart failure drug said: “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. 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.”

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