Novartis says Entresto outperforms heart failure drug enalapril in key study

Novartis presented study data at the American Heart Association's (AHA) scientific sessions showing that Entresto (sacubitril/valsartan) outperformed enalapril in patients with heart failure with reduced ejection fraction requiring hospitalisation for an acute decompensation heart failure event.

Results illustrated that Entresto was associated with a 29-percent decline in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at four weeks and eight weeks versus enalapril, meeting the PIONEER-HF trial's primary endpoint. Chief medical officer Shreeram Aradhye remarked "together with data from the PARADIGM-HFstudy, which demonstrated the superior benefit of Entresto compared to an ACE [inhibitor] on cardiovascular mortality and HF hospitalisations in ambulatory patients, there is now consistent evidence in the in- and outpatient settings supporting the use of Entresto."  

In the study, 881 hospitalised patients aged 18 and older with reduced ejection fraction and elevated NT-proBNP levels were randomly assigned to treatment with Entresto or enalapril. The primary endpoint was the time-averaged proportional change in NT-proBNP from baseline at four weeks and eight weeks, while safety outcomes included rates of angio-oedema, hyperkalaemia, symptomatic hypotension and worsening renal function. 

According to study results, significant reductions in NT-proBNP levels in favour of Entresto were seen as early as after one week of treatment. Meanwhile, rates of serious adverse events were similar between the treatment arms. 

Entresto has been cleared in the US and EU to reduce the risk of cardiovascular death and heart failure hospitalisations among patients with heart failure and reduced ejection fraction. Sales of the therapy in the third quarter more than doubled versus the prior-year period to $271 million.