April 2, 2016
New clinical analysis shows Novartis’ Entresto™ reduced cardiovascular (CV) death or hospitalization for heart failure, steadily benefitting patients with reduced ejection fraction (HFrEF) regardless of prior hospital admissions due to heart failure or background therapy. The analysis showed that Entresto benefited patients considered clinically stable, with no history or only a remote history of prior heart failure hospitalization, just as much as it did those who were least-stable (hospitalization for heart failure within 3 months of baseline).
In a second analysis, patients taking Entresto™ (sacubitril/valsartan) tablets had about a 20% reduction in cardiovascular death or heart failure hospitalization compared to those who took enalapril, regardless of background therapy.
The analyses are of data from PARADIGM-HF, the largest clinical trial ever conducted in heart failure. It compared Entresto to ACE inhibitor enalapril, and the results are being presented at the 65th Annual Scientific Session in Chicago, organized by American College of Cardiology.
“In PARADIGM-HF, about half of primary events among stable patients were cardiovascular death. This indicates that the full spectrum of patient types we studied in the trial may be at risk for adverse outcomes due to the disease. In fact, the analyses make a case that patients we consider clinically stable, as well as those who are already being treated with guideline-directed background therapy may benefit from sacubitril/valsartan,” said Scott Solomon, MD, Director of Noninvasive Cardiology, Brigham and Women’s Hospital and Professor of Medicine, Harvard Medical School.
The clinical outcomes also showed that more than one third of patients were recognized as clinically stable, and 20% of those experienced a primary endpoint event (heart failure hospitalization or cardiovascular death). Among these patients, 51% suffered CV death as their first event. Moreover, the analysis determined that Entresto benefited patients who were considered clinically stable just as much as it did those who were least-stable (hospitalization due to heart failure within 3 months of baseline). Among both groups, patients taking Entresto had a 20% or greater reduction in CV death or heart failure hospitalization compared to those who took enalapril.
“We’re encouraged by these new analyses for Entresto. The positive results add to the already robust evidence that shows the potential benefits this medicine can offer heart failure patients with reduced ejection fraction. What’s important is that these data can translate into real-world impact by giving doctors, nurses and other healthcare providers a much needed medicine to help more of their patients better manage this debilitating and life-threatening condition,” said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation.