Nine New Analyses Show Novartis' LCZ696 Could Change Course of Heart Failure for Patients

New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients. In August 2014 Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalisation.

The new analyses being presented for the first time at the American Heart Association Scientific Sessions 2014, with a paper being simultaneously published in Circulation, show that versus enalapril, LCZ696 significantly:

• reduced the risk of dying suddenly by 20% — in HFrEF patients 45% of CV deaths and 36% of all cause deaths are sudden
• reduced first and subsequent HFrEF hospitalisations by 21% and 23% respectively
• reduced hospitalisations for a cardiovascular reason or for any reason both by 16%
• reduced the need for more intense treatment at home by 16%
• reduced emergency room visits because of rapid symptom worsening by 30%.

When hospitalised, LCZ696 and enalapril patients remained under care for approximately the same time, but those on LCZ696 had 18% fewer stays in intensive care and were 31% less likely to need IV drugs to help their heart pump. Patients' reports of how well they felt and doctors' assessments of disease severity were also significantly better with LCZ696 than enalapril.

"These results provide strong evidence that we may be able to do more than reduce risk of death or hospitalisation with LCZ696 versus enalapril. This therapy offers hope to millions of people living with HFrEF that they can also reduce or slow the decline in their heart function, potentially altering the progression of their disease," said David Epstein, Division Head, Novartis Pharmaceuticals.

Analysis of cardiac biomarkers (NTpro-BNP and troponin), substances that indicate the progression of cardiac disease and risk, showed levels were consistently lower with LCZ696 than enalapril, reflecting reduced heart stress and subsequent damage.

LCZ696, a twice a day medicine being investigated for heart failure, acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS). Currently available medicines for HFrEF only block the harmful effects and mortality remains very high with up to 50% of patients dying within 5 years of a diagnosis of heart failure.

Novartis plans to complete the file for marketing authorisation with the US FDA by the end of 2014 and in the European Union in early 2015.