New data revealing the reduction in cardiovascular deaths with Novartis’ LCZ696 in patients with heart failure with reduced ejection fraction (HF-REF) will be presented at the European Society of Cardiology (ESC) Congress 2014, on Sunday 31 August. The study assessing LCZ696 (PARADIGM-HF) met the primary endpoint showing reduced heart failure hospitalisations and reduced cardiovascular deaths.
PARADIGM-HF, included 8,442 patients and was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March 2014 the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from cardiovascular causes, leading to the trial being closed early.
Over five million people suffer from heart failure in the United States, facing a high risk of death and poor quality of life, despite currently available medicines. As a serious condition with an urgent need for new treatments, the FDA has granted LCZ696 Fast Track designation, which can expedite the review of new medicines intended to treat serious or life-threatening conditions. Fast Track designation also allows for rolling submission in the USA, which Novartis expects to complete by the end of 2014.
The scientific presentation at the ESC Congress 2014 will include safety data from the study showing LCZ696 was well-tolerated and side effects manageable. Ten further presentations throughout the ESC Congress 2014 will provide a wider overview of Novartis’s ongoing research in heart failure and other areas of cardiology.
Novartis presentations on LCZ696 at ESC include:
- Seven abstracts (two oral presentations and five posters):
– Results of the prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF) (#881), M Packer – Hot Line: Cardiovascular disease: novel therapies – Sunday 31 August, 08:30 – 10:20 (08:30 – 08:45)
– Results of the prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF) (#1115), J McMurray, M Packer – Meet the trialist I: PARADIGM-HF – Sunday 31 August, 10:10 – 10:50 (10:10)
– High prevalence of elevated high sensitivity troponin-T and reduction in levels by LCZ696 in heart failure with preserved ejection fraction in the PARAMOUNT trial (#P5847), P S Jhund – Moderated Posters: Defining prognosis in heart failure with preserved ejection fraction – Tuesday 2 September, 15:30 – 16:30 (15:55)
