August 25, 2014 — New data revealing the reduction in cardiovascular (CV) deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction (HF-REF) will be presented at the world's largest cardiology congress, the European Society of Cardiology (ESC) Congress 2014, on Sunday, Aug. 31 at 2:30 a.m. EDT. The data will also be highlighted in the official ESC press conference on Saturday, Aug. 30 at 7 a.m. EDT. The study met the primary endpoint showing LCZ696 reduced heart failure hospitalizations along with CV deaths.
The 8,442-patient study, PARADIGM-HF, 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 CV causes, leading to the trial being closed early.
More than 5 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 [4,5,6]. As a serious condition with an urgent need for new treatments, the U.S. Food and Drug Administration (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 United States, 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, Aug 31, 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, Aug. 31, 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, Sept. 2, 15:30-16:30 (15:55)
1. Clinicaltrials.gov. This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure (PARADIGM-HF). NCT01035255. http://clinicaltrials.gov/ct2/show/NCT01035255. Accessed July 29, 2014.
2. Novartis. PARADIGM-HF trial of Novartis' LCZ696 for chronic heart failure closes early based on strength of interim results. Novartis U.S. Newsroom. March 31, 2014. http://www.novartis.com/newsroom/media-releases/en/2014/1772754.shtml. Accessed July 31, 2014.
3. Novartis. Novartis maintained strong innovation momentum in second quarter, while reconfirming full year outlook. Media Release. July 2014. http://www.novartis.com/newsroom/media-releases/en/2014/1828193.shtml. Accessed July 31, 2014.
4. Go A, Mozaffarian D, Roger V, et al. Heart Disease and Stroke Statistics??2014 Update: A Report From the American Heart Association. Circulation. 2014, 4; 129: e28-e292.
5. Junger J, Schellberg D, Kraemer S, et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002; 87(3): 235-241.
6. Tomaselli G, Zipes D. What causes sudden death in heart failure? Circulation Research. 2004; 95(8): 754-763.
For more information: www.novartis.com