Novartis (NVS) Announces Strong Data on Entresto in Heart Event Risk Reduction for HFrEF-Related Heart Failure Patients

November 15, 2016 1:06 PM EST

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Novartis (NYSE: NVS) announced results of a new analysis demonstrating that Entresto® (sacubitril/valsartan) tablets reduced the risk of all events - first and repeat heart failure (HF) hospitalizations as well as cardiovascular (CV) deaths that followed HF hospitalization - compared to enalapril among heart failure patients with reduced ejection fraction (HFrEF).[1] The findings are from a post-hoc analysis of PARADIGM-HF, the largest clinical trial ever conducted in HF,[6] and are being presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans.

"In PARADIGM-HF, about one-third of heart failure patients with a first event experienced subsequent events - underscoring the substantial risks faced by patients with this life-threatening condition," said Professor John McMurray of the University of Glasgow, and co-principal investigator for PARADIGM-HF. "The fact that sacubitril/valsartan not only reduced the risk of a first event, but also of repeat events - which are at least as serious and costly, and all too common - is highly significant and reinforces why this medicine is now guideline-directed therapy."

Investigators conducted a comprehensive analysis of all heart failure hospitalizations and all CV deaths that took place in the PARADIGM-HF trial. A total of 3,181 primary endpoint events (including 1,251 CV deaths) were observed during the median 27-month double-blinded follow-up period of PARADIGM-HF, and about one-third of patients with a primary event also experienced a repeat event (defined as repeat HF hospitalizations or a CV death that followed HF hospitalization). Using multiple statistical analysis models, investigators found that Entresto demonstrated a risk reduction of between 20%-24% for all events (first-time and repeat events) compared to enalapril.[1] These findings are consistent with the proven benefit of Entresto for reducing the risk of a first event in PARADIGM-HF (a 20% risk reduction compared to enalapril on the primary endpoint, a composite measure of time to CV death or first HF hospitalization).[1],[2]

"These analyses further support our knowledge that Entresto can keep many heart failure patients with reduced ejection fraction alive and out of the hospital for longer," said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. "As we continue to analyze the results of the PARADIGM-HF study, we become more and more confident in the benefit that Entresto can bring to patients and to potentially reducing costs of care to healthcare systems."

Additional post-hoc analyses from PARADIGM-HF also presented at AHA Scientific Sessions further support the efficacy and safety benefits of Entresto among a range of HFrEF patients compared to enalapril.[3],[4],[5] These analyses found:

Treatment with Entresto was associated with fewer diuretic dose increases and more dose reductions compared to enalapril.[3]
Patients receiving Entresto and a mineralocorticoid receptor antagonist (MRA) had a lower risk of severe hyperkalemia (high potassium levels, >6) compared to those taking enalapril and an MRA.[4]
In patients with severe HF symptoms (NYHA functional class IV), Entresto showed consistent benefit when compared to the overall patient population of PARADIGM-HF.[5]

About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts over 60 million people worldwide.[7] It is the leading cause of hospitalization in people over the age of 65.[8],[9] About half of people with heart failure have heart failure with reduced ejection fraction (HFrEF).[10] Reduced ejection fraction means the heart does not contract with enough force, so less blood is pumped out.[11] Heart failure presents a major and growing health-economic burden that currently costs the world economy $108 billion every year, which accounts for both direct and indirect costs.[8],[12]

Novartis has established the largest global clinical program in the heart failure disease area across the pharma industry to date, FortiHFy, comprising over 40 active or planned clinical studies designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real world evidence with Entresto, as well as to extend understanding of heart failure.

[1] McMurray JJV, Packer M, Desai A, et al. Analysis of Recurrent (Including First and Repeat) Primary Endpoint Events (Composite of Heart Failure hospitalizations and Cardiovascular Death) in PARADIGM-HF. American Heart Association Scientific Sessions 2016; New Orleans, LA, USA.
[2] McMurray JJV, Packer M, Desai AS, et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure. N Engl J Med. 2014; 371:993-1004. doi: 10.1056/NEJMoa1409077.
[3] Vardeny O, et al. Reduced loop diuretic use in patients taking sacubitril/valsartan compared with enalapril: The PARADIGM-HF study. American Heart Association Scientific Sessions 2016; New Orleans, LA, USA.
[4] Solomon S, Packer M, Claggett B, et al. Reduced Risk of Hyperkalemia in Heart Failure Patients Treated with an MRA and Sacubitril/Valsartan Compared with Enalapril: The PARADIGM-HF Trial. American Heart Association Scientific Sessions 2016; New Orleans, LA, USA.
[5] McMurray JJV, Gong J, Rouleau J, et al. Efficacy and safety of sacubitril/valsartan in patients in NYHA functional class IV. An analysis of PARADIGM-HF. American Heart Association Scientific Sessions 2016; New Orleans, LA, USA.
[6] McMurray JJV, Packer M, Desai AS, et al. Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF). Eur J Heart Fail. 2014; 16(7):817-25.
[7] Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013, Lancet 2015
[8] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A report from the American Heart Association. Circulation. 2015; 133; e38-e360. doi: 10.1161/CIR.0000000000000350.
[9] Weir LM, Pfuntner A, Maeda J, et al. HCUP facts and figures: statistics on hospital-based care in the United States, 2009. Rockville, MD: Agency for Healthcare Research and Quality, 2011.
[10] Owan TE, Hodge DO, Herges RM, et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259.
[11] Ejection Fraction Heart Failure Measurement. American Heart Association Website. (link is external) (link is external). Published March 24, 2015. Accessed October 10, 2016.
[12] Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013; 6:606-619.
[13] Entresto Prescribing Information
[14] Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discovery Today. 2012:4: e131-9.
[15] Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines. Circulation. 2013; 128: e240-e327.

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