Optimal use of Novartis heart failure treatment (Pr)Entresto™ could save more than 3,000 lives in Canada each year according to a new analysis(1)

DORVAL, QC, March 9, 2017 /CNW/ - Findings from a new analysis suggest that a substantial number of deaths in Canada could potentially be avoided with optimal usage of the Novartis Pharmaceuticals Canada Inc. (Novartis) heart failure treatment Entresto™ (sacubitril/valsartan).¹ The results of the analysis were presented this week by the authors at the EPI-Lifestyle 2017 Scientific Sessions of the American Heart Association in Portland, Oregon.

The new Canadian analysis evaluated the potential number of deaths that could be prevented with optimal usage of Entresto™ per the approved indication in Canada. The number of patients who need to be treated to avoid one death was calculated from the PARADIGM-HF trial, the pivotal study that led to the approval of Entresto™.² The analysis estimated that 242,200 patients in Canada are affected with NYHA (New York Heart Association) class II and III heart failure with reduced ejection fraction and concluded that treatment with Entresto™ could prevent 3,014 patient deaths per year (range 1,930-4,331).¹

"The findings of the analysis demonstrate the potential benefit that broad clinical use of Entresto™ could have for Canadian heart failure patients," said the analysis' lead author, Dr. Robert McKelvie, Heart Failure Specialist, Professor of Medicine, Division of Cardiology, Schulich School of Medicine and Dentistry, Western University, St. Joseph's Health Care Centre, London, Ontario. "In the right patients, this could not only prevent deaths but also prevent hospitalizations. Heart failure is one of the leading causes of hospitalization for Canadians and reducing hospitalization rates could help bring important benefits to our health system."

Heart failure is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life.³ About half of heart failure patients have a reduced ejection fraction, a measurement that defines how well the heart is pumping blood.^4,5

Entresto™ is indicated for the treatment of heart failure with reduced ejection fraction in patients with NYHA Class II or III heart failure to reduce the incidence of cardiovascular death and heart failure hospitalization.⁶

"Heart failure affects one in every five Canadians and places a heavy burden on the patients' families," said Dawn Bell, Chief Scientific Officer and Vice President, Medical Affairs at Novartis Pharmaceuticals Canada Inc. "This analysis applied data from the PARADIGM-HF trial to a real-world population of Canadian heart failure patients in order to determine the potential impact of Entresto™ in clinical practice."

About heart failure in Canada
More than 600,000 Canadians have heart failure⁷ and it is responsible for 9% of all deaths in Canada, or about 22,000 per year,⁸ which is almost equal to the number of deaths from breast, colorectal, prostate and pancreatic cancer combined.⁹ It is the second leading cause of hospitalization in Canada for patients over 65¹⁰ and resulted in estimated direct costs of $2.89 billion in 2012.¹¹

About Entresto™
Entresto™ is a first-in-class medicine containing sacubitril, a neutral endopeptidase inhibitor and valsartan, an angiotensin II AT₁ receptor blocker. A twice-a-day tablet, it has a unique mode of action impacting the neurohormonal systems of the heart. It is thought to reduce the strain of the failing heart by enhancing the protective natriuretic peptide system while simultaneously suppressing the compensatory renin–angiotensin–aldosterone system which can be harmful over time.^12,13,14

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2015, the company invested $53 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs more than 700 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Entresto is a trademark of Novartis Pharmaceuticals Canada Inc.

_______________________________
^1	McKelvie R et al, Potential mortality reduction with optimal usage of sacubitril/valsartan therapy for the treatment of heart failure in Canada, abstract presented at EPI-Lifestyle, American Heart Association, March 2017.
^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	Fauci A, Longo D. Disorders of the Heart. Harrison's Principles of Internal Medicine. 17th ed. 2008; 4:1442-55.
^4	American Heart Association, heart.org, Ejection Fraction Heart Failure Measurement, accessed at: http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFailure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp#.
^5	Owan TE et al, Trends in Prevalence and Outcome of Heart Failure with Preserved Ejection Fraction, N Engl J Med 2006; 355:251-259July 20, 2006DOI: 10.1056/NEJMoa052256.
^6	Novartis Pharmaceuticals Canada Inc., Entresto Product Monograph, Indications and Clinical Use, August 3, 2016, p. 3.
^7	Blais C, et al. Assessing the burden of hospitalized and community-care heart failure in Canada. Can J Cardiol. 2014 Mar; 30(3):352-8 and Statistics Canada, Population by sex and age group, 2013, accessed at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo10a-eng.htm.
^8	Brophy JM. Epidemiology of congestive heart failure: Canadian data from 1970 to 1989. Can J Cardiol 1992;8:495-498 and Statistics Canada, Leading Causes of deaths in Canada, CANSIM Table 102-0561 at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/hlth36a-eng.htm.
^9	Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2016, p.50, Toronto: Canadian Cancer Society; 2016.
^10	Canadian Institute for Health Information (CIHI), A Snapshot of Health in Canada as Demonstrated by Top 10 Lists, 2011, p. 10, accessed at: https://secure.cihi.ca/free_products/Top10ReportEN-Web.pdf.
^11	Cook C. et al., The Annual Global Economic Burden of Heart Failure, Int J Cardiol (2014), Table 5.
^12	McMurray JJ, Packer M, Desai AS, et al. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail 2013;15,1062–1073 (doi:10.1093/eurjhf/hft052).
^13	Langenickel TH, Dole WP. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discovery Today: Therapeutic Strategies. 2012, Vol 9. No.4.
^14	Solomon SD et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet. 2012; 380:1387–95.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Patricia Tiramani, Novartis Pharma Communications, [phone], E-mail: [email protected]; Spectrum Advisors: [phone], [email protected]