Timely use of Novartis' Entresto could prevent or postpone over 28,000 US deaths per year among HFrEF patients, according to an expert analysis in JAMA Cardiology
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Novartis International AG /
Timely use of Novartis' Entresto could prevent or postpone over 28,000 US deaths
per year among HFrEF patients, according to an expert analysis in JAMA
Cardiology
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* Findings are first to quantify magnitude of potential survival benefits if
Entresto were prescribed to all eligible US HFrEF patients (as defined by
authors) [1]
* Cardiology experts highlight risk of delaying broad adoption of Entresto in
patients with HFrEF and call for efforts to accelerate treatment uptake [1]
* Report reinforces independently released HF Treatment Guideline update by
leading US cardiology societies that gave Entresto a strong Class 1
recommendation for the management of HFrEF [1,2]
* Separate analysis in JAMA Cardiology shows Entresto to be cost effective
compared to ACE inhibitor treatment, and consistent with other high-value
cardiovascular interventions [3]
Basel, June 22, 2016 - A new analysis published today in JAMA Cardiology has
found that timely and broad adoption of Entresto® (sacubitril/valsartan) by all
eligible heart failure patients with reduced ejection fraction (HFrEF) could
prevent or postpone more than 28,000 deaths each year in the US alone. [1] This
analysis, based on an application of the results of PARADIGM-HF to published
heart failure statistics, is the first to quantify the possible impact of
Entresto's potential benefit in reducing death. [1]
Heart failure is a chronic condition that contributes to more than 300,000
deaths in the US every year. [4] About half of people with heart failure have
HFrEF. [5] This new analysis estimates that as many as 28,484 deaths in HFrEF
patients annually could be prevented or postponed with optimal use of Entresto
(with sensitivity analyses demonstrating a range of 18,230 to 41,017)(.) [1]
Further, the study suggests that delaying routine use of Entresto in clinical
practice could have a substantial negative effect on patients, given the
expected risk-benefit profile, as it could result in failure to prevent tens of
thousands of deaths. [1] These findings demonstrate the significant survival
benefits Entresto could offer to those living with HFrEF, if patients in the
group defined by the authors were given access to treatment. [1] The study
authors stated that nearly 84% of HFrEF patients - 2.2 million people - may be
candidates for treatment with Entresto. [1]
Heart failure is a life-threatening condition and despite available medicines,
about half of patients diagnosed with heart failure die within 5 years. [4,6,7]
According to the study authors, these findings may substantially impact the
national health of the HFrEF population, offering significant clinical benefit
in preventing or postponing death when applied in clinical practice. [1]
"This analysis demonstrates that Entresto can save the lives of thousands of
patients every year if used in all eligible heart failure patients with reduced
ejection fraction (HFrEF)," said Vas Narasimhan, Global Head of Development and
Chief Medical Officer for Novartis. "Entresto has now independently received a
class I recommendation in clinical guidelines and was shown in multiple analysis
to be cost effective so physicians and health care systems should feel confident
in ensuring rapid and broad use of this breakthrough medicine."
In a separate analysis published in the same issue of JAMA Cardiology,
researchers used data from the PARADIGM-HF trial to model the health
consequences and cost-effectiveness of Entresto over a 30-year time period. [3]
They compared Entresto to the ACE-inhibitor enalapril and found Entresto was
associated with more than a year longer average survival time, and that it was
cost-effective compared to enalapril when these medications were used with other
standard of care therapies. [3] For every 1,000 patients treated with Entresto
vs. enalapril, potentially 59.7 HF hospital admissions could be averted per each
year alive in the model. [3] In addition, Entresto increased life expectancy at
an incremental cost-effectiveness ratio consistent with other high-value widely
accepted cardiovascular interventions such as implantable cardioverter
defibrillators (ICDs) and cholesterol-lowering statins before they became
generic. [3]
About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts
over 60 million people worldwide [6]. It is the leading cause of hospitalization
in people over the age of 65 [4,8]. About half of people with heart failure have
HFrEF [5]. Reduced ejection fraction means the heart does not contract with
enough force, so less blood is pumped out [8]. Heart failure presents a major
and growing health-economic burden that currently costs the world economy $108
billion every year [4,10], which accounts for both direct and indirect costs.
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.
About Entresto
Entresto is a twice-a-day medicine that reduces the strain on the failing heart.
It does this by enhancing the protective neurohormonal systems of the heart (NP
system) while simultaneously suppressing the harmful effects of the overactive
renin-angiotensin-aldosterone system (RAAS) [11]. Other heart failure medicines
only block the harmful effects of the overactive RAAS. [12] Entresto contains
the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB)
valsartan [11].
In Europe, Entresto is indicated in adult patients for treatment of symptomatic
chronic heart failure with reduced ejection fraction. In the U.S. Entresto is
indicated for the treatment of heart failure (NYHA class II-IV) in patients with
systolic dysfunction [11]. It has been shown to reduce the rate of
cardiovascular death and heart failure hospitalization compared to enalapril,
and also to reduce the rate of all-cause mortality compared to enalapril.
Entresto is usually administered in conjunction with other heart failure
therapies, in place of an ACE inhibitor or other angiotensin receptor blocker
(ARB). Approved indications may vary depending upon the individual country.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "could," "potential," "call for," "accelerate," "possible,"
"suggests," "expected," "may," "can," or similar terms, or by express or implied
discussions regarding potential new indications or labeling for Entresto, or
regarding potential future revenues from Entresto. You should not place undue
reliance on these statements. Such forward-looking statements are based on the
current beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that Entresto
will be submitted or approved for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that Entresto
will be commercially successful in the future. In particular, management's
expectations regarding Entresto could be affected by, among other things, the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally; the
company's ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
safety, quality or manufacturing issues, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
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,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Fonarow GC, Hernandez AF, Solomon SD, et al. Potential Mortality Reduction
with Optimal Implementation of Angiotensin Receptor Neprilysin Inhibitor Therapy
in Heart Failure. JAMA Cardiol. 2016;1(6):1-4. doi:10.1001/jamacardio.2016.1724
[2] Yancy CW, Jessup M, Bozkurt B, Butler J, Casey Jr DE, Colvin MM, Drazner,
MH, Filippatos G, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi
FA, McBride, PE, Peterson PN, Stevenson LW, Westlake C, 2016 ACC/AHA/HFSA
Focused Update on New Pharmacological Therapy for Heart Failure: An Update of
the 2013 ACCF/AHA Guideline for the Management of Heart Failure, Journal of the
American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.05.011.
[3] Gaziano TA, Fonarow GC, et al. Cost-Effectiveness Analysis of
Sacubitril/Valsartan versus Enalapril in Heart Failure Patients with Reduced
Ejection Fraction in the United States. JAMA Cardiol. 2016;
http://cardiology.jamanetwork.com/journal.aspx
[4] 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
[5] 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
[6] Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence
and survival community-based population. JAMA. 2004;292:344-350
[7] Levy D, Kenchaiah S, Larson MG, et al. Long term trends in the incidence and
survival with heart failure. N Engl J Med. 2002;347(18):1397-1422.
[8] 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.
[9] Ejection Fraction Heart Failure Measurement. American Heart Association
Website.http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosiso
fHeartFailure/Ejection-Fraction-Heart-Failure-
Measurement_UCM_306339_Article.jsp. Published March 24, 2015. Accessed March
10, 2016.
[10] 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.
[11] Entresto Prescribing Information
[12] 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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Datum: 22.06.2016 - 17:30 Uhr
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