New analysis of Novartis' Entresto® data shows long-term benefits on heart failure readmissions and total cardiovascular deaths
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Novartis International AG /
New analysis of Novartis' Entresto® data shows long-term benefits on heart
failure readmissions and total cardiovascular deaths
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* Entresto reduced the risk of first and subsequent events of heart failure
hospitalizations and cardiovascular deaths following heart failure
hospitalization by 20%-24% compared to enalapril[1]
* These findings are consistent with the benefit Entresto showed in reducing
the risk of a first event, which was the primary endpoint of the PARADIGM-HF
trial[2]
* Additional new analyses show that compared to enalapril, Entresto was
associated with more diuretic dose reductions, lowered risk of severe
hyperkalemia in patients taking an MRA, and reduced risk among HFrEF
patients with the most severe symptoms[3],[4],[5]
Basel, November 15, 2016 - Novartis announced today 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.
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 (natriuretic
peptide system) while simultaneously inhibiting the harmful effects of the
overactive renin-angiotensin-aldosterone system (RAAS).[13],[14] Other heart
failure medicines only block the harmful effects of the overactive
RAAS.[15] Entresto contains the neprilysin inhibitor sacubitril and the
angiotensin receptor blocker (ARB) valsartan.[13]
In Europe, Entresto is indicated in adult patients for the 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.[13] 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 "can," "continue to analyze," "confident," "growing," "to
date," "planned," "designed," 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
approximately 180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[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.
http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFa
ilure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp (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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Source: Novartis International AG via GlobeNewswire
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Datum: 15.11.2016 - 19:00 Uhr
Sprache: Deutsch
News-ID 507247
Anzahl Zeichen: 15739
contact information:
Town:
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Kategorie:
Business News
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