New analyses show Novartis' Entresto(TM) reduced cardiovascular death or hospitalization for heart failure, consistently benefitting patients with reduced ejection fraction regardless...
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Novartis International AG /
New analyses show Novartis' Entresto(TM) reduced cardiovascular death or
hospitalization for heart failure, consistently benefitting patients with
reduced ejection fraction regardless...
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New analyses show Novartis' Entresto((TM)) reduced cardiovascular death or
hospitalization for heart failure, consistently benefitting patients with
reduced ejection fraction regardless of prior heart failure hospital admissions
or background therapy
* The analysis determined that Entresto benefited patients considered
clinically stable, with no history or only a remote history of prior heart
failure hospitalization, just as much as it did those who were least-stable
(heart failure hospitalization within 3 months of baseline).[1]
* For just over half of patients considered clinically stable who experienced
an event, the first event was cardiovascular death[1]
* In a second analysis, patients taking Entresto had about a 20% reduction in
CV death or heart failure hospitalization compared to those taking
enalapril, regardless of background therapy[1],[2]
The digital press release with multimedia content can be accessed here:
Basel, April 2, 2016 - Novartis announced today new analyses of the data from
PARADIGM-HF showing that Entresto((TM)) (sacubitril/valsartan) consistently
demonstrated benefit among heart failure patients with reduced ejection fraction
(HFrEF), even when patients are considered clinically stable and regardless of
background therapy.[1],[2]
An analysis of PARADIGM-HF patients found the following:
* Even patients considered clinically stable - defined as patients with no
history or a remote history of prior heart failure hospitalization - were
still at risk for a serious clinical event.
* In the analysis, over one third of patients were identified as clinically
stable, and 20% of those experienced a primary endpoint event (CV death or
heart failure hospitalization).[1] Among these patients, 51% suffered CV
death as their first event.
* Further, the analysis determined that Entresto benefited patients considered
clinically stable just as much as it did those who were least-stable (heart
failure hospitalization within 3 months of baseline).[1]
* Among both groups, patients taking Entresto had a 20% or greater reduction
in CV death or heart failure hospitalization compared to those taking
enalapril.[1]
"This new analysis shows that heart failure patients are never truly stable
since in the majority of patients their first clinical event was death. We
cannot afford to wait for patients to worsen to use Entresto and improve their
chance at a better length of life," said Vas Narasimhan, Global Head, Drug
Development and Chief Medical Officer. "These data also show treating with
Entresto led to a 20% or greater reduction in cardiovascular death or heart
failure hospitalization in patients with reduced ejection fracture (HFrEF)
including those who are considered clinically stable and regardless of
background therapy."
In another analysis of PARADIGM-HF, Entresto showed:
* Consistent benefits among HFrEF patients, reducing the risk of CV death or
heart failure hospitalization by approximately 20% compared to enalapril,
regardless of background therapy.[2]
* These benefits were observed for Entresto among patients taking higher and
lower doses of beta blockers and those with or without an implantable
cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy
defibrillator (CRT-D) - two commonly used treatment approaches for heart
failure - as well as mineralocorticoid receptor antagonists (MRAs).[2]
The analyses are from PARADIGM-HF, the largest clinical trial ever conducted in
heart failure comparing Entresto to current standard of care, [3] and are being
presented at the American College of Cardiology's 65th Annual Scientific Session
in Chicago.
About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts
nearly 6 million Americans and is the leading cause of hospitalization among
Americans over the age of 65. [4],[5] About half of people with heart failure
have heart failure with reduced ejection fraction (HFrEF).[6] Reduced ejection
fraction means the heart does not contract with enough force, so less blood is
pumped out.[7] Heart failure presents a major and growing health-economic burden
that currently exceeds $30 billion in the United States, which accounts for both
direct and indirect costs.[4],[8]
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).[9] Other heart failure medicines
only block the harmful effects of the overactive RAAS.[10] Entresto contains the
neprilysin inhibitor sacubitril, which is a new molecular entity, and the
angiotensin receptor blocker (ARB) valsartan.[9]
Entresto is approved for patients with chronic heart failure with reduced
ejection fraction (HFrEF) in more than 50 markets worldwide.
Entresto is indicated for the treatment of heart failure (NYHA class II-IV) in
patients with systolic dysfunction. Entresto has been shown to reduce the rate
of cardiovascular death and heart failure hospitalization compared to enalapril.
Entresto has also been shown to reduce the rate of all-cause mortality compared
to enalapril. Entresto is indicated in the US to reduce the risk of
cardiovascular death and hospitalization for heart failure in patients with
chronic heart failure (NYHA Class II-IV) and reduced ejection
fraction.[9] Entresto is usually administered in conjunction with other heart
failure therapies, in place of an ACE inhibitor or other angiotensin receptor
blocker (ARB).
Entresto is indicated in adult patients for treatment of symptomatic chronic
heart failure with reduced ejection fraction
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "being presented" 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 issues; unexpected manufacturing or quality 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 119,000
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.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Solomon S. Efficacy of Sacubitril/Valsartan Relative to a Prior
Decompensation in Patients with Heart Failure and Reduced Ejection Fraction: The
PARADIGM-HF Trial [manuscript]. American College of Cardiology's 65th Annual
Scientific Session & Expo; Chicago, IL, USA.
[2] McMurray JJV. Consistent Benefit Of Sacubitril/valsartan Over Enalapril,
Irrespective Of Background Therapy In Paradigm-hf [abstract]. American College
of Cardiology's 65th Annual Scientific Session & Expo; Chicago, IL, USA.
[3] 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.
[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; 132:000-000. doi: 10.1161/CIR.0000000000000350.
[5] Wier 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.
[6] 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.
[7] 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.
[8] 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.
[9] Entresto Prescribing Information.
[10] 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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[HUG#1999975]
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Datum: 02.04.2016 - 17:00 Uhr
Sprache: Deutsch
News-ID 461422
Anzahl Zeichen: 14053
contact information:
Town:
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Business News
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