New analysis shows Novartis Entresto improves glycemic control in reduced ejection fraction heart failure patients with diabetes
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Novartis International AG /
New analysis shows Novartis Entresto improves glycemic control in reduced
ejection fraction heart failure patients with diabetes
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* New post-hoc analysis of PARADIGM-HF data demonstrates Entresto lowered
levels of HbA1c (a measure of glycemic control) by 0.26% vs. 0.16% for ACE-
inhibitor enalapril in heart failure with reduced ejection fraction (HFrEF)
patients who also had diabetes
* New use of insulin was also reduced by 29% among patients taking Entresto
compared to enalapril-treated patients[1]
* Up to 40% of HFrEF patients have diabetes, which is associated with worse
cardiovascular outcomes[2]
* New analysis presented today at the American College of Cardiology (ACC)
Annual Scientific Session and published in The Lancet Diabetes &
Endocrinology
Basel, March 18, 2017 - Novartis announced today results of a new post-hoc
analysis in a subgroup of patients with reduced ejection fraction heart failure
(HFrEF) and diabetes suggesting that Entresto(®) (sacubitril/valsartan) tablets
improved glycemic control, as assessed by hemoglobin A1c (HbA1c) testing,
compared to ACE-inhibitor enalapril[1]. HFrEF is also known as systolic heart
failure (HF)[3]. Entresto is indicated to reduce the risk of cardiovascular (CV)
death and hospitalization for HF in patients with chronic HF (NYHA Class II-IV)
and reduced ejection fraction[4]. It is not indicated to treat diabetes.
Entresto lowered HbA1c levels - a measure of average blood glucose levels for
the past two to three months - after one year of treatment for HF, and this
effect was sustained over three years of study follow-up[1]. In the analysis,
new use of insulin therapy or oral diabetes agents was also reduced in the
Entresto group[1]. The findings are based on data from PARADIGM-HF, the largest
clinical trial ever conducted in HF[5], and are simultaneously being presented
today at the American College of Cardiology (ACC) 66(th) Annual Scientific
Session & Expo in Washington, D.C. and published in The Lancet Diabetes &
Endocrinology.
"Diabetes is a major risk factor in heart failure and is strongly linked to
progression of the disease, putting heart failure patients at increased risk of
hospitalization and death," said Scott Solomon, MD, Director of Noninvasive
Cardiology, Brigham and Women's Hospital, Professor of Medicine, Harvard Medical
School, and senior author of the publication. "This analysis suggests that, in
addition to the proven heart failure benefits demonstrated in PARADIGM-HF,
Entresto may also help tighten glycemic control among heart failure patients
with diabetes."
An analysis was conducted of 3,778 HFrEF patients in the PARADIGM-HF trial who
were diagnosed with diabetes or had a baseline HbA1c >=6.5% without a reported
diagnosis at screening (98% of patients assessed had type 2 diabetes). The
investigators compared the effects of Entresto vs. enalapril on glycemic control
by measuring patients' HbA1c levels at screening and at one-, two-, and three-
year follow-up visits, and by evaluating patients' initiation of oral
antihyperglycemic or insulin therapy during the study.
This post-hoc analysis found that Entresto decreased HbA1c levels by 0.26%
during the first year of follow-up, compared to a 0.16% reduction with enalapril
(p=0.0023)[1]. Over three years, HbA1c levels remained persistently lower in
patients treated with Entresto compared to enalapril, with an overall reduction
of 0.14% (95% CI [0.06, 0.23]; p=0.0055)[1]. In addition, 29% fewer Entresto-
treated patients initiated insulin therapy to achieve glycemic control (114 (7%)
vs. 153 (10%) patients, HR 0.71, 95% CI, 0.56-0.90; p=0.0052)[1]. Entresto was
shown to reduce the risk of CV death or HF hospitalization compared with
enalapril among patients with or without diabetes at baseline[1],[6],[7].
"These results show that in addition to its compelling cardiovascular efficacy,
Entresto may have important metabolic benefits for HFrEF patients with
diabetes," said Vasant Narasimhan, Global Head, Drug Development and Chief
Medical Officer, Novartis. "We are excited about these results and committed to
improving our understanding of the benefits of Entresto in different heart
failure patient populations."
About Heart Failure
Heart failure (HF) is a debilitating and life-threatening condition, which
impacts more than 60 million people worldwide[8]. It is the leading cause of
hospitalization in people over the age of 65[9],[10]. About half of people with
HF have heart failure with reduced ejection fraction (HFrEF)[11]. Reduced
ejection fraction means the heart does not contract with enough force, so less
blood is pumped out[12]. HF 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[9],[13].
Novartis has established the largest global clinical program in the HF disease
area across the pharma industry to date, FortiHFy, comprising more than 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)[4],[14]. Other HF
medicines only block the harmful effects of the overactive RAAS[3]. Entresto
contains the neprilysin inhibitor sacubitril and the angiotensin receptor
blocker (ARB) valsartan[4].
In Europe, Entresto is indicated in adult patients for the treatment of
symptomatic chronic heart failure with reduced ejection fraction (HFrEF). In the
United States, Entresto is indicated to reduce the risk of cardiovascular (CV)
death and hospitalization for HF in patients with chronic HF (NYHA class II-IV)
and reduced ejection fraction[14]. Entresto is usually administered in
conjunction with other HF therapies, in place of an ACE inhibitor or other
angiotensin receptor blocker (ARB). Approved indications may vary depending upon
the individual country.
About PARADIGM-HF
PARADIGM-HF was a randomized, double-blind, Phase III study evaluating the
efficacy and safety profile of Entresto versus enalapril (a widely studied ACE
inhibitor) in 8,442 patients with HFrEF[15],[16]. The baseline characteristics
showed the patients enrolled were typical HFrEF patients with NYHA Class II-IV
heart failure. PARADIGM-HF was specifically designed to see if Entresto could
decrease CV mortality by at least 15% vs. enalapril. Patients received Entresto
or enalapril in addition to current best treatment regimen[15]. The primary
endpoint was a composite of time to first occurrence of either CV death or HF
hospitalization, and is the largest HF study ever done[15].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "suggests," "may," "suggesting," "excited," "committed,"
"growing," 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 clinical trial results and
additional analysis of existing clinical data; 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; 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,
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.
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References
[1] Seferovic J, Claggett B, Seidelmann S, et al. Influence of
Sacubitril/Valsartan on Glycemic Control in Patients with Heart Failure and
Diabetes Mellitus: The PARADIGM-HF Trial. The Lancet Diabetes & Endocrinology.
[2] Mentz RJ, Kelly JP, von Lueder TG, et al. Noncardiac comorbidities in heart
failure with reduced versus preserved ejection fraction. J Am Coll Cardiol.
2014; 64(21):2281-2293.
[3] 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.
[4] Entresto Prescribing Information.
[5] 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.
[6] McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition
versus enalapril in heart failure. N Engl J Med. 2014; 371:993-1004.
[7] Kristensen SL, Preiss D, Jhund PS, et al. PARADIGM-HF Investigators and
Committees. Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart
Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of
ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart
Failure Trial. Circ Heart Fail. 2016; 9(1).
[8] 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; 386(9995):743-800.
[9] 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.
[10] 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.
[11] 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.
[12] Ejection Fraction Heart Failure Measurement. American Heart Association
Website. Available at:
http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFa
ilure/Ejection-Fraction-Heart-Failure-
Measurement_UCM_306339_Article.jsp. Published March 24, 2015. Last accessed
March 2017.
[13] 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.
[14] Langenickel T, Dole W. Angiotensin receptor-neprilysin inhibition with
LCZ696: a novel approach for the treatment of heart failure. Drug Discovery
Today. 2012; 4:131-139.
[15] 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.
[16] Clincaltrials.gov, NCT01035255. Link is external. Last accessed online
March 2017.
# # #
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Source: Novartis International AG via GlobeNewswire
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Datum: 18.03.2017 - 14:45 Uhr
Sprache: Deutsch
News-ID 531029
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contact information:
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