Novartis International AG / New analysis shows Novartis Entresto
improves glycemic control in reduced ejection fraction heart failure
patients with diabetes . Processed and transmitted by Nasdaq Corporate
Solutions. The issuer is solely responsible for the content of this
announcement.
-- 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(R)
(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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