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In Heart Failure Patients Treated With ACE Inhibitor and/or Beta Blocker, Higher Plasma Renin Activity is Related to Greater Risk of Mortality

Basel, Switzerland (ots/PRNewswire)

  • New Analysis of Data From landmark 'Valsartan Heart Failure Trial' Adds to Growing Evidence That Plasma Renin Activity (PRA) is Linked to Cardiovascular Outcomes (1-3)
  • PRA is a Measure of the Activity of the Renin Angiotensin System (RAS)
  • The Only High Blood Pressure Treatment That Blocks the RAS and Lowers PRA by Directly Inhibiting the Activity of Renin is Rasilez(R) (aliskiren)(4,5)
  • Potential Long-term Benefits of Rasilez are Being Further Investigated as Part of ASPIRE HIGHER - the Largest Ongoing Cardio-renal Outcomes Program
Data confirm that in heart failure patients being treated with
ACE inhibitor and/or beta blocker, higher plasma renin activity still
predicts greater risk of mortality(1). PRA is a measure of the
activity of the renin angiotensin system (RAS) which, when
chronically activated, can lead to increased blood pressure and organ
damage.
A new analysis of data from the Val-HeFT (Valsartan Heart Failure
Trial) study in 4,291 chronic heart failure patients was presented at
the European Society of Cardiology (ESC) Congress in Barcelona. 93%
of the patients were on ACE inhibitor while beta blockers were
prescribed to 36% of the patients. Patients were stratified according
to levels of PRA at study entry and the association of baseline PRA
and all cause mortality at the end of the follow-up period was
assessed(1).
"This new Val-HeFT analysis shows that although ACE inhibitors
and beta blockers improve outcomes in patients with chronic heart
failure, there is still a strong relationship between higher levels
of PRA and mortality," said Professor Aldo Maggioni of the Italian
Association of Hospital Cardiologists Research Center, Florence,
Italy.
This latest evidence is in line with previous research linking
PRA to increased cardiovascular morbidity and mortality in heart
failure patients(2). Investigators from a recently published study of
699 optimally treated patients with heart failure conclude that PRA
predicts the occurrence of cardiovascular events(2).
Rasilez(R) (aliskiren) is a direct renin inhibitor (DRI) which
inhibits the activity of the enzyme renin resulting in a decrease of
PRA, angiotensin I and II(4,5). For the first time there is now a
potent RAS blocker available that reduces PRA alone and in
combination with other antihypertensives(6).
"Due to its unique mechanism of action of targeting the RAS at
the point of activation, Rasilez lowers PRA when used alone or in
combination with other high blood pressure medicines," said Trevor
Mundel, MD, Global Head of Development at Novartis Pharma AG. "The
PRA findings from the Val-HeFT study will be further examined in our
landmark ASPIRE HIGHER program where we are studying the potential of
Rasilez to protect the heart and kidney beyond current treatments."
An estimated 20 million people worldwide suffer from heart
failure and despite available treatments, the incidence of death from
heart failure continues to increase(7). Heart failure develops
slowly, often over years, as the heart gradually loses its pumping
ability, working less efficiently and eventually leading to death.
About Rasilez/Tekturna
Rasilez/Tekturna, a direct renin inhibitor, is the only drug that
works by directly targeting renin to decrease the activity of the
RAS4,5. Renin is an enzyme produced by the kidneys that starts a
process that narrows blood vessels and when inappropriately
activated, may lead to high blood pressure. By inhibiting renin,
Rasilez helps blood vessels relax and widen so blood pressure is
lowered.
The heart and kidney protection potential of Rasilez, in addition
to its blood pressure lowering ability, is currently being
investigated further in the landmark ASPIRE HIGHER program, the
largest ongoing cardio-renal outcomes program worldwide involving
more than 35,000 patients in 14 trials.
Rasilez/Tekturna is approved in over 70 countries. Tekturna was
approved in the US in March 2007 and in the European Union in August
2007 under the trade name Rasilez. In July 2009, Rasilez also
received approval in Japan. Tekturna HCT, the first single-pill
combination involving Tekturna, was approved in the US in January
2008 for second-line treatment of high blood pressure, and more
recently for first-line use. The single-pill combination Rasilez HCT
was approved in the European Union in January 2009. Other single-pill
combinations with Rasilez are currently in development including a
combination with Diovan(R) and a single-pill combination with
amlodipine.
About Val-HeFT
Val-HeFT (Valsartan Heart Failure Trial) is one of the largest
studies ever conducted in heart failure, involving 5,010 heart
failure patients. The study has previously demonstrated that Diovan
(valsartan) significantly reduced the combined endpoint of morbidity
and mortality by 13.2% (p=0.009) and hospitalization for heart
failure by 27.5% (p<0.001) in patients already receiving prescribed
therapy(8).
Val-HeFT also showed that Diovan significantly improved ejection
fraction (p=0.001), NYHA functional class (p<0.001) and clinical
signs and symptoms of heart failure8. In heart failure patients not
taking ACE inhibitors, Diovan significantly reduced heart failure
mortality by 33%, morbidity by 44% and hospitalizations by 56.4%(9).
Novartis is focused on improving the lives of the hundreds of
thousands of people with cardiovascular and metabolic diseases. As a
global leader in cardiovascular and metabolic health for nearly 50
years, Novartis provides innovative therapies and support programs to
treat high blood pressure and diabetes - both major public health
issues. The portfolio includes the number one selling blood pressure
medication worldwide, the first and only approved direct renin
inhibitor, a single pill combining two leading high blood pressure
medicines, and a DPP-4 inhibitor.
Disclaimer
The foregoing release contains forward-looking statements that
can be identified by terminology such as "potential," "predicts,"
"can," or similar expressions, or by express or implied discussions
regarding potential new indications or labelling for Rasilez/Tekturna
or regarding potential future revenues from Rasilez/Tekturna. You
should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Rasilez/Tekturna to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Rasilez/Tekturna will be approved for
any additional indications or labelling in any market. Nor can there
be any guarantee that Rasilez/Tekturna will achieve any particular
levels of revenue in the future. In particular, management's
expectations regarding Rasilez/Tekturna could be affected by, among
other things, unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing
clinical data; competition in general; government, industry and
general public pricing pressures; unexpected regulatory actions or
delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as
recorded in the Group's consolidated balance sheet, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. 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 healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
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http://www.novartis.com.
References
1 Masson S et al. Plasma renin activity retains a strong
prognostic value in patients with chronic HF, independent of ACE
inhibitor or beta-blocker therapy. Data from the Valsartan Heart
Failure Trial (Val-HeFT). Presented at the European Society of
Cardiology (ESC) Congress 2009.
2 Vergaro G, Fontana M, Poletti R, et al. Plasma renin activity
is an independent prognostic factor in chronic heart failure. Eur
Heart J 2008;29(Suppl):393(Abstract 2493).
3 Bair TL, May HT, Prescott MF, et al. Association between
baseline levels of plasma renin activity and risk of cardiovascular
events. Presented at the American College of Cardiology scientific
sessions, 29-31 March 2009, Orlando, FL, USA.
4 Müller DN, Luft FC. Direct renin inhibition with aliskiren in
hypertension and target organ damage. Clin J Am Soc Nephrol
2006;1:221-228.
5 Azizi M, Webb R, Nussberger J, Hollenberg NK. Renin inhibition
with aliskiren: where are we now, and where are we going? J Hypertens
2006;24:243-256.
6 Taylor AA, Anderson DR, Arora V, et al. Renin system
suppression with the oral direct renin inhibitor aliskiren
administered alone or in combination: a pooled analysis of 1093
patients with hypertension. J Am Coll Cardiol 2007;49(9 Suppl.
A):370A P-1014-1170.
7 Parsi A. Anaemia in heart failure: its diagnosis and
management. The European Journal of Heart Failure 2003;5:3-4.
8 Cohn JN et al. A randomized trial of the angiotensin-receptor
blocker valsartan in chronic heart failure. New England Journal of
Medicine 2001;345(23):1667-1675.
9 Maggioni, AP et al. Effects of valsartan on morbidity and
mortality in patients with heart failure not receiving
angiotensin-converting enzyme inhibitors. Journal of the American
College of Cardiology 2002;40(8 ):1414-1421.

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