Exforge® helps nearly twice as many patients control their high blood
pressure compared to amlodipine alone
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* New data show that patients on Exforge with baseline blood
pressure >=180 mmHg experienced significant reductions of up to
40 mmHg to help reach target levels[1]
* Significant blood pressure reductions seen with Exforge across
difficult-to-treat groups such as the elderly, obese and people
with diabetes[1]
* High blood pressure is a leading but treatable risk factor for
cardiovascular disease - the world's leading cause of death[2]
* New data show that patients on Exforge with baseline blood
pressure >=180 mmHg experienced significant reductions of up to
40 mmHg to help reach target levels[1]
* Significant blood pressure reductions seen with Exforge across
difficult-to-treat groups such as the elderly, obese and people
with diabetes[1]
* High blood pressure is a leading but treatable risk factor for
cardiovascular disease - the world's leading cause of death[2]
Basel, July 28, 2008 - New data show that Exforge, a single-pill
combination of the world's leading high blood pressure medicines
Diovan® (valsartan) and amlodipine, gets nearly twice as many
patients with high baseline blood pressure to a healthier blood
pressure goal compared to amlodipine alone[1].
Results of a study in patients with systolic baseline blood pressure
>=160 mmHg, published in The Journal of the American Society of
Hypertension, showed that 51.8% of patients on Exforge achieved
systolic blood pressure control defined as <140 mmHg at week four,
compared to 27.7% of those on amlodipine alone1. Systolic blood
pressure, measured when the heart contracts and pumps, is an
important indicator of a person's risk of cardiovascular events[3].
"The blood pressure drops achieved with Exforge are important since
systolic blood pressure continues to increase with age. Therefore as
population demographics shift towards older age, the cardiovascular
disease burden could almost be entirely attributable to systolic
blood pressure," said Dr. Maurizio Destro, lead investigator from the
Azienda Ospedaliera di Pavia in Italy. "Furthermore, 65% of people
with high blood pressure do not achieve their blood pressure goal,
and most require two or more medicines. Patients are more likely to
keep taking a single pill a day rather than multiple medications, so
Exforge is clearly an important and effective therapy option."
The primary endpoint of the study was the change from baseline Mean
Sitting Systolic Blood Pressure (MSSBP) at week four. Results showed
that on average, patients on Exforge experienced a significant 30.1
mmHg reduction in systolic blood pressure compared to a 23.5 mmHg
reduction in patients on amlodipine alone[1].
In the same study, patients with systolic blood pressure >=180 mmHg
treated with Exforge experienced significant systolic blood pressure
reduction of up to 40.1 mmHg, compared with 31.7 mmHg for those
treated with amlodipine alone[1].
Exforge also demonstrated significantly better blood
pressure-lowering efficacy than amlodipine alone across certain
difficult-to-treat patient groups, including the elderly (over 65
years), obese people and those with diabetes[1].
Treatment guidelines recommend that patients with high blood pressure
>=160/100 mmHg should be considered for a combination of two
medicines from different drug classes[4].
"To lower the risk of complications from uncontrolled high blood
pressure, it is vital to treat patients early and effectively," said
Trevor Mundel, MD, Head of Global Development Functions at Novartis
Pharma AG. "Exforge consistently demonstrates large blood pressure
drops across all stages of high blood pressure and has been shown to
get as many as nine out of 10 patients without diabetes to goal."
High blood pressure is a leading cause of cardiovascular disease, the
world's number one cause of death[2]. Controlling high blood pressure
can reduce complications such as heart attack, heart failure, stroke,
kidney failure and premature death[3].
The study was designed to investigate and compare the efficacy and
safety of Exforge with amlodipine in patients with stage 2 high blood
pressure (a more severe stage of the disease, with systolic blood
pressure between 160 and 200 mmHg). It was a randomized,
double-blind, multi-center parallel-group study carried out in 75
centers across Europe and the US. In total, 646 patients were
randomized to receive treatment with Exforge 5-10/160 mg (n=322) or
amlodipine 5-10 mg (n=324). Demographic and high blood pressure
baseline characteristics were similar for both groups[1].
Overall blood pressure measurements consist of two values, both
expressed in millimeters of mercury (mmHg). The first is the systolic
blood pressure when the heart beats and the second is the diastolic
pressure when the heart relaxes between beats. In this study, overall
blood pressure control rates (<140/90 mmHg) were higher at all
assessment points for patients treated with Exforge than for those
receiving amlodipine alone. In this study both medications were well
tolerated[1].
Novartis is focused on improving the lives of the hundreds of
millions 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 core of the Novartis portfolio is its cardiovascular medications
for the treatment of high blood pressure and diabetes. These include
the world's most-prescribed angiotensin receptor blocker, the first
and only approved direct renin inhibitor, a single pill combining two
leading high blood pressure medicines, and a novel DPP-4 inhibitor.
Novartis is dedicated to helping physicians and patients improve
cardiovascular and metabolic health through effective medicines,
programs and an ongoing commitment to research.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "may," "potential,"
"could," or similar expressions, or by express or implied discussions
regarding potential new indications or labelling for Exforge or
regarding potential future revenues from Exforge. Such
forward-looking statements reflect the current views of the Company
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Exforge to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that Exforge will be approved for any
additional indications or labelling in any market. Nor can there be
any guarantee that Exforge will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding Exforge could be affected by, among other things,
unexpected regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing
clinical data; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures,
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 AG 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 2007, the
Group's continuing operations (excluding divestments in 2007)
achieved net sales of USD 38.1 billion and net income of USD 6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 98,000 full-time associates and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] Destro et al. Efficacy and Safety of Amlodipine/Valsartan
Compared with Amlodipine Monotherapy in Patients with Stage 2
Hypertension: A Randomized, Double-blind, Multicenter Study: The
EX-EFFeCTS Study. The Journal of the American Society of
Hypertension. On-line publication doi:10.1016/j.jash.2008.01.004
[2] Kearney et al. Global burden of hypertension: analysis of
worldwide data. The Lancet. 2005;265:217-23
[3] Chobanian et al. Seventh Report of the Joint National Committee
on prevention, detection, evaluation, and treatment of high blood
pressure. Hypertension. 2003;42:12006-1251.
[4] Mancia G et al. The 2007 ESH/ESC Guidelines for the management
of arterial hypertension. J Hypertens 2007;26(4):825-6.
# # #
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Novartis International AG
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