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* Study sub-group with severe high blood pressure shows largest
blood pressure drop to date in an Exforge clinical trial[2,3,4]
* After only two weeks, Exforge delivered significantly greater
reductions in blood pressure than amlodipine alone[1]
* 20 mmHg decrease in systolic blood pressure halves risk of death
from heart disease or stroke[5]
* Study sub-group with severe high blood pressure shows largest
blood pressure drop to date in an Exforge clinical trial[2,3,4]
* After only two weeks, Exforge delivered significantly greater
reductions in blood pressure than amlodipine alone[1]
* 20 mmHg decrease in systolic blood pressure halves risk of death
from heart disease or stroke[5]
Basel, May 14, 2008 - New multinational data show that black patients
treated with Exforge® experienced a significantly higher reduction in
systolic blood pressure than those on amlodipine alone (33 mmHg vs.
27 mmHg, P<0.0001)[1].
In addition, a subgroup of black patients with severe high blood
pressure achieved an average systolic blood pressure reduction of 50
mmHg[1] when taking Exforge and, in some cases, additional
hydrochlorothiazide (HCT) at the discretion of the investigator. This
is the most significant blood pressure drop seen to date in an
Exforge clinical trial[2,3,4].
Exforge, a combination of the world's leading high blood pressure
medicines Diovan® (valsartan) and amlodipine, produced a significant
decrease in blood pressure after only two weeks compared to
amlodipine alone (25 mmHg vs. 19 mmHg, P<0.0001)[1].
Uncontrolled blood pressure in difficult-to-treat patients can lead
to an increased risk of heart attack and stroke[6]. Studies have
shown that lowering systolic blood pressure by 20 mmHg can halve the
risk of heart attack and stroke[5].
"The large blood pressure reductions seen in this trial were
experienced by severe patients who have the most difficulty getting
their blood pressure to healthy levels," said Dr. John M. Flack, the
lead investigator from Wayne State University School of Medicine,
Detroit. "These data may have a real impact on helping patients who
are most at risk."
The results, presented today at the American Society of Hypertension
(ASH) 23rd Annual Scientific Meeting and Exposition in New Orleans,
show that Exforge got patients in a difficult-to-treat group - black
patients with systolic blood pressure >=160 mmHg - to healthy blood
pressure levels[1].
Black patients are at higher risk of developing high blood pressure
than other ethnic groups for reasons that are not fully
understood[7]. They are also less likely than white patients to
achieve blood pressure control while receiving treatment[7].
Guidelines recommend that combination therapy should be used as
first-line treatment in difficult-to-treat patient groups[6,8].
Exforge is not currently approved as a first-line treatment for high
blood pressure.
High blood pressure is a leading risk factor for cardiovascular
disease - the world's number one cause of death[9]. The condition is
treatable, yet 70% of people with high blood pressure are not at
goal[10].
"With Exforge, we have a treatment that can help many patients
achieve healthy blood pressure levels," said Trevor Mundel, MD, Head
of Global Development Functions at Novartis Pharma AG. "Importantly,
Exforge has been shown to be effective across all grades of high
blood pressure and to get as many as nine out of 10 patients to goal.
In this study, Exforge demonstrated strong blood pressure lowering
efficacy in high-risk, more difficult-to-treat patient populations.
Exforge provides an important and effective treatment option for
physicians."
The study presented at ASH investigated whether combination therapy
with Exforge is an effective choice in difficult-to-treat, black
patients with stage 2 high blood pressure - a more severe stage of
the disease, with systolic blood pressure between 160 and
200 mmHg[1]. Systolic blood pressure, measured when the heart
contracts and pumps, is the most important indicator of a person's
risk of cardiovascular events[6].
The 12-week randomized, double-blind, parallel-group study was
carried out among black patients in the US, South America and South
Africa. A total of 572 black patients were randomized to receive
either Exforge 5-10/160 mg (n=286) or amlodipine 5-10 mg and placebo
(n=286). Demographic and baseline clinical characteristics were
comparable between groups[1].
The primary endpoint of the study was the change in systolic blood
pressure after eight weeks. Results showed that on average, patients
treated with Exforge experienced a significantly greater reduction in
systolic blood pressure than those on amlodipine alone (33 mmHg vs.
27 mmHg, P<0.0001)[1]. After eight weeks, those patients with a
systolic blood pressure >=130 mmHg could have open-label HCT added at
the investigator's discretion (Exforge n=146, amlodipine n=183)[11].
At study end, the sub-group of patients with systolic blood pressure
>=180 mmHg at baseline taking Exforge, and in some cases HCT at the
discretion of the investigator, achieved an average systolic blood
pressure reduction of 50 mmHg (n=35), compared to an average 41 mmHg
reduction in those taking amlodipine with additional HCT at the
discretion of the investigator (n=40, P=0.047)[1]. Both medications
were well tolerated with adverse events being mild, transient and
consistent with the class of agents studied[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 "risk", "can", "may", "likely",
"should", 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 clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data;
competition in general; unexpected regulatory actions or delays or
government regulation generally; the company's ability to obtain or
maintain patent or other proprietary intellectual property
protection; 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 growth areas in
healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and 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] Flack J et al. Efficacy and Safety of Amlodipine/Valsartan
Combination Therapy Compared with Amlodipine Monotherapy in Black
Patients with Stage 2 Hypertension. ASH, 2008.
[2] Poldermans D et al. Tolerability and Blood Pressure-Lowering
Efficacy of the Combination of Amlodipine Plus Valsartan Compared
with Lisinopril Plus Hydrochlorothiazide in Adult Patients with Stage
2 Hypertension. Clinical Therapeutics. 2007;29:1-11.
[3] Philipp T et al. Two Multicenter, 8-Week, Randomized,
Double-Blind, Placebo-Controlled, Parallel-Group Studies Evaluating
the Efficacy and Tolerability of Amlodipine and Valsartan in
Combination and as Monotherapy in Adult Patients with Mild to
Moderate Essential Hypertension. Clinical Therapeutics.
2007;29:563-580.
[4] Smith TR et al. Amlodipine and Valsartan Combined and as
Monotherapy in Stage 2, Elderly, and Black Hypertensive Patients:
Subgroup Analyses of 2 Randomized, Placebo-Controlled Studies.
Journal of Clinical Hypertension. 2007;9:355-364.
[5] Lewington et al. Age-specific relevance of usual blood pressure
to vascular mortality: a meta analysis on individual data for one
million adults in 61 prospective studies. The Lancet. 2001;360:1903.
[6] Chobanian AV et al. Seventh report of the Joint National
Committee on prevention, detection, evaluation and treatment of high
blood pressure. Hypertension. 2003;42:1206-1251
[7] Hertz et al. Racial Disparities in Hypertension Prevalence,
Awareness, and Management. Arch Intern Med. 2005;165:2098-2104.
[8] The Task Force for the Management of Arterial Hypertension of the
European Society of Hypertension (ESH) and of the European Society of
Cardiology (ESC). 2007 Guidelines for the Management of Arterial
Hypertension. Eur Heart J. 2007;28:1462-1536.
[9] Kearney et al. Global burden of hypertension: analysis of
worldwide data. The Lancet. 2005;365:217-23
[10] Ong et al. Prevalence, Awareness, Treatment, and Control of
Hypertension Among United States Adults 1999-2004. Hypertension.
2007;49:69-75.
[11] Flack J et al. Combination of Angiotensin-receptor blocker,
Calcium-channel blocker and Diuretic is Safe and Effective in the
Management of Severe Hypertension in Blacks. ASH, 2008.
# # #
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