Study halted early due to superior outcomes
DORVAL, QC, April 30 /CNW/ - New findings from the independent Jikei
Heart Study, published in this week's issue of The Lancet(1), show that adding
the blood pressure lowering medication (PR)Diovan(*) (valsartan) to conventional
therapy produced a dramatic 39% reduction in cardiovascular events, including
a 40% reduction in stroke. The superior benefits in the Diovan treatment group
led to an early termination of this study, which involved more than 3,000
The Jikei Heart Study is the first controlled trial to assess the
cardiovascular benefits of adding the angiotensin receptor blocker (ARB)
Diovan to conventional therapy, compared to conventional therapy alone in a
large Japanese population with high blood pressure, coronary heart disease
and/or heart failure. Key events evaluated as part of the primary endpoint
included heart attack, stroke and hospitalization for heart failure or angina
In addition to its impact on overall cardiovascular events and stroke,
Diovan demonstrated relative reductions of 65% in hospitalizations for angina
pectoris (recurring acute chest pain) and 46% in hospitalizations for heart
failure (a progressive disorder manifested by fluid congestion and weakening
of the heart) compared to the other treatment group(1). According to
investigators, these benefits cannot be explained by a difference in blood
pressure alone(1). There were few adverse events (2.5% overall) with no
significant difference in tolerability between treatment groups.
"The findings from the Jikei Heart Study are important for physicians who
are trying to prevent their patients from long-term cardiovascular
complications, such as stroke," said Peter Lin, MD, CCFP, Primary Care
Physician, Toronto, Ontario. "This study is relevant because it followed
patients with existing conditions common in clinical practice. The results
demonstrate that reducing blood pressure to target is important, but which
medication we choose is also critical. It also complements previous evidence
that adding Diovan to usual treatment for high blood pressure can also offer
More details on the trial
The Jikei Heart Study(1) was an investigator-initiated, multi-center,
controlled clinical trial with a prospective randomized, open-label, blinded
endpoint (PROBE) design. It was conducted by the Jikei University School of
Medicine in Tokyo in 3,081 Japanese people aged 20 to 79 years with high blood
pressure, ischemic heart disease or congestive heart failure. Patients were
randomly assigned to one of two treatment arms: treatment with the angiotensin
receptor blocker (ARB) Diovan or a non-ARB therapy (standard antihypertensive
therapy excluding other ARBs).
There were no significant differences in blood pressure or heart rate
between the treatment groups.
Key events counted in the primary composite endpoint of cardiovascular
mortality and morbidity (which measured an overall 39% reduction in events)
were: new or recurrent stroke or transient ischemic attack (a mini-stroke),
hospitalization for congestive heart failure, or angina pectoris, heart
attack, dissecting aortic aneurysm, lower limb arterial obstruction (blockages
in the arteries in the lower body), doubling of serum creatinine (a
measurement of kidney function), or transition to dialysis.
The study was conceived, designed, and conducted by an investigator-led
steering committee, representing the Jikei Executive Committee and the
hospitals involved with the trial. The study was funded by the Jikei
University School of Medicine in Tokyo with an unrestricted grant from
Novartis. Novartis had no role in study design, data collection, data
analysis, data interpretation or writing of the report.
The conventional therapies in both groups included medications such as
calcium channel blockers, ACE inhibitors, beta blockers, statin medications
Cardiovascular disease and stroke in Canada
Cardiovascular disease accounts for the death of more Canadians than any
other disease. In 2002 (the latest year for which Statistics Canada has data),
cardiovascular disease accounted for approximately 75,000 Canadian deaths: 54%
of all cardiovascular deaths are due to coronary artery disease; 21% to
stroke; 16% to other forms of heart disease such as problems with the
electrical system of the heart, viral heart infections, and heart muscle
disease, and the remaining 9% to vascular problems such as high blood pressure
and hardening of the arteries(2).
In Canada, stroke is the fourth most common cause of death. Between
40,000 to 50,000 Canadians suffer from a stroke each year, resulting in
approximately 16,000 deaths. Of these sufferers, more than 40% are left with a
moderate to severe impairment, while 10% are so severely disabled they require
Approved in Canada in 1997, Diovan (valsartan) is a highly selective
angiotensin II ATI receptor blocker (ARB), and is indicated in Canada for the
treatment of mild to moderate essential hypertension and to reduce
cardiovascular mortality in clinically stable patients with signs and symptoms
of left ventricular dysfunction in conjunction with acute myocardial
infarction when the use of an angiotensin-converting enzyme inhibitor (ACEI)
is not appropriate. Diovan may be administered alone, or in combination with
thiazide diuretics or as a fixed dose combination called Diovan-HCT.
Novartis is focused on improving the care of patients with high blood
pressure and heart disease through world-class research and unprecedented
public health initiatives. The Diovan clinical trial programme is one of the
world's largest in cardiovascular research, involving approximately 50,000
patients. Completed Diovan trials include Val-HeFT in heart failure patients,
VALUE in high risk patient populations, as well as VALIANT in patients
following heart attack. Ongoing studies include NAVIGATOR in pre-diabetes
patients at high risk for cardiovascular disease.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can offer" or similar expressions, or by
express or implied discussions regarding potential new indications or
labelling for Diovan or Diovan-HCT, or regarding potential future sales of
these products. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause actual results with
Diovan or Diovan-HCT to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Diovan or Diovan-HCT will be approved for any additional
indications or labelling in any other market. Nor can there be any guarantee
regarding potential future sales of Diovan or Diovan-HCT. In particular,
management's expectations regarding these products could be affected by, among
other things, competition in general; industry, government, and general public
pricing pressures; unexpected clinical trial results, including additional
analysis of existing clinical data, and new clinical data; unexpected
regulatory actions or delays or government regulation generally; the company's
ability to obtain or maintain patent or other proprietary intellectual
property protection; 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 Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada conducts hundreds of clinical trials across the country seeking new
treatments for cardiovascular disease, diabetes, cancer, ophthalmology and
organ transplantation. In 2006, the Company invested over $69 million in
research and development. Novartis Pharmaceuticals Canada Inc. employs more
than 850 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in
Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer
Health Canada Inc., (including Novartis Nutrition Corporation) CIBA Vision
Canada Inc. and Sandoz Canada Inc. For further information about Novartis
Canada, please consult http://www.novartis.ca.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. We are strengthening our
medicine-based portfolio, which is focused on strategic growth platforms in
innovation-driven pharmaceuticals, high-quality and low-cost generics, human
vaccines and leading self-medication OTC brands. Novartis is the only company
with leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 101,000 associates
and operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
(*)Diovan is a registered trademark.
1. Mochizuki S et al. Valsartan in a Japanese population with
hypertension and other cardiovascular disease (Jikei Heart Study): a
randomized, open-label, blinded endpoint morbidity-mortality study.
The Lancet 2007; 369:1431-1439.
2. Statistics Canada, Causes of Death 2002. Released 2004.
3. Statistics and Background Information - Stroke Statistics. The Heart &
Stroke Foundation Web site. Available at:
Accessed April 27, 2007.
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