Asia PR News

TOKYO, April 27 /Xinhua-PRNewswire-AsiaNet/ –

JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and
Protection of Organs with Valsartan

Unprecedented Evidence for the Effectiveness of Hypertension Treatment
Valsartan in Preventing Cardiovascular Events in Japanese Patients

The clinical outcomes of the JIKEI HEART Study, the large-scale clinical
trial headed by the Jikei University School of Medicine, was today published in
the internationally renowned medical journal The Lancet. The study, involving
more than 3,000 patients, is one of the largest cardiovascular intervention
trials conducted in a Japanese population under realistic clinical settings.
It also is the first large-scale study evaluating the benefits of the ARB,
valsartan, in Japanese patients.

In the study, valsartan was added to conventional therapy to control blood
pressure and protect against cardiovascular events and stroke. The results
showed significant benefit with the use of valsartan, including a 39% decrease
in cardiovascular events and a 40% decrease in stroke compared to conventional
non-ARB therapy. Initiated in 2001, the JIKEI HEART Study was terminated
earlier than anticipated at the request of the Data and Safety Monitoring Board
due to superior outcomes for the valsartan group over the control group.

"Treatment of hypertension needs to account for blood pressure control but
also should take into account the prevention of cardiovascular diseases over an
extended period," said Seibu Mochizuki, M.D., PhD, formerly of Jikei University
School of Medicine, chief investigator of the JIKEI HEART Study. "In the JIKEI
HEART Study we accomplished both — we achieved the lowest blood pressure value
ever set in a morbidity/mortality outcomes trial and saw tremendous benefit for
the valsartan arm in reducing the risk of cardiovascular events as well as
stroke. Because of this, valsartan will play an important role in treating
hypertension as it has been shown to lower blood pressure while being highly
protective of end organs."

In the JIKEI HEART Study, treatment was initiated in a population with an
average starting blood pressure of 139/81 mmHg — already below the national
guideline level for hypertension without comorbidities. The blood pressure
target was set at 130/80 mmHg. The non-ARB group achieved 132/78 mmHg and the
valsartan group achieved 131/77 mmHg. The valsartan group also showed a
significant drop in composite cardiovascular events: the primary endpoint
cardiovascular events were compared between the groups with the valsartan-added
group exhibiting significant relative reductions, including a 65% reduction in
angina pectoris, 46% in heart failure and 81% in aortic dissection. These
benefits cannot be entirely explained by differences in blood pressure
control.

"We are very proud that the University has led yet another landmark,
large-scale clinical study. We are equally proud that the important findings
of the JIKEI HEART Study were published in the prestigious general medical
journal The Lancet, which also marks the 120-year anniversary of our first
large-scale trial on beriberi published in the same medical journal," said
Satoshi Kurihara, President, Jikei University School of Medicine. "In
accordance with our mission of patient-centered medical care, the JIKEI HEART
Study provides invaluable clinical insight into current and future treatments
for the benefit of patients. We are grateful to the patients for their
cooperation, and the physicians who ensured a high level of accuracy with a
patient follow-up rate of 99%. The design of the physician-lead study provides
a direction for future clinical investigations while attaining a high level of
international commendation."

About the large-scale clinical JIKEI HEART Study

The JIKEI HEART Study was a multi-center comparative study with a
prospective randomized open-label blinded endpoint (PROBE) design conducted by
physicians. The study involved 3,081 Japanese patients aged 20 to 79 with
hypertension, ischemic heart disease or congestive heart failure. The primary
endpoint was the onset of new or recurrent stroke, new or transient ischemic
attack, hospitalization for congestive heart failure or angina pectoris, heart
attack, aortic dissection, lower limb arterial obstruction, doubling of serum
creatinine, or transition to dialysis. At the start of the clinical study, as
well as during the course of the study, blood pressure and heart rate did not
differ between the valsartan regime and the control regime.

The chief investigator was Seibu Mochizuki, M.D., PhD, Division of
Cardiology, Department of Internal Medicine, Jikei University School of
Medicine, and the joint chief investigator was Bjorn Dahlof, Associate
Professor, Department of Medicine, University of Goteborg Sahlgrenska
University Hospital, Sweden.

The Jikei University School of Medicine

The Jikei University School of Medicine has its origins in the Sei-I-Kwai
Koshujo (Medical Training School), the precursor to the University, which was
founded in 1881 by Kenehiro Takaki. It is the oldest medical school in Japan.
The Jikei University School of Medicine is currently positioned as one of the
four educational institutions operated by the University, consisting of the
Faculty of Medicine, the Medical Research department of the graduate school,
four University hospitals, a clinic and the Research Center for Medical
Sciences. At the four University hospitals there are approximately 2,600 beds
and approximately 7,500 outpatients visit daily, making them the largest
university hospitals in Japan.

In education, research and medical care, the Jikei University School of
Medicine always adopts the founding spirit of Kanehiro Takaki of treating
patients as human beings suffering from an illness, rather than examining them
as research material. The University also devotes itself to the promotion of
clinical research, of which Takaki is said to be the originator.

Media contact:

Elissa Campbell
Cosmo Public Relations
Tel: +81-90-9821-5654
Email: campbelle@cosmopr.co.jp

SOURCE Jikei University School of Medicine