First Controlled Large-Scale Intervention Angiotensin Receptor Blocker (ARB) Trial in a Japanese Population, JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and Protection of Organs with Valsartan

First Controlled Large-Scale Intervention Angiotensin Receptor Blocker (ARB) Trial in a Japanese Population, JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and Protection of Organs with Valsartan

April 27, 2007

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


    TOKYO, April 27 /Xinhua-PRNewswire/ -- 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
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