First Controlled Large-Scale Intervention Angiotensin Receptor Blocker Valsartan

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

    TOKYO, April 26 /CNW/ -- 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


For further information:

For further information: Elissa Campbell of Cosmo Public Relations for
Jikei University, +81-90-9821-5654, or

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