TOKYO, April 26, 2007 /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 o rgans."
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 h ypertension, 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.
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