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.”