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Cardiovascular Events Reduced in Japanese JIKEI Study With Valsartan: Presented at WCC

By Ed Susman

BARCELONA, SPAIN -- September 5, 2006 -- Addition of the angiotensin receptor blocker (ARB) valsartan to an antihypertensive regimen markedly reduced adverse cardiovascular events in a study of Japanese patients, researchers reported here at the European Society of Cardiology World Congress of Cardiology (WCC).

Blood pressure control was equal in both arms of the study, but the difference in outcomes was substantial and there were significant decreases in cardiovascular events with valsartan, specifically stroke, bouts of angina, heart failure, and the need for hospitalization due to cardiac events, researchers said.

"For the first time, the clinical value of valsartan added to the benefits of blood pressure control, are extended to an Asian population," said Bjorn Dahlof, MD, associate professor of medicine, Sahlgrenska University Hospital/Ostra, University of Gothenburg, Gothenburg, Sweden. "We also believe that these results -- seen in previous studies in other populations -- reach back again to be generalizable to Western communities."

In a presentation on September 6^th, Dr. Dahlof said the results indicate that aggressive blood pressure control is important "but also which blood pressure drug is the best choice to prevent outcomes."

Dr. Dahlof is cochair of the JIKEI Heart Study, based at Jikei University School of Medicine, Tokyo, Japan.

The trial enrolled 3,081 patients (one third women). The subjects were assigned to receive either valsartan or placebo on top of their current antihypertensive therapy, which could not include an ARB. Dr. Dahlof said the comparator medications were mainly calcium-channel blockers, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors. Both groups of patients were able to reduce their blood pressure levels to a similar extent.

Results also showed that patients on valsartan had a 39% relative-risk reduction in the primary endpoint of the study, a composite of cardiovascular mortality and morbidity. After 48 months, 92 events had occurred among patients on valsartan as opposed to 149 events in patients not taking the drug. That difference was significant at the P = .00021 level.

The researchers also observed a 40% reduction in new or recurrent strokes. After 48 months, 29 events had occurred among patients on valsartan as opposed to 48 events in patients not on the drug. That difference was significant at the P = .028 level.

There was also a 46% decline in the need for hospitalization due to heart failure. After 48 months, 19 events had occurred among patients on valsartan as opposed to 36 events in patients not on the drug. That difference was significant at the P = .029 level.

In addition, the need to be hospitalized due to angina pectoris decreased by 65%. After 48 months, 19 events had occurred among patients on valsartan as opposed to 53 events in patients not taking the drug. That difference was significant at the P = .000007 level.


[Presentation title: Japanese Investigation of Kinetic Evaluation in Hypertensive Event Study (JIKEI Heart Study): A Morbidity-Mortality Study With valsartan in a Japanese Population With Hypertension and Other Cardiovascular Disease Manifestations.]

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