The study was prematurely stopped after a median observation time of 3.27 years. This was for ethical reasons because of unequivocal benefit in the valsartan group. * Compared with non-ARB arm, fewer individuals in the valsartan arm reached a primary endpoint (83 vs 155; HR 0.55, 95% CI 0.42-072,>* Differences in acute myocardial infarction (7 vs 11), heart failure (12 vs 26), arterio-sclerosis obliterance (11 vs 12), and aortic dissection (3 vs 5) were not significant. In addition, rates of all-cause mortality (22 in valsartan arm vs 32 in non-ARB arm) and cardiovascular mortality (8 vs 13) were not significant. * Blood pressure at baseline was 157/88 mmHg in the both groups. Mean blood pressure during the treatment period was 133.1/76.1 mmHg in the valsartan add-on arm and 133.3/76.0 mmHg in the non-ARB arm.

Says principal investigator Professor Hiroaki Matsubara:"The KYOTO HEART Study was first designed to evaluate whether the addition of valsartan to conventional antihypertensive treatment to improve blood pressure control influences the cardiovascular outcome in Japanese high-risk hypertensive patients. The study showed that valsartan has the additional benefits of cardiovascular event prevention for hypertensive patients in East Asia with metabolic syndrome or high-risks."

* The KYOTO HEART study is registered with ClinicalTrials, number NCT00149227

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