• Takahisa Sawada, Hiroyuki Yamada, Björn Dahlöf, Hiroaki Matsubara, and KYOTO HEART Study Group.
• Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine, Kyoto 602-8566, Japan. tsawada@koto.kpu-m.ac.jp
• Eur. Heart J. 2009 Oct 1; 30 (20): 2461-9.

AimsThe objective was to assess the add-on effect of valsartan on top of the conventional treatment for high-risk hypertension in terms of the morbidity and mortality.Methods And ResultsThe KYOTO HEART Study was of a multicentre, Prospective Randomised Open Blinded Endpoint (PROBE) design, and the primary endpoint was a composite of fatal and non-fatal cardiovascular events (clintrials.gov NCT00149227). A total of 3031 Japanese patients (43% female, mean 66 years) with uncontrolled hypertension were randomized to either valsartan add-on or non-ARB treatment. Median follow-up period was 3.27 years. In both groups, blood pressure at baseline was 157/88 and 133/76 mmHg at the end of study. Compared with non-ARB arm, valsartan add-on arm had fewer primary endpoints (83 vs. 155; HR 0.55, 95% CI 0.42-0.72, P = 0.00001).ConclusionValsartan add-on treatment to improve blood pressure control prevented more cardiovascular events than conventional non-ARB treatment in high-risk hypertensive patients in Japan. These benefits cannot be entirely explained by a difference in blood pressure control.

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