Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study

Eur Heart J. 2009 Oct;30(20):2461-9. doi: 10.1093/eurheartj/ehp363. Epub 2009 Aug 31.


Aims: The 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 results: The 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).

Conclusion: Valsartan 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Retracted Publication

MeSH terms

  • Adrenergic beta-Antagonists / therapeutic use
  • Aged
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure / drug effects
  • Cardiovascular Diseases / mortality*
  • Cardiovascular Diseases / physiopathology
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / mortality
  • Hypertension / physiopathology
  • Kaplan-Meier Estimate
  • Male
  • Prospective Studies
  • Risk Factors
  • Tetrazoles / therapeutic use*
  • Treatment Outcome
  • Valine / analogs & derivatives*
  • Valine / therapeutic use
  • Valsartan


  • Adrenergic beta-Antagonists
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Tetrazoles
  • Valsartan
  • Valine

Associated data

  • ClinicalTrials.gov/NCT00149227