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European Heart Journal Advance Access originally published online on August 31, 2009
European Heart Journal
2009 30(20):2461-2469; doi:10.1093/eurheartj/ehp363
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

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

Takahisa Sawada1,*, Hiroyuki Yamada1, Björn Dahlöf2, Hiroaki Matsubara1 for the KYOTO HEART Study Group

1 Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine, Kajiicho 465, Kamigyoku, Kyoto 602-8566, Japan
2 Department of Medicine, Sahlgrenska University Hospital/ Östra, Göteborg, Sweden

Received 4 August 2009; accepted 13 August 2009; online publish-ahead-of-print 31 August 2009.

* Corresponding author. Tel: +81 75 251 5511, Fax: +81 75 251 5514, Email: tsawada{at}koto.kpu-m.ac.jp

See page 2427 for the commentary on this article (doi:10.1093/eurheartj/ehp364)

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 [ClinicalTrials.gov] ). 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.

Key Words: High-risk hypertension • Angiotensin receptor blockers • Cardiovascular mortality–morbidity • Valsartan


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