Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study: Rationale and design

Toshio Ogihara, Takao Saruta, Hiroaki Matsuoka, Kazuaki Shimamoto, Toshiro Fujita, Kazuyuki Shimada, Yutaka Imai, Masaru Nishigaki, Kenjiro Kikuchi, Sadayoshi Ito, Tanenao Etoh, Tutomu Imaizumi, Genjiro Kimura, Shuichi Takishita, Hirotsugu Ueshima, Hiromi Rakugi

Research output: Contribution to journalArticlepeer-review

27 Citations (Scopus)

Abstract

Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5 /1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

Original languageEnglish
Pages (from-to)657-661
Number of pages5
JournalHypertension Research
Volume27
Issue number9
DOIs
Publication statusPublished - 2004 Sep

Keywords

  • Cardiovascular events
  • Clinical trial
  • Isolated systolic hypertension
  • Valsartan

ASJC Scopus subject areas

  • Internal Medicine
  • Physiology
  • Cardiology and Cardiovascular Medicine

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