TY - JOUR
T1 - Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study
T2 - Rationale and design
AU - Ogihara, Toshio
AU - Saruta, Takao
AU - Matsuoka, Hiroaki
AU - Shimamoto, Kazuaki
AU - Fujita, Toshiro
AU - Shimada, Kazuyuki
AU - Imai, Yutaka
AU - Nishigaki, Masaru
AU - Kikuchi, Kenjiro
AU - Ito, Sadayoshi
AU - Etoh, Tanenao
AU - Imaizumi, Tutomu
AU - Kimura, Genjiro
AU - Takishita, Shuichi
AU - Ueshima, Hirotsugu
AU - Rakugi, Hiromi
PY - 2004/9
Y1 - 2004/9
N2 - 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.
AB - 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.
KW - Cardiovascular events
KW - Clinical trial
KW - Isolated systolic hypertension
KW - Valsartan
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U2 - 10.1291/hypres.27.657
DO - 10.1291/hypres.27.657
M3 - Article
C2 - 15750259
AN - SCOPUS:20844457604
VL - 27
SP - 657
EP - 661
JO - Hypertension Research
JF - Hypertension Research
SN - 0916-9636
IS - 9
ER -