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valsartan in elderly isolated systolic hypertension (VALISH) study: rationale and design
Toshio Ogihara1, Takao Saruta, Hiroaki Matsuoka
1Department of Geriatric Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. ogihara@geriat.med.osaka-u.ac.jp
Insights
The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study investigates optimal systolic blood pressure targets for elderly patients. This trial aims to determine if lowering blood pressure below 140 mmHg or 150 mmHg reduces cardiovascular events.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Antihypertensive therapy reduces cardiovascular risks, but optimal blood pressure targets in elderly hypertensive patients remain unclear.
- Isolated systolic hypertension is common in the elderly, necessitating specific treatment guidelines.
Purpose of the Study:
- To compare cardiovascular event incidence between two target systolic blood pressure levels (<140 mmHg vs. <150 mmHg) in elderly patients with isolated systolic hypertension.
- To evaluate the efficacy of valsartan, an angiotensin II receptor blocker, in achieving these targets.
Main Methods:
- The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter, parallel-group trial.
- Recruitment of 3,000 elderly patients with isolated systolic hypertension, with a follow-up duration of at least 2 years.
- Valsartan is used as the initial antihypertensive drug, with treatment guided by two target systolic blood pressure levels.
Main Results:
- The study is designed with 80% power to detect differences in cardiovascular event rates between the two target blood pressure groups.
- Estimated cardiovascular event rates are 21.5/1,000 patient-years for the <140 mmHg target and 29.1/1,000 patient-years for the <150 mmHg target.
Conclusions:
- The VALISH study will provide crucial data on age-specific blood pressure targets for treating isolated systolic hypertension in the elderly.
- Findings will inform clinical guidelines regarding the management of hypertension in older populations.
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 alpha 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.
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