Hypertension Clinical Trial
To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.
BACKGROUND:
Appropriately increased interest and concern about high blood pressure as a major public
health problem coincided with the indication that the risks of hypertension-related
morbidity and mortality could be reduced by reduction of blood pressure. Consensus
suggestions that individualized approaches be used in treating patients with mild
hypertension stimulated further investigations of non-pharmacological methods. Such
investigations were also of considerable interest in relation to understanding the
physiology of blood pressure control as well as the development of less costly non-drug
therapies. Interest was heightened by information suggesting that there might be distinctly
harmful side effects related to antihypertensive drug therapy, particularly thiazide
diuretics, in some settings. Studies of non-drug therapies included dietary modifications
primarily involving weight reduction and sodium restriction with increasing recent concern
about other factors such as alcohol intake, dietary fat, calcium, magnesium, and potassium
intake.
DESIGN NARRATIVE:
Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium
placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects
into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted
to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were
withdrawn. Follow-up of each participant was for at least two years. The primary endpoint
was the proportion of subjects requiring antihypertensive medication at various points
following randomization.
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