TRIAL OF NONPHARMACOLOGIC INTERVENTIONS IN THE ELDERLY

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A substantial proportion (probably 30-40%) of elderly persons are being treated with BP medications. The efficacy of BP drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven but there is little doubt that such therapy can adversely effect quality of life and biochemical profile. there is a compelling rationale to (1) identify what proportion of medicated, well-controlled elderly hypertensives can be maintained (long-term; > 30 months) in the normotensive state following withdrawal of BP medications, and (2) determine whether non-pharmacologic therapy can significantly increase the proportion with a successful outcome. Nine-hundred subjects (225 in each of four centers) 65-80 yrs. with a SBP < 160 and DBP < 90 mmHg while receiving one BP medication will be enrolled in a trial to test the efficacy of weight loss and sodium restriction (alone and combined) in maintaining the normotensive state following withdrawal of antihypertensive medications. Six-hundred overweight participants will be randomly assigned to weight loss, sodium restriction, combined weight loss and sodium restriction, or attention control. Three- hundred non-overweight participants will be randomly assigned to a sodium restriction or attention control group. The attention groups will be engaged in a series of non-BP related health encounters designed to control for non-specific effects of groups contacts. Withdrawal of antihypertensive medications will be attempted following 6 weeks of intervention. the primary trial endpoint will be need for recurrent antihypertensive drug therapy. The significance of the proposed study is that our findings may identify a non-pharmacologic approach which provides a safe and well-tolerated method by which to discontinue antihypertensive drug therapy in the approximately 15 million persons > 65 years who are currently being treated with BP medications. In addition, our study will identify the proportion of elderly hypertensives who can be maintained in the normotensive state without any intervention following withdrawal of their BP medications.