Study Design

Study Design:

Patients Screened: 54,288
Patients Enrolled: 6,083
Mean Follow Up: median 4.1 years
Mean Patient Age: 65-84 years
Female: 51

Patient Populations:

Average SBP of at least 160 mm Hg or average DBP of at least 90 mm Hg (if SBP was at least 140 mm Hg); absence of recent cardiovascular events in prior 6 months

Exclusions:

Life-threatening illness, contraindication to an ACE inhibitor or diuretic, a plasma creatinine concentration of > 2.5 mg/dL, malignant hypertension, or dementia

Primary Endpoints:

All cardiovascular events or death from any cause. All cardiovascular events defined as MI, coronary events associated with therapeutic procedures involving the coronary arteries, heart failure, acute occlusion of a major feeding artery in any vascular bed other than cerebral or coronary, dissecting or ruptured aortic aneurysm, stroke or TIA

Secondary Endpoints:

First cardiovascular event; individual components of composite

Drug/Procedures Used:

Patients were randomized to either open-label ACE inhibitor therapy (n=3,044) or diuretic therapy (n=3,039). The ACE inhibitor enalapril and the diuretic hydrochlorothiazide were recommended as initial therapy; however, the choice of the specific agent and dose was made by the family practitioner. The goal the reduction was SBP by at least 20 mm Hg to less than 160 mm Hg, with a further reduction to less than 140 mm Hg if tolerated, and a reduction of DBP by at least 10 mm Hg to less than 90 mm Hg, with a further reduction to less than 80 mm Hg.

Concomitant Medications:

Calcium-channel blockers (22.9% in ACE arm and 24.9% in diuretic arm), beta-blockers (10.8% and 13.7%, respectively), and angiotensin-receptor blockers (14.0% and 12.4%, respectively).