Nordic Diltiazem Study "NORDIL"

Completed

Phase N/A Results

Trial Description

To compare the efficacy of a calcium-channel blocker (diltiazem) with those of beta-blockers and diuretics in preventing major cardiovascular events in hypertensive patients.

Interventions

  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials

Patient Involvement

Approximately half of the eligible patients were randomized to receive diltiazem, and half to receive conventional treatment (beta-blockers, diuretics, or beta-blockers and diuretics in combination). All patients could be prescribed additional medications in a stepwise fashion to reduce diastolic blood pressure to less than 90 mmHg.

Diltiazem patients were initially prescribed 180-360 mg daily. If this did not adequately reduce blood pressure, an ACE inhibitor was added. If this was still insufficient, a diuretic or an alpha-blocker was added. If this failed, any antihypertensive could be added as a fourth step.

In the event that a thiazide diuretic or beta-blocker failed, beta-blocker patients would add a diuretic, and diuretic patients would add a beta-blocker. If this was still inadequate, an ACE inhibitor or an alpha-blocker was added. If blood pressure was still unsatisfactory, any antihypertensive except a calcium-channel blocker could be used as an adjunct.

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke, myocardial infarction (MI), cardiovascular death
Secondary Transient ischemic attack (TIA), any death, atrial fibrillation, new diabetes mellitus, congestive heart failure (CHF), any cardiac event

Sponsors

Pharamacia-Upjohn, Inc., Kalamazoo, MI