Nordic Diltiazem Study - NORDIL

Description:

Use of diltiazem for reduction of cardiovascular events in hypertensive patients

Hypothesis:

Calcium antagonists are a first-line treatment for hypertension. The effectiveness of diltiazem, a non-dihydropyridine calcium antagonist, in reducing cardiovascular morbidity or mortality is unclear.

Study Design

Study Design:

Patients Enrolled: 10881
Mean Patient Age: 50-74

Patient Populations:

aged 50-74 years at health centres in Norway and Sweden diastolic blood pressure >= 100 mm Hg

Primary Endpoints:

The combined primary endpoint was fatal and non-fatal stroke, myocardial infarction, and other cardiovascular death

Drug/Procedures Used:

In a prospective, randomised, open, blinded endpoint study, we enrolled 10,881 patients, aged 50-74 years, at health centres in Norway and Sweden, who had diastolic blood pressure of 100 mm Hg or more. Patients were randomly assigned to diltiazem, or diuretics, beta-blockers, or both.

Principal Findings:

Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups (reduction 20.3/18.7 vs 23.3/18.7 mm Hg; difference in systolic reduction p<0.001) A primary endpoint occurred in 403 patients in the diltiazem group and in 400 in the diuretic and beta-blocker group (16.6 vs 16.2 events per 1000 patient-years; relative risk 1.00 [95% CI 0.87-1.15], p=0.97). Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group (6.4 vs 7.9 events per 1000 patient-years; 0.80 [0.65-0.99], p=0.04) and fatal and non-fatal myocardial infarction in 183 and 157 patients (7.4 vs 6.3 events per 1000 patient-years; 1.16 [0.94-1.44], p=0.17).

Interpretation:

In this large trial of nearly 11,000 patients, the risk of the combined primary endpoint of all stroke, myocardial infarction, and other cardiovascular death was no different among patients treated with Diltiazem versus a treatment regimen including diuretics, beta-blockers, or both.

References:

Lancet. 356(9227):359-65, 2000 Jul 29.

Clinical Topics: Prevention, Statins, Hypertension

Keywords: Diltiazem, Dihydropyridines, Risk, Myocardial Infarction, Stroke, Diuretics, Hydrochlorothiazide, Hypertension, Calcium Channel Blockers


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