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MIDAS, the Multicenter Isradipine/Diuretic Atherosclerosis Study. Design features and baseline data
1Department of Preventive Medicine, University of Tennessee, Memphis 38163.
Insights
The Multicenter Isradipine/Diuretic Atherosclerosis Study (MIDAS) compared isradipine and hydrochlorothiazide for hypertension. It assessed their impact on carotid artery atherosclerosis progression in hypertensive patients.
Area of Science:
- Cardiology
- Pharmacology
- Vascular Medicine
Background:
- Hypertension is a major risk factor for atherosclerosis.
- Controlling blood pressure is crucial for preventing cardiovascular events.
- Early detection and management of carotid artery atherosclerosis are important.
Purpose of the Study:
- To compare the effectiveness of isradipine and hydrochlorothiazide in managing hypertension.
- To evaluate the impact of these antihypertensive treatments on the progression of early extracranial carotid artery atherosclerosis.
- To assess the role of enalapril as an add-on therapy for uncontrolled hypertension.
Main Methods:
- Randomized, double-blind, active-control trial (MIDAS study) involving 883 hypertensive patients.
- Treatment regimens included isradipine (2.5-5 mg BID) or hydrochlorothiazide (12.5-25 mg BID).
- Patients with uncontrolled blood pressure received open-label enalapril (2.5-10 mg BID).
- Inclusion criteria: age >40, carotid atherosclerosis (1.3-3.5 mm thickness), diastolic BP 90-115 mm Hg, LDL 130-189 mg/dL.
- Monitoring included blood pressure, side effects, B-mode ultrasound of carotid arteries, ECG, and quality-of-life assessments.
Main Results:
- The study enrolled 883 patients to evaluate isradipine versus hydrochlorothiazide.
- Regular monitoring of blood pressure, atherosclerosis progression via ultrasound, ECG, and quality of life was conducted.
- Add-on therapy with enalapril was used for patients with uncontrolled hypertension.
Conclusions:
- The MIDAS study provides data on the comparative effectiveness of isradipine and hydrochlorothiazide in hypertensive patients.
- It investigates the influence of these treatments on carotid artery atherosclerosis progression.
- Findings contribute to understanding hypertension management strategies for cardiovascular risk reduction.
Abstract:
The Multicenter Isradipine/Diuretic Atherosclerosis Study (MIDAS) is a randomized, double-blind, active-control trial to compare the effectiveness of two treatment regimens for the control of hypertension in reducing the rate of progression of early extracranial carotid artery atherosclerosis in hypertensive patients. The two double-blind treatment regimens are 2.5 or 5 mg isradipine twice daily and 12.5 mg or 25 mg hydrochlorothiazide twice daily. Patients whose blood pressure is not controlled with either of these regimens will receive, in addition to the highest tolerated dose of the blinded drug, 2.5 to 10 mg open-label enalapril twice daily. The MIDAS study has enrolled 883 patients to treatment with either isradipine or hydrochlorothiazide. Inclusion criteria included men and women over the age of 40 years, the presence of an atherosclerotic lesion in the extracranial carotid artery demonstrated on B-mode ultrasound scanning (maximum thickness between 1.3 and 3.5 mm), an average sitting diastolic blood pressure between 90 and 115 mm Hg, and low-density lipoprotein levels between 130 and 189 mg/dL. An assessment of each patient's blood pressure and any side effects is made every three months; a B-mode ultrasound examination of the carotid arteries was performed at baseline and every six months thereafter; an electrocardiogram was carried out at baseline and once a year thereafter; and a brief quality-of-life assessment was made at baseline and every year thereafter.