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September 11, 1996

Final Outcome Results of the Multicenter Isradipine Diuretic Atherosclerosis Study (MIDAS)A Randomized Controlled Trial

Author Affiliations

From Department of Internal Medicine (Dr Borhani and Ms Borhani), and Division of Cardiovascular Medicine (Dr Kappagoda), School of Medicine, University of California at Davis; Department of Family and Community Medicine, School of Medicine, University of Nevada, Reno (Dr Borhani and Ms Borhani); Division of Vascular Ultrasound Research (Drs Bond and Mercuri), and Section of Nephrology, Department of Internal Medicine (Drs Buckalew and Rocco), The Bowman Gray School of Medicine, Winston-Salem, NC; Clinical Trials Unit, Miami (Fla) Heart Research Institute (Dr Canossa-Terris); Circulatory Disease Center, Augusta (Ga) Preventive Cardiology Inc (Dr Carr); Scientific Application Co Inc, Birmingham, Ala (Dr Schnaper); and Division of Endocrinology, Metabolism and Hypertension, Wayne State University, Detroit, Mich (Dr Sowers).

JAMA. 1996;276(10):785-791. doi:10.1001/jama.1996.03540100029024

Objective.  —To compare the rate of progression of mean maximum intimal-medial thickness (IMT) in carotid arteries, using quantitative B-mode ultrasound imaging, during antihypertensive therapy with isradipine vs hydrochlorothiazide.

Design.  —Randomized, double-blind, positive-controlled trial.

Setting.  —Nine medical center clinics.

Population.  —A total of 883 patients with baseline mean ±SD systolic and diastolic blood pressure (SBP and DBP, respectively) of 149.7±16.6 and 96.5±5.1 mm Hg, age of 58.5±8.5 years, and maximum IMT of 1.17±0.20 mm.

Interventions.  —Twice daily doses of isradipine (2.5-5.0 mg) or hydrochlorothiazide (12.5-25 mg).

Main Outcome Measure (Primary End Point).  —Rate of progression of mean maximum IMT in 12 carotid focal points over 3 years.

Results.  —There was no difference in the rate of progression of mean maximum IMT between isradipine and hydrochlorothiazide over 3 years (P=.68). There was a higher incidence of major vascular events (eg, myocardial infarction, stroke, congestive heart failure, angina, and sudden death) in isradipine (n=25; 5.65%) vs hydrochlorothiazide (n=14; 3.17%) (P=.07), and a significant increase in nonmajor vascular events and procedures (eg, transient ischemic attack, dysrhythmia, aortic valve replacement, and femoral popliteal bypass graft) in isradipine (n=40; 9.05%) vs hydrochlorothiazide (n=23; 5.22%) (P=.02). At 6 months, mean DBP decreased by 13.0 mm Hg in both groups, and mean SBP decreased by 19.5 mm Hg in hydrochlorothiazide and 16.0 mm Hg in isradipine (P=.002); the difference in SBP between the 2 groups persisted throughout the study but did not explain the increased incidence of vascular events in patients treated with isradipine.

Conclusion.  —The rate of progression of mean maximum IMT in carotid arteries, the surrogate end point in this study, did not differ between the 2 treatment groups. The increased incidence of vascular events in patients receiving isradipine compared with hydrochlorothiazide is of concern and should be studied further.