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Final Outcome Results of the Multicenter Isradipine Diuretic Atherosclerosis Study (MIDAS)
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1996
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HypertensionVascular DiseaseBlood PressureMean DbpStrokeVascular ImagingPublic HealthAtherosclerosisDyslipidemiaRadiologyCardiovascular ImagingFinal Outcome ResultsAntihypertensive TherapyVascular BiologyPeripheral Artery DiseasePeripheral Vascular DiseaseUrologyCardiovascular DiseaseVs HydrochlorothiazideMaximum ImtArterial DiseaseMedicineAnesthesiology
<h3>Objective.</h3> —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. <h3>Design.</h3> —Randomized, double-blind, positive-controlled trial. <h3>Setting.</h3> —Nine medical center clinics. <h3>Population.</h3> —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. <h3>Interventions.</h3> —Twice daily doses of isradipine (2.5-5.0 mg) or hydrochlorothiazide (12.5-25 mg). <h3>Main Outcome Measure (Primary End Point).</h3> —Rate of progression of mean maximum IMT in 12 carotid focal points over 3 years. <h3>Results.</h3> —There was no difference in the rate of progression of mean maximum IMT between isradipine and hydrochlorothiazide over 3 years (<i>P</i>=.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%) (<i>P</i>=.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%) (<i>P</i>=.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 (<i>P</i>=.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. <h3>Conclusion.</h3> —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.