학술논문
Final outcome results of the Multicenter Isradipine Diuretic Atherosclerosis Study (MIDAS): a randomized controlled trial
Document Type
Academic Journal
Author
Source
JAMA, The Journal of the American Medical Association. Sept 11, 1996, Vol. v276 Issue n10, p785, 7 p.
Subject
Language
ISSN
0098-7484
Abstract
The calcium channel blocker isradipine may increase the risk of cardiovascular events such as heart attack, stroke and chest pain in people who take the drug for hypertension. Researchers used ultrasound to measure the change in atherosclerosis in the carotid arteries of 883 people with hypertension who took isradipine or hydrochlorothiazide. There was no difference in the progression of atherosclerosis over the 3-year study. However, the incidence of major and minor cardiovascular events was greater in the group taking isradipine.
Objective.--To compare the rate of progression of mean maximum intimalmedial 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 [+ or -)SD systolic and diastolic blood pressure (SBP and DBP, respectively) of 149.7[+ or -]16.6 and 96.5[+ or -]5.1 mm Hg, age of 58.5[+ or -]8.5 years, and maximum IMT of 1.17[+ or -]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, acrtic valve replacement, and fernoral popliteal bypass graff) 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. JAMA. 1996;276:785-791
Objective.--To compare the rate of progression of mean maximum intimalmedial 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 [+ or -)SD systolic and diastolic blood pressure (SBP and DBP, respectively) of 149.7[+ or -]16.6 and 96.5[+ or -]5.1 mm Hg, age of 58.5[+ or -]8.5 years, and maximum IMT of 1.17[+ or -]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, acrtic valve replacement, and fernoral popliteal bypass graff) 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. JAMA. 1996;276:785-791