Comparison Between Valsartan and Amlodipine Regarding Cardiovascular Morbidity and Mortality in Hypertensive Patients With Glucose Intolerance - NAGOYA HEART Study
Description:
The goal of the trial was to compare treatment with valsartan compared with amlodipine among patients with hypertension and diabetes (or impaired glucose tolerance).
Hypothesis:
Valsartan will reduce morbidity and mortality.
Study Design
- Randomized
- Blinded
- Parallel
Patient Populations:
- Patients 30-75 years of age with hypertension and diabetes (or impaired glucose tolerance)
Number of screened applicants: 1,168
Number of enrollees: 1,150
Duration of follow-up: median 3 years
Mean patient age: 63 years
Percentage female: 34%
Primary Endpoints:
- Composite of cardiovascular events (myocardial infarction, revascularization, stroke, heart failure admission, sudden cardiac death)
Secondary Endpoints:
- All-cause mortality
Drug/Procedures Used:
Japanese patients with hypertension and diabetes (or impaired glucose tolerance) were randomized to valsartan (n = 575) versus amlodipine (n = 575). Study medications were up-titrated to achieve target blood pressure <130/80 mm Hg.
Principal Findings:
Overall, 1,150 patients were randomized. In the valsartan group, the mean age was 63 years, 34% were women, mean body mass index was 25 kg/m2, mean blood pressure was 145/82 mm Hg, and mean glycated hemoglobin was 7.0%.
Over the follow-up period, there was no difference in blood pressure or glycated hemoglobin between the groups.
At a median of 3.2 years, the composite cardiovascular outcome occurred in 9.4% of the valsartan group versus 9.7% of the amlodipine group (hazard ratio 0.97, 96% confidence interval 0.66-1.40). Individual outcomes were similar between the groups; however, heart failure admission occurred in 0.5% of the valsartan group versus 2.6% of the amlodipine group (p = 0.01).
Interpretation:
Among Japanese patients with hypertension and diabetes, there was no difference in composite outcomes for a valsartan-based treatment of hypertension versus an amlodipine-based treatment of hypertension. The only individual outcome which favored the use of valsartan was heart failure admission.
References:
Presented by Dr. Toyoaki Murohara at the ACC.11/i2 Summit, New Orleans, LA, April 5, 2011.
Keywords: Glycated Hemoglobin A, Follow-Up Studies, Body Mass Index, Angiotensin II Type 1 Receptor Blockers, Heart Failure, Confidence Intervals, Valine, Amlodipine, Tetrazoles, Hypertension, Diabetes Mellitus
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