Comparison Between Valsartan and Amlodipine Regarding Cardiovascular Morbidity and Mortality in Hypertensive Patients With Glucose Intolerance - NAGOYA HEART Study


The goal of the trial was to compare treatment with valsartan compared with amlodipine among patients with hypertension and diabetes (or impaired glucose tolerance).


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).


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.


Presented by Dr. Toyoaki Murohara at the ACC.11/i2 Summit, New Orleans, LA, April 5, 2011.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Hypertension

Keywords: Hemoglobin A, Glycosylated, 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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