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.

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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