Action to Control Cardiovascular Risk in Diabetes Blood Pressure Trial - ACCORD BP

Description:

The goal of the trial was to evaluate a target systolic blood pressure <120 mm Hg compared with <140 mm Hg among patients with type 2 diabetes.

Hypothesis:

Intensive blood pressure lowering would be effective in preventing cardiovascular events.

Study Design

  • Parallel

Patients Enrolled: 4,733
Mean Follow Up: 4.7 years
Mean Patient Age: 62 years
Female: 48%

Patient Populations:

  • Patients with type 2 diabetes with an HbA1c &ge;7.5%
  • Age 40-79 years with clinical cardiovascular disease or age 55-79 years with subclinical cardiovascular disease or at least two additional cardiovascular risk factors
  • Systolic blood pressure 130-180 mm Hg on 0-1 antihypertensive medications, 130-170 mm Hg on two medications, or 130-160 mm Hg on three medications

Exclusions:

  • Creatinine >1.5 mg/dl
  • Marked proteinuria

Primary Endpoints:

  • First occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke

Drug/Procedures Used:

Half of the patients within the initial ACCORD trial with type 2 diabetes were randomized to a goal systolic blood pressure <120 mm Hg (n = 2,362) versus <140 mm Hg (n = 2,371).

The other half of the patients within the initial ACCORD trial were randomized to fenofibrate plus statin therapy versus placebo plus statin therapy.

Principal Findings:

Overall 4,733 patients were enrolled. The mean age was 62 years, 48% were women, previous cardiovascular event was present in 34%, mean systolic blood pressure was 139 mm Hg, and mean glycated hemoglobin (HbA1c) was 8.3%.

At 1 year, mean systolic blood pressure was 119 mm Hg in the intensive group versus 134 mm Hg in the standard group, and mean number of antihypertensives was 3.4 versus 2.1, respectively.

The annual rate of cardiovascular mortality, myocardial infarction, or stroke was 1.9% versus 2.1% (p = 0.20), all-cause mortality was 1.3% versus 1.2% (p = 0.55), nonfatal myocardial infarction was 1.1% versus 1.3% (p = 0.25), and stroke was 0.3% versus 0.5% (p = 0.01), respectively, for intensive versus standard blood pressure target.

Cumulative serious adverse events were 3.3% versus 1.3% (p < 0.001), hypokalemia was 2.1% versus 1.1% (p = 0.01), and elevated serum creatinine was 12.9% versus 8.4% (p < 0.001), respectively.

Interpretation:

Among patients with type 2 diabetes at high risk for cardiovascular events, a goal systolic blood pressure <120 mm Hg was not superior to a goal <140 mm Hg. This intensive target did not reduce composite cardiovascular events; however, there was a small reduction in any stroke from 0.5% to 0.3%. In the intensive systolic blood pressure group, there were more serious adverse events, hypokalemia, and elevated serum creatinine.

These findings contrast with the UKPDS and HOT trials, which documented benefit from blood pressure reduction; however, the mean systolic blood pressure in the intensively treated groups in those trials was 144 mm Hg.

References:

The ACCORD Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-1585.

Presented by Dr. William Cushman at the ACC.10/i2 Summit, Atlanta, GA, March 2010.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Nonstatins, Novel Agents, Statins, Hypertension

Keywords: Fenofibrate, Hemoglobin A, Glycosylated, Myocardial Infarction, Stroke, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Diabetes Mellitus, Type 2, Hypokalemia, Blood Pressure, Creatinine, Hypertension, Systole


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