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| |  Intensive BP Lowering Fails to Show Cardiovascular Benefit in High-Risk Patients With Diabetes: Presented at ACC By Walter Alexander ATLANTA -- March 15, 2010 -- In patients with type 2 diabetes at high risk for cardiovascular events, the rate of a composite outcome of fatal and nonfatal major cardiovascular events was not reduced by targeting a systolic blood pressure of <120 mm Hg as compared with targeting <140 mm Hg. These are the results of the Action to Control Cardiovascular Risk in Diabetes Blood Pressure (ACCORD BP) trial, presented here on March 14 at the 59th Annual Scientific Sessions of the American College of Cardiology (ACC) during a Late-Breaking presentation. “The ACCORD BP Trial results provide no conclusive evidence that a strategy targeting normal systolic blood pressure compared with a standard systolic blood pressure goal reduces a composite of major cardiovascular events in high-risk patients with type 2 diabetes, in the setting of good glycaemic control,” said William C. Cushman, MD, Veterans Affairs Medical Center, Memphis, Tennessee. In the multicentre ACCORD BP trial, high-risk patients with type 2 diabetes were randomised to either a systolic blood pressure goal of <120 mm Hg (n = 2,362) or <140 mm Hg (n = 2,371). Initial therapy in the intensive group was a thiazide-type diuretic plus an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, or a beta blocker. After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. Rates for the primary outcome of a major cardiovascular event (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) were similar between groups, occurring at an annual rate of 1.87% in the intensive-therapy group and at a rate of 2.09% in the standard-therapy group (hazard ratio [HR] with intensive therapy = 0.88; 95% confidence interval [CI], 0.73-1.06; P = .20). Death from any cause was reported at an annual rate of 1.28% in the intensive therapy group and at 1.19% in the standard therapy group (HR = 1.07; 95% CI, 0.85-1.35; P = .55). However, annual stroke rates -- a prespecified secondary outcome -- were lower in the intensive-therapy group (0.32%), compared with the standard-therapy group (0.53%; HR = 0.59; 95% CI, 0.39-0.89; P = .01). During an interview, Dr. Cushman noted that most strokes were ischaemic and that transient ischaemic attacks were excluded from the analysis. “We have not yet analysed stroke subgroups, but it may be that the elderly or African Americans or some other group may show enough benefit to be considered clinically important,” he said. However, Dr. Cushman pointed out that the number-needed-to-treat to prevent 1 stroke with intensive treatment over 5 years was 89. The primary research question was whether, in the context of good glycaemic control, an intensive therapeutic strategy that targets a systolic blood pressure of <120 mm Hg reduces the rate of cardiovascular events more than a standard intervention that targets a systolic blood pressure of <140 mm Hg. Patients (mean age, 62 years) had type 2 diabetes (Hb A1C >=7.5%, age 40-79) plus clinically confirmed, or evidence of, cardiovascular disease or at least 2 additional cardiovascular disease risk factors. In addition, systolic blood pressure had to be 130 to 180 mm Hg in those taking 0 to 1 antihypertensive medications, 130 to 170 mm Hg among those on 2 medications, or 130 to 160 mm Hg for those on 3 medications. Those with serum creatinine >1.5 mg/dL or marked proteinuria were excluded. Serious adverse events attributed to antihypertensive treatment were significantly more common in the intensive therapy group, occurring in 77 participants in the intensive-therapy group (3.3%) and in 30 in the standard-therapy group (1.3%; P < .001). Hypotension was reported in 17 patients in the intensive-therapy group and in 1 patient in the standard-therapy group. [Presentation title: Effects of Intensive Blood Pressure Control on Cardiovascular Events in Type 2 Diabetes Mellitus: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial. Late-Breaking Clinical Trials I]
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