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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: PS.3.01

Background: Evidence from randomized clinical trials does not support treating systolic blood pressure below 135–140 mm Hg in participants with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (<120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes and cardiovascular disease or additional risk factors. Methods: 4,733 participants with type 2 diabetes (median duration 10 years), age 40–88 years (mean 62), 34% with existing cardiovascular disease, and systolic pressure 130–180 mm Hg (mean 139), were randomly assigned to intensive or standard therapy targeting systolic pressure < 120 mm Hg or <140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death during 4–8 years' treatment. Results: After 1 year, systolic pressures averaged 119.3 mm Hg and 133.5 mm Hg in intensive and standard groups. Primary outcomes occurred in 208 intensive and 237 standard participants (hazard ratio [HR] = 0.88, 95% confidence interval [CI], 0.73 to 1.06; p = 0.20). Stroke, a prespecified secondary outcome, occurred in 36 intensive and 62 standard participants (HR = 0.59, 95% CI 0.39 to 0.89, p = 0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 (3.3%) intensive and 30 (1.3%) standard participants (p < 0.0001). Conclusions: These results provide no conclusive evidence that targeting normal systolic pressure compared with a standard goal reduces a composite of major cardiovascular events in high-risk patients with type 2 diabetes. Despite increased risk of serious adverse events, results for stroke suggest patients like those in ACCORD may benefit from a systolic goal of 120 mm Hg.