C. Raina Elley, MBChB, PhD; Vanessa Selak, MBChB, MPH
In patients with type 2 diabetes who are at high cardiovascular (CV) risk, does intensive antihypertensive therapy reduce major CV events more than standard therapy?
Randomized controlled trial (Action to Control Cardiovascular Risk in Diabetes blood pressure trial [ACCORD BP]). ClinicalTrials.gov NCT00000620.
Open-label treatment with blinded outcome adjudication committee.*
Mean 4.7 years.
77 centers in the USA and Canada.
4733 patients 40 to 79 years of age (mean age 62 y, 52% men) who had type 2 diabetes; glycated hemoglobin level ≥ 7.5%; CV disease or, if ≥ 55 years of age, risk factors for CV disease; systolic blood pressure (SBP) 130 to 180 mm Hg on ≤ 3 antihypertensive drugs; and the equivalent of a 24-hour protein excretion rate < 1.0 g. Exclusion criteria included body mass index > 45 kg/m2, serum creatinine level > 133 µmol/L (1.5 mg/dL), and other serious illness.
Intensive antihypertensive therapy targeting SBP < 120 mm Hg (n = 2362) or standard therapy targeting SBP < 140 mm Hg (n = 2371). All patients were also randomized to intensive or standard glycemic control in a 2 × 2 factorial manner.
Primary outcome was a composite of major CV events (myocardial infarction, stroke, or CV death). Secondary outcomes included a composite of major coronary disease events (fatal coronary event, myocardial infarction, or unstable angina), death from any cause, and adverse events. The trial had 94% power to detect a 20% relative reduction in the primary outcome (α = 0.05).
99% (intention-to-treat analysis).
Mean SBP was reduced from 139 mm Hg at baseline to 119 mm Hg at 1 year in the intensive-therapy group and 134 mm Hg in the standard-therapy group. These levels were maintained throughout the trial. Intensive therapy did not reduce major CV events or death, except stroke (Table). Patients in the intensive-therapy group were more likely to have serious adverse events attributable to antihypertensive medications (3.3% vs 1.3%), hypokalemia (2.1% vs 1.1%), elevated serum creatinine levels (24% vs 15%), and low estimated glomerular filtration rate (4.2% vs 2.2%). However, they were less likely to have macroalbuminuria (6.6% vs 8.7%).
In patients with type 2 diabetes at high cardiovascular (CV) risk, intensive antihypertensive therapy did not reduce a composite of major CV events more than standard therapy.
Intensive vs standard blood pressure control to prevent cardiovascular (CV) events in type 2 diabetes†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from hazard ratio and control event rate in article.
‡Myocardial infarction, stroke, or CV death.
§Fatal coronary event, myocardial infarction, or unstable angina.
Elley CR, Selak V. Intensive blood pressure control did not prevent major CV events more than standard control in type 2 diabetes. Ann Intern Med. ;153:JC1–4. doi: 10.7326/0003-4819-153-2-201007200-02004
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Published: Ann Intern Med. 2010;153(2):JC1-4.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism, Hypertension.
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