Effects of intensive blood-pressure control in type 2 diabetes mellitus.


ACCORD Study Group, Cushman WC, Evans GW, Byington RP, et al.
N Engl J Med. 2010;362(17):1575-1585. 

The blood-pressure (BP) arm of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study evaluated the effects of intensive BP-control (<120 mm Hg systolic BP [SBP]) on cardiovascular disease (CVD) events among high-risk subjects with type 2 diabetes.  

Subjects (N=4,733) were eligible to participate in ACCORD BP if they met the following criteria: SBP between 130-180 mm Hg, taking ≤3 antihypertensives, and <1.0 g 24-hour protein exchange rate. Study participants were randomized to intensive (SBP <120 mm Hg) or standard (SBP <140 mm Hg) therapy. All BP-lowering treatment regimens included currently available antihypertensive therapies demonstrated to reduce CVD events among those with diabetes. BP assessment was conducted once/month for 4 months and every 2 months thereafter for intensive therapy, and at months 1 and 4 and every 4 months thereafter for standard therapy. At baseline, mean SBP was 139.2 mm Hg and mean diastolic BP was 76.0 mm Hg, and the mean age of subjects was 62.2 years. Of those enrolled, 47.7% were female and 33.7% had history of a CVD event.  

The primary outcome was first occurrence of major CV event, including nonfatal myocardial infarction, nonfatal stroke, or death from CV causes. Mean follow-up time for the primary outcome was 4.7 years. Results:  

  • After 1 year of therapy, average SBP at the 4-month visit was 119.3 mm Hg (95% confidence interval [CI], 118.9 to 119.7) among subjects receiving intensive therapy vs 133.5 mm Hg (95% CI, 133.1 to 133.8) among those receiving standard therapy (between-group difference, 14.2 mm Hg; 95% CI, 13.7 to 14.7).
    • Mean diastolic BP was 64.4 mm Hg for intensive therapy (95% CI, 64.1 to 64.7) and 70.5 mm Hg for standard therapy (95% CI, 70.2 to 70.8) (between-group difference, 6.1 mm Hg; 95% CI, 5.7 to 6.5)  
     
  • Lower BP rates observed among subjects receiving intensive therapy were correlated with a greater exposure to drugs from every class.
  • Significantly higher rates of serious adverse events were observed in the intensive-therapy group (3.3% vs 1.3% among those receiving standard therapy; P<0.001); rates of hypokalemia and elevations in serum creatinine level were also increased with intensive therapy.
  • Rates of the primary outcome were 1.87%/year in the intensive-therapy group vs 2.09%/year in the standard-therapy group (hazard ratio [HR] with intensive therapy, 0.88; 95% CI, 0.73 to 1.06; P=0.20); between-group difference was not significant.
  • With regard to prespecified secondary outcomes, rates of death from any cause were 1.28%/year with intensive therapy vs 1.19%/year with standard therapy (HR with intensive therapy, 1.07; 95% CI, 0.85 to 1.35; P=0.55). Rates of death from CV causes were 0.52%/year with intensive therapy vs 0.49%/year with standard therapy (HR, 1.06; 95% CI, 0.74 to 1.52; P=0.74).

 

September 2012  

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Last Modified: 1/9/2013