DynaMed EBM Series 331: Intensive Systolic Blood Pressure Control Does Not Reduce Mortality in Patients With Diabetes

Current guidelines from the American Diabetes Association (ADA) and other organizations recommend a blood pressure target < 130/80 mm Hg for patients with diabetes (Diabetes Care 2010 Jan;33 Suppl 1:S11). To date, there has been little experimental data to guide blood pressure target recommendations, but a new trial directly compared two different blood pressure goals. The Action to Control Cardiovascular Risk in Diabetes blood pressure trial (ACCORD BP) compared intensive systolic blood pressure control (target < 120 mm Hg) vs. standard control (target < 140 mm Hg) in 4,733 patients. While the trial did not stipulate specific antihypertensive regimens, patients in both groups were required to receive a drug class associated with reduction in cardiovascular events in patients with diabetes (ACE inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, or diuretics). They could also receive other medications as necessary.

Mean systolic blood pressure from the end of first year to end of follow-up was 119.3 mm Hg for the intensive group and 133.5 mm Hg for the standard group. Systolic blood pressure target < 120 mm Hg does not reduce mortality or myocardial infarction but does reduce nonfatal stroke compared to target < 140 mm Hg (level 1 [mid-level] evidence). During a mean follow-up of 4.7 years, cardiovascular mortality was 2.5% in each group. There were no significant differences in all-cause mortality (6.3% vs. 6.1%), nonfatal myocardial infarction (5.3% vs. 6.2%), or heart failure (3.5% vs. 3.8%). Stroke occurred in 1.7% of the intensive group compared to 2.6% of the standard group (p = 0.01, NNT 84). However, the risk of serious adverse events from treatment was increased for the intensive group (3.3% vs. 1.3%, p < 0.001, NNH 50). Adverse events reported (not all individually significant) included hypotension, syncope, bradycardia or other arrhythmia, hyperkalemia, angioedema, and renal failure(N Engl J Med 2010 Mar 14 early online). For more information, see the hypertension treatment in patients with diabetes topic in DynaMed.

In DynaMed’s hypertension treatment in patients with diabetes topic, under Target Blood Pressure Goals — Evidence, the content is:

systolic blood pressure target < 120 mm Hg does not reduce mortality or myocardial infarction but does reduce nonfatal stroke compared to target < 140 mm Hg (level 1 [likely reliable] evidence)

• based on randomized trial
• 4,733 patients (mean age 62 years) with type 2 diabetes, HbA1c ≥ 7.5% and high risk for cardiovascular events were randomized to intensive therapy with systolic pressure target < 120 mm Hg vs. standard therapy with systolic pressure target < 140 mm Hg
• antihypertensive regimens for both groups were required to include a drug class associated with reduction in cardiovascular events in patients with diabetes
  • ACE inhibitors
  • angiotensin receptor blockers
  • beta blockers
  • calcium channel blockers
  • diuretics
• mean follow-up 4.7 years
• mean systolic blood pressure from end of first year to end of follow-up
  • 119.3 mm Hg with intensive therapy
  • 133.5 mm Hg with standard therapy
• comparing intensive therapy vs. standard therapy
  • death from cardiovascular cause in 2.5% vs. 2.5% (not significant)
  • death from any cause in 6.3% vs. 6.1% (not significant)
  • annual mortality 1.28% vs. 1.19% (not significant)
  • nonfatal myocardial infarction in 5.3% vs. 6.2% (not significant)
  • major coronary disease event (fatal coronary event, nonfatal myocardial infarction or unstable angina) in 10.7% vs. 11.48% (not significant)
  • any stroke in 1.7% vs. 2.6% (p = 0.01, NNT 84)
  • nonfatal stroke in 1.4% vs. 2.3% (p = 0.03, NNT 167)
  • annual rate of stroke 0.32% vs. 0.53% (p = 0.01, NNT 556 patient-years)
  • fatal or nonfatal heart failure in 3.5% vs. 3.8% (not significant)
  • serious adverse events attributed to antihypertensive treatment in 3.3% vs. 1.3% (p < 0.001, NNH 50)

Reference: ACCORD BP trial (N Engl J Med 2010 Mar 14 early online), editorial can be found in N Engl J Med 2010 Mar 14 early online