Table 1—

Comparison of the three trials of intensive glycemic control and CVD outcomes

ACCORDADVANCEVADT
Participant characteristics
    n10,25111,1401,791
    Mean age (years)626660
    Duration of diabetes (years)10811.5
    Sex (% male/female)39/6142/5897/3
    History of CVD (%)353240
    BMI (kg/m2)322831
    Median baseline A1C (%)8.17.29.4
    On insulin at baseline (%)351.552
Protocol characteristics
    A1C goals (%) (I vs. S)*<6.0 vs. 7.0–7.9≤6.5 vs. “based on local guidelines”<6.0 (action if >6.5) vs. planned separation of 1.5
    Protocol for glycemic control (I vs. S)*Multiple drugs in both armsMultiple drugs added to gliclizide vs. multiple drugs with no gliclizideMultiple drugs in both arms
    Management of other risk factorsEmbedded blood pressure and lipid trialsEmbedded blood pressure trialProtocol for intensive treatment in both arms
On-study characteristics
    Median duration of follow-up (years)3.5 (terminated early)55.6
    Achieved median A1C (%) (I vs. S)*6.4 vs. 7.56.3 vs. 7.06.9 vs. 8.5
    On insulin at study end (%) (I vs. S)*77 vs. 55*40 vs. 2489 vs. 74
    On TZD at study end (%) (I vs. S)*91 vs. 58*17 vs. 1153 vs. 42
    On statin at study end (%) (I vs. S)*88 vs. 88*46 vs. 4885 vs. 83
    On aspirin at study end (%) (I vs. S)*76 vs. 76*57 vs. 5588 vs. 86
    Smokers at study end (%)1088
    Mean blood pressure at study end (mmHg)
Intensive glycemic control arm126/67136/74127/68
Standard glycemic control arm127/68138/74125/69
    Weight changes (kg)
Intensive glycemic control arm+3.5−0.1+7.8
Standard glycemic control arm+0.4−1.0+3.4
    Severe hypoglycemia (participants with one or more episodes during study) (%)
Intensive glycemic control arm16.22.721.2
Standard glycemic control arm5.11.59.9
Outcomes
    Definition of primary outcomeNonfatal MI, nonfatal stroke, CVD deathMicrovascular plus macrovascular (nonfatal MI, nonfatal stroke, CVD death) outcomesNonfatal MI, nonfatal stroke, CVD death, hospitalization for heart failure, revascularization
    HR for primary outcome (95% CI)0.90 (0.78–1.04)0.9 (0.82–0.98); macrovascular 0.94 (0.84–1.06)0.88 (0.74–1.05)
    HR for mortality findings (95% CI)1.22 (1.01–1.46)0.93 (0.83–1.06)1.07 (0.81–1.42)
  • * Medication rates for ACCORD are for any use during the study. I, intensive glycemic control; S, standard glycemic control; TZD, thiazolidinedione.