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Table 1—

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

ACCORDADVANCEVADT
Participant characteristics    
    n 10,251 11,140 1,791 
    Mean age (years) 62 66 60 
    Duration of diabetes (years) 10 11.5 
    Sex (% male/female) 39/61 42/58 97/3 
    History of CVD (%) 35 32 40 
    BMI (kg/m232 28 31 
    Median baseline A1C (%) 8.1 7.2 9.4 
    On insulin at baseline (%) 35 1.5 52 
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 arms Multiple drugs added to gliclizide vs. multiple drugs with no gliclizide Multiple drugs in both arms 
    Management of other risk factors Embedded blood pressure and lipid trials Embedded blood pressure trial Protocol for intensive treatment in both arms 
On-study characteristics    
    Median duration of follow-up (years) 3.5 (terminated early) 5.6 
    Achieved median A1C (%) (I vs. S)* 6.4 vs. 7.5 6.3 vs. 7.0 6.9 vs. 8.5 
    On insulin at study end (%) (I vs. S)* 77 vs. 55* 40 vs. 24 89 vs. 74 
    On TZD at study end (%) (I vs. S)* 91 vs. 58* 17 vs. 11 53 vs. 42 
    On statin at study end (%) (I vs. S)* 88 vs. 88* 46 vs. 48 85 vs. 83 
    On aspirin at study end (%) (I vs. S)* 76 vs. 76* 57 vs. 55 88 vs. 86 
    Smokers at study end (%) 10 
    Mean blood pressure at study end (mmHg)    
Intensive glycemic control arm 126/67 136/74 127/68 
Standard glycemic control arm 127/68 138/74 125/69 
    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 arm 16.2 2.7 21.2 
Standard glycemic control arm 5.1 1.5 9.9 
Outcomes    
    Definition of primary outcome Nonfatal MI, nonfatal stroke, CVD death Microvascular plus macrovascular (nonfatal MI, nonfatal stroke, CVD death) outcomes Nonfatal 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) 
ACCORDADVANCEVADT
Participant characteristics    
    n 10,251 11,140 1,791 
    Mean age (years) 62 66 60 
    Duration of diabetes (years) 10 11.5 
    Sex (% male/female) 39/61 42/58 97/3 
    History of CVD (%) 35 32 40 
    BMI (kg/m232 28 31 
    Median baseline A1C (%) 8.1 7.2 9.4 
    On insulin at baseline (%) 35 1.5 52 
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 arms Multiple drugs added to gliclizide vs. multiple drugs with no gliclizide Multiple drugs in both arms 
    Management of other risk factors Embedded blood pressure and lipid trials Embedded blood pressure trial Protocol for intensive treatment in both arms 
On-study characteristics    
    Median duration of follow-up (years) 3.5 (terminated early) 5.6 
    Achieved median A1C (%) (I vs. S)* 6.4 vs. 7.5 6.3 vs. 7.0 6.9 vs. 8.5 
    On insulin at study end (%) (I vs. S)* 77 vs. 55* 40 vs. 24 89 vs. 74 
    On TZD at study end (%) (I vs. S)* 91 vs. 58* 17 vs. 11 53 vs. 42 
    On statin at study end (%) (I vs. S)* 88 vs. 88* 46 vs. 48 85 vs. 83 
    On aspirin at study end (%) (I vs. S)* 76 vs. 76* 57 vs. 55 88 vs. 86 
    Smokers at study end (%) 10 
    Mean blood pressure at study end (mmHg)    
Intensive glycemic control arm 126/67 136/74 127/68 
Standard glycemic control arm 127/68 138/74 125/69 
    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 arm 16.2 2.7 21.2 
Standard glycemic control arm 5.1 1.5 9.9 
Outcomes    
    Definition of primary outcome Nonfatal MI, nonfatal stroke, CVD death Microvascular plus macrovascular (nonfatal MI, nonfatal stroke, CVD death) outcomes Nonfatal 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.

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