Characteristics of DPN case and control subjects
| Baseline characteristic | Discovery set (ACCORD) | Validation set (BARI 2D) | ||||
|---|---|---|---|---|---|---|
| DPN case subjects (n = 4,384) | DPN control subjects (n = 784) | P value | DPN case subjects (n = 791) | DPN control subjects (n = 158) | P value | |
| Female | 1,538 (35.1) | 289 (36.9) | 0.34 | 204 (25.8) | 51 (32.3) | 0.09 |
| Age (years) | 63.2 ± 6.5 | 61.6 ± 6.4 | <0.0001 | 63.33 ± 8.47 | 62.09 ± 9.29 | 0.10 |
| T2D duration (years) | 10.9 ± 7.5 | 9.1 ± 6.9 | <0.0001 | 10.5 ± 8.38 | 9.06 ± 8.71 | 0.05 |
| BMI (kg/m2) | 33.2 ± 5.2 | 31.9 ± 4.8 | <0.0001 | 31.8 ± 5.41 | 32.33 ± 5.97 | 0.27 |
| Waist circumference (cm) | 110.0 ± 12.9 | 105.3 ± 12.0 | <0.0001 | 108.99 ± 13.08 | 108.42 ± 13.97 | 0.62 |
| Height (cm) | 171.7 ± 9.5 | 170.0 ± 9.4 | <0.0001 | NA | NA | NA |
| HbA1c (%) | 8.22 ± 0.93 | 8.11 ± 0.90 | 0.02 | 7.54 ± 1.54 | 7.66 ± 1.63 | 0.40 |
| Fasting glucose (mmol/L) | 9.93 ± 2.82 | 9.75 ± 2.76 | 0.09 | NA | NA | NA |
| SBP (mmHg) | 135.2 ± 16.7 | 134.7 ± 16.4 | 0.42 | 131.65 ± 20.6 | 128.75 ± 16.32 | 0.05 |
| DBP (mmHg) | 74.1 ± 10.4 | 75.0 ± 10.7 | 0.03 | 73.82 ± 11.92 | 73.54 ± 11.22 | 0.78 |
| LDL (mmol/L) | 2.67 ± 0.84 | 2.68 ± 0.83 | 0.52 | 2.43 ± 0.83 | 2.59 ± 0.85 | 0.03 |
| HDL (mmol/L) | 1.04 ± 0.27 | 1.06 ± 0.29 | 0.0047 | 0.95 ± 0.23 | 0.98 ± 0.23 | 0.13 |
| Women | 1.16 ± 0.29 | 1.22 ± 0.29 | 0.0009 | 1.06 ± 0.24 | 1.02 ± 0.22 | 0.19 |
| Men | 0.97 ± 0.23 | 0.98 ± 0.23 | 0.54 | 0.91 ± 0.21 | 0.96 ± 0.24 | 0.02 |
| Total cholesterol (mmol/L) | 4.74 ± 1.05 | 4.76 ± 1.04 | 0.33 | 4.35 ± 1.05 | 4.56 ± 1.16 | 0.03 |
| Triglycerides (mmol/L)† | 1.95 (1.37–2.81) | 1.91 (1.29–2.76) | 0.14 | 1.76 (1.24–2.58) | 1.90 (1.28–2.7) | 0.46 |
| eGFR (mL/min/1.73 m2) | 87.8 ± 21.7 | 90.4 ± 20.4 | 0.0016 | NA | NA | NA |
| UACR (mg/mmol)† | 1.4 (0.7–4.2) | 1.1 (0.6–2.8) | <0.0001 | NA | NA | NA |
| Previous CV event* | 1,556 (35.5) | 264 (33.7) | 0.33 | 318 (40.2) | 69 (43.7) | 0.42 |
| Report of retinopathy | 439 (11.3) | 40 (5.6) | <0.0001 | NA | NA | NA |
| Current smoker | 496 (11.3) | 84 (10.7) | 0.8 | 63 (8) | 19 (12.1) | 0.09 |
| Previous smoker | 2,194 (57.0) | 390 (56.2) | 0.8 | 456 (57.8) | 88 (56.1) | 0.69 |
| Insulin therapy | 1,598 (36.5) | 220 (28.1) | <0.0001 | 212 (26.8) | 27 (17.1) | 0.01 |
| ACCORD Glycemia trial | ||||||
| Standard | 2,227 (50.8) | 371 (47.3) | 0.07 | — | — | — |
| Intensive | 2,157 (49.2) | 413 (52.7) | — | — | — | |
| ACCORD BP trial | 1,862 (42.5) | 361 (46.1) | 0.06 | — | — | — |
| Standard | 926 (21.1) | 182 (23.2) | 0.81 | — | — | — |
| Intensive | 936 (21.4) | 179 (22.8) | — | — | — | |
| ACCORD Lipid trial | 2,522 (57.5) | 423 (54.0) | 0.06 | — | — | — |
| Fibrate | 1,294 (29.5) | 219 (27.9) | 0.86 | — | — | — |
| Placebo | 1,228 (28.0) | 204 (26.0) | — | — | — | |
| BARI 2D CV intervention | ||||||
| Medical therapy | — | — | — | 398 (50.3) | 67 (42.4) | 0.07 |
| Early revascularization | — | — | — | 393 (49.7) | 91 (57.6) | |
| BARI 2D diabetic therapy | ||||||
| Insulin provision | — | — | — | 394 (49.8) | 71 (44.9) | 0.26 |
| Insulin sensitization | — | — | — | 397 (50.2) | 87 (55.1) | |
Except where noted, data are means ± SD for continuous variables and counts (%) for categorical data. BP, blood pressure; CV, cardiovascular; DBP, diastolic blood pressure; NA, not available; SBP, systolic blood pressure.
†Median (interquartile range). *Prior CV event: In ACCORD, this includes secondary prevention status or history of myocardial infarction, stroke, angina, and/or ischemic changes (electrocardiogram) on graded exercise tolerance test or positive imaging, coronary revascularization procedures, or other revascularization procedures at baseline; in BARI 2D, this includes history of myocardial infarction, congestive heart failure, stroke, or transient ischemic attack.