Table 1.
Baseline Characteristics of the Patients.*
| Characteristic | All Patients (N = 5518) |
Fenofibrate (N = 2765) |
Placebo (N = 2753) |
P Value |
|---|---|---|---|---|
| Age — yr | 62.3±6.8 | 62.2±6.7 | 62.3±6.9 | 0.69 |
| Female sex — no. (%) | 1694 (30.7) | 851 (30.8) | 843 (30.6) | 0.90 |
| Race or ethnic group — no. (%)† | ||||
| White | 3774 (68.4) | 1909 (69.0) | 1865 (67.7) | 0.30 |
| Black | 834 (15.1) | 392 (14.2) | 442 (16.1) | 0.05 |
| Hispanic | 407 (7.4) | 213 (7.7) | 194 (7.0) | 0.35 |
| Education — no. (%) | 0.19 | |||
| Less than high school | 750 (13.6) | 394 (14.2) | 356 (12.9) | |
| High-school graduate or GED | 1433 (26.0) | 712 (25.8) | 721 (26.2) | |
| Some college | 1827 (33.1) | 885 (32.0) | 942 (34.2) | |
| College degree or higher | 1505 (27.3) | 772 (27.9) | 733 (26.6) | |
| Missing data | 3 (<0.1) | 2 (0.1) | 1 (<0.1) | |
| Previous cardiovascular event — no. (%) | 2016 (36.5) | 1008 (36.5) | 1008 (36.6) | 0.90 |
| Previous congestive heart failure — no. (%) | 291 (5.3) | 151 (5.5) | 140 (5.1) | 0.54 |
| Cigarette-smoking status — no. (%) | 0.42 | |||
| Current | 803 (14.6) | 410 (14.8) | 393 (14.3) | |
| Former | 2546 (46.2) | 1292 (46.7) | 1254 (45.6) | |
| Never | 2161 (39.2) | 1059 (38.3) | 1102 (40.0) | |
| Missing data | 8 (0.1) | 4 (0.1) | 4 (0.1) | |
| Weight — kg | 94.8±18.7 | 94.5±18.5 | 95.2±18.8 | 0.21 |
| Body-mass index‡ | 32.3±5.4 | 32.2±5.4 | 32.4±5.4 | 0.32 |
| Blood pressure — mm Hg | ||||
| Systolic | 133.9±17.8 | 133.8±17.7 | 134.0±17.9 | 0.79 |
| Diastolic | 74.0±10.8 | 73.9±10.7 | 74.0±10.9 | 0.58 |
| Medications — no. (%) | ||||
| Insulin | 1836 (33.3) | 919 (33.2) | 917 (33.3) | 0.95 |
| Metformin | 3420 (62.0) | 1712 (61.9) | 1708 (62.0) | 0.92 |
| Any sulfonylurea | 2892 (52.4) | 1440 (52.1) | 1452 (52.7) | 0.62 |
| Any thiazolidinedione | 973 (17.6) | 480 (17.4) | 493 (17.9) | 0.59 |
| Angiotensin-converting–enzyme inhibitor | 2967 (53.8) | 1473 (53.3) | 1494 (54.3) | 0.46 |
| Angiotensin-receptor blocker | 838 (15.2) | 405 (14.6) | 433 (15.7) | 0.26 |
| Aspirin | 3106 (56.3) | 1583 (57.3) | 1523 (55.3) | 0.15 |
| Beta-blocker | 1798 (32.6) | 912 (33.0) | 886 (32.2) | 0.53 |
| Any thiazide diuretic | 1473 (26.7) | 740 (26.8) | 733 (26.6) | 0.91 |
| Statin | 3299 (59.8) | 1641 (59.3) | 1658 (60.2) | 0.51 |
| Any lipid-lowering agent | 3558 (64.5) | 1773 (64.1) | 1785 (64.8) | 0.58 |
| Duration of diabetes — yr | ||||
| Median | 9 | 10 | 9 | 0.83 |
| Interquartile range | 5–15 | 5–15 | 5–15 | |
| Glycated hemoglobin — % | ||||
| Mean | 8.3±1.0 | 8.3±1.0 | 8.3±1.0 | 0.52 |
| Median | 8.1 | 8.1 | 8.1 | |
| Interquartile range | 7.6–8.8 | 7.6–8.8 | 7.5–8.8 | |
| Fasting plasma glucose — mg/dl | 175.8±54.9 | 176.5±54.5 | 175.1±55.3 | 0.38 |
| Amputation due to diabetes — no. (%) | 110 (2.0) | 59 (2.1) | 51 (1.9) | 0.45 |
| Potassium — mg/dl | 4.5±0.4 | 4.5±0.4 | 4.5±0.4 | 0.31 |
| Serum creatinine — mg/dl | 0.9±0.2 | 0.9±0.2 | 0.9±0.2 | 0.96 |
| Estimated glomerular filtration rate — no. (%) | ||||
| 30–49 ml/min/1.73 m2 | 141 (2.6) | 71 (2.6) | 70 (2.5) | 0.89 |
| >50 ml/min/1.73 m2 | 5347 (97.4) | 2668 (97.4) | 2679 (97.5) | |
| Plasma cholesterol — mg/dl | ||||
| Total | 175.2±37.3 | 174.7±36.8 | 175.7±37.9 | 0.36 |
| Low-density lipoprotein | 100.6±30.7 | 100.0±30.3 | 101.1±31.0 | 0.15 |
| High-density lipoprotein | 38.1±7.8 | 38.0±7.8 | 38.2±7.8 | 0.25 |
| Plasma triglyceride — mg/dl | ||||
| Median | 162 | 164 | 160 | 0.15 |
| Interquartile range | 113–229 | 114–232 | 112–227 | |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. To convert the values for glucose to millimoles per liter, multiply by 0.055551. To convert the values for cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for triglycerides to millimoles per liter, multiply by 0.01129. To convert the values for potassium to millimoles per liter, multiply by 0.2558. To convert the values for creatinine to micromoles per liter, multiply by 88.4. GED denotes general equivalency diploma.
Race or ethnic group was self-reported, and patients could check multiple categories.
The body-mass index is the weight in kilograms divided by the square of the height in meters.