Table 1:
Baseline Characteristics of Randomized and Non-Randomized Populations in CIRT Trial
| Randomized population | Non-randomized population* (n = 1,372) | ||
|---|---|---|---|
| Low dose methotrexate (n = 2,391) | Placebo (n = 2,395) | ||
| Median (IQR) or n (%) unless noted | |||
| Female sex | 461 (19.3) | 437 (18.2) | 321 (23.4) |
| Age, (age at enrollment date) | 65.5 (59.5, 71.6) | 65.9 (59.7, 71.6) | 65.6 (58.6, 72.0) |
| Race | |||
| White | 2008 (84.0) | 2059 (86.0) | 1118 (81.5) |
| Black or African American | 194 (8.1) | 156 (6.5) | 135 (9.8) |
| Asian | 89 (3.7) | 92 (3.8) | 54 (3.9) |
| American Indian or Alaska Native | 6 (0.25) | 7 (0.29) | 4 (0.29) |
| Native Hawaiian or other Pacific Islander | 4 (0.17) | 6 (0.25) | 5 (0.36) |
| Multiple | 15 (0.6) | 9 (0.38) | 8 (0.58) |
| Other | 75 (3.1) | 66 (2.8) | 48 (3.5) |
| Diabetes | 1620 (67.8) | 1615 (67.4) | 957 (69.8) |
| Metabolic syndrome | 1603 (67.0) | 1572 (65.6) | 900 (65.6) |
| Hyperlipidemia | 2053 (85.9) | 2050 (85.6) | 962 (70.1) |
| Hypertension | 2153 (90.0) | 2169 (90.6) | … |
| Current cigarette use | 267 (11.2) | 270 (11.3) | … |
| Alcohol use | |||
| Rarely or never | 1487 (62.2) | 1473 (61.50) | … |
| ≤ 1 drink/week | 514 (21.5) | 520 (21.71) | … |
| >1 drink/week | 390 (16.3) | 402 (16.8) | … |
| eGFR, ml/min/1.73m2 | 81.2 (67.8, 95.3) | 80.9 (66.4, 95.5) | … |
| Body mass index, kg/m2 | 31.6 (28.1, 35.7) | 31.3 (28.0, 35.5) | 31.2 (27.8, 35.3) |
| Weekly study drug dosage (mean, SD)** | 14.9 (4.5) | 15.3 (4.3) | - |
| Statin use | 2062 (86.2) | 2052 (85.7) | 976 (71.1) |
| Aspirin use | 1861 (77.8) | 1807 (75.4) | 875 (63.8) |
| Insulin use | 515 (21.5) | 535 (22.3) | 297 (21.7) |
| Oral corticosteroid use | 27 (1.1) | 22 (0.9) | 7 (0.5) |
| Respiratory medication use ǂ | 273 (11.4) | 291 (12.2) | 164 (12.0) |
| Non-corticosteroid inhalers | 186 (7.8) | 212 (8.9) | 120 (8.8) |
| Corticosteroid inhalers | 42 (1.8) | 55 (2.3) | 22 (1.6) |
| Combination inhaler | 136 (5.7) | 135 (5.6) | 88 (6.4) |
| Oral and intravenous medications | 48 (2.0) | 54 (2.3) | 19 (1.4) |
| SF36 General Health | 60 (45, 75) | 60 (45, 75) | 55 (35, 70) |
| CES-D 10 | 5 (2, 9) | 5 (2, 8) | 6 (3, 10) |
Abbreviations: eGFR, estimated glomerular filtration rate; SF36, short-form 36; CES-D 10, Center for Epidemiologic Studies – Depression Scale, 10-item version.
Includes subjects that took a dosage of open-label methotrexate during the pre-randomization run-in phase but was not ultimately randomized. The ellipsis (…) signifies that over 90% of that variable was missing for non-randomized subjects since these were primarily collected at the time of randomization.
Mean weekly dosage refers to the post-randomization period.
Respiratory medications include non-corticosteroid, corticosteroid and combination inhalers, as well as oral and intravenous medications used for respiratory conditions.