Table 1.
Baseline Characteristics of the Trial Participants.*
| Characteristic | Low-Dose Methotrexate (N = 2391) | Placebo (N = 2395) |
|---|---|---|
| Median age (IQR) — yr | 65.6 (59.7–71.8) | 66.0 (59.8–71.7) |
| Female sex — no. (%) | 461 (19.3) | 437 (18.2) |
| Country — no. (%) | ||
| Canada | 407 (17.0) | 404 (16.9) |
| United States | 1984 (83.0) | 1991 (83.1) |
| Nonwhite race or Hispanic ethnic group — no./total no. (%)† | 545/2346 (23.2) | 485/2322 (20.9) |
| Current smoker — no. (%) | 267 (11.2) | 270 (11.3) |
| Alcohol use — no. (%) | ||
| Rarely or never | 1487 (62.2) | 1473 (61.5) |
| ≤1 drink/wk | 514 (21.5) | 520 (21.7) |
| >1 drink/wk | 390 (16.3) | 402 (16.8) |
| Median body-mass index (IQR)‡ | 31.6 (28.2–35.5) | 31.3 (28.1–35.6) |
| Hypertension — no. (%) | 2153 (90.0) | 2169 (90.6) |
| Qualifying event — no. (%) | ||
| Myocardial infarction | 1451 (60.7) | 1458 (60.9) |
| Multivessel coronary disease | 940 (39.3) | 937 (39.1) |
| Qualifying coexisting condition — no. (%) | ||
| Diabetes | 788 (33.0) | 823 (34.4) |
| Metabolic syndrome | 771 (32.2) | 780 (32.6) |
| Diabetes and metabolic syndrome | 832 (34.8) | 792 (33.1) |
| History of congestive heart failure | 288 (12.0) | 332 (13.9) |
| History of percutaneous coronary intervention | 1396 (58.4) | 1420 (59.3) |
| History of coronaryartery bypass grafting | 1010 (42.2) | 1032 (43.1) |
| Family history of premature myocardial infarction — no./total no. (%)§ | 550/2118 (26.0) | 536/2116 (25.3) |
| Family history of premature stroke — no./total no. (%)§ | 142/2144 (6.6) | 136/2160 (6.3) |
| Use of ACE inhibitor or ARB — no. (%) | 1736 (72.6) | 1724 (72.0) |
| Use of statin — no. (%) | 2058 (86.1) | 2052 (85.7) |
| Use of beta-blocker — no. (%) | 1870 (78.2) | 1905 (79.5) |
| Use of antiplatelet or antithrombotic agent — no. (%) | 2082 (87.1) | 2054 (85.8) |
| Median lipid levels (IQR) — mg/dl | ||
| Total cholesterol | 141.0 (122.0–168.0) | 140.9 (122.0–164.0) |
| LDL cholesterol | 68.0 (54.0–87.0) | 68.0 (53.3–86.0) |
| HDL cholesterol | 41.0 (34.7–49.0) | 41.0 (35.0–48.0) |
| Triglycerides | 135.4 (98.0–191.2) | 136.0 (98.2–191.6) |
| Median high-sensitivity Creactive protein level (IQR) — mg/liter | 1.53 (0.78–3.59) | 1.50 (0.70–3.29) |
| Median interleukin-1β level (IQR) — pg/ml | 1.59 (0.49–3.17) | 1.46 (0.53–3.11) |
| Median interleukin-6 level (IQR) — pg/ml | 2.37 (1.53–3.76) | 2.30 (1.58–3.51) |
| Median glycated hemoglobin level (IQR) — % | 6.6 (6.0–7.5) | 6.5 (5.9–7.5) |
There were no significant differences between the groups in the characteristics at baseline (P<0.05). Data for lipid and inflammatory biomarkers as well as glycated hemoglobin are the values at enrollment, before the active-treatment run-in phase. Effects of the run-in phase on these and other variables are described in Table S1 in the Supplementary Appendix. 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. ACE denotes angiotensin-converting enzyme, ARB angiotensin-receptor blocker, HDL high-density lipoprotein, IQR interquartile range, and LDL low-density lipoprotein.
Race or ethnic group was reported by the patient.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
A family history of premature myocardial infarction or premature stroke was considered to be an event occurring in the mother before the age of 65 or in the father before the age of 55.