Table 1.
Baseline characteristics of patients at randomization
|
All patients n = 38 |
Leucovorin 15 mg, n = 19 | Leucovorin 25 mg, n = 19 | p-value | |
|---|---|---|---|---|
| Age, years, mean ± SD | 53.6 ± 14.2 | 51.4 ± 16.7 | 55.7 ± 11.2 | 0.4 |
| Gender, female: male | 24:14 | 12:7 | 12:7 | 1.0 |
| Underlying Disease, n (%) | ||||
| Rheumatoid arthritis | 25 (66) | 11 (58) | 14 (74) | 0.21 |
| Psoriasis vulgaris | 8 (21) | 4 (21) | 4 (21) | |
| Other diseases | 5 (13) | 4 (21) | 1 (5) | |
| Duration of diseasea, years | 6.5 (4–10) | 6.5 (2.5–10) | 6.5 (4.3–11.5) | 0.71 |
| Comorbid HT or DM, n (%) | 11 (29) | 6 (32) | 5 (26) | 0.72 |
| Cause of Toxicity | ||||
| Erroneous overdoseb | 26 (68) | 13 (68) | 13 (68) | 1.0 |
| Cumulative dose of MTX taken erroneously, mgd | 75 (50–100) | 50 (45–87.5) | 95 (69–126) | 0.04 |
| Pre-existing renal failure, n (%)c | 14 (37) | 7 (37) | 7 (37) | 1.0 |
| Unknown cause of toxicity, n (%) | 5 (13) | 2 (11) | 3 (16) | 0.9 |
| Baseline investigations | ||||
| Hemoglobin, g/dl | 8.4 (7.3–9.3) | 8.4 (7.3–9.1) | 8.7 (7.2–9.5) | 0.73 |
| White blood count (× 10^9/L) | 0.8 (0.4–1.8) | 0.8 (0.3–1.8) | 0.8 (0.4–1.8) | 0.66 |
| Platelet count (× 10^9/L) | 23.5 (9–77.3) | 17 (9–56) | 45 (9–78) | 0.49 |
| Serum Creatinine, mg/dl | 1.5 (0.9–2.4) | 1.6 (0.9–2.2) | 1.4 (1–2.7) | 0.89 |
| AST, IU/L | 33 (18–66) | 28 (12–52) | 37 (30–89) | 0.04 |
| ALT, IU/L | 41 (17–83) | 28 (16–69) | 46 (18–86) | 0.45 |
| Serum albumin, g/dl | 2.7 (2.2–3.2) | 2.5 (2.1–3.1) | 3.1 (2.5–3.5) | 0.045 |
All values are in median (IQR) unless specified
Abbreviations AST Aspartate aminotransferase, ALT Alanine aminotransferase, HT Hypertension, DM Diabetes mellitus, MTX Methotrexate
Normal ranges: white blood count (× 10^9/L) is 4–11, platelet (× 10^9/L) is 150–450, serum creatinine 0.5–1.3 mg/dl, AST and ALT is ≤ 40 IU/L, serum albumin is 3.5–5.5 g/dl
aFor underlying disease of rheumatoid arthritis or psoriasis
bMethotrexate taken daily or on alternate days
c7 patients had both renal failure and overdose (3 in 15 mg group and 4 in 25 mg group)
dThe cumulative dose of methotrexate was available in 25 patients