Comparison of two doses of leucovorin in severe low-dose methotrexate toxicity – a randomized controlled trial

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 disease^a, 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 overdose^b	26 (68)	13 (68)	13 (68)	1.0
Cumulative dose of MTX taken erroneously, mg^d	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

ISSN: 1478-6362