Table 1. A summary of the patient characteristics.
| Patient Characteristics | PK analysis (N = 237) | PK-PD analysis (N = 169) | |
| N (%) or mean ± SD (range) | N (%) or mean ± SD (range) | ||
| Body weight [kg] | 48.8±20.9 (9.6–120.5) | 51.0±20.1 (13.0–120.5) | |
| Age [years] | 17.2±8.3 (2.2–52.2) | 18.0±7.8 (3.0–52.2) | |
| Gender (men/women) | 137 (57.8%)/100 (42.2%) | 102 (60.4%)/67 (39.6%) | |
| VPA dose [mg/day] | 934.3±540.2 (100–2600) | 903.8±502.7 (100–2600) | |
| VPA concentration [µg/mL] | 68.15±26.54 (7.70–165.0) | 67.8±25.7 (7.7–143.0) | |
| Seizure locus | |||
| Generalize | 111 (46.8%) | 75 (44.4%) | |
| Partial | 119 (50.2%) | 87 (51.5%) | |
| Unidentified | 7 (3.0%) | 7 (4.1%) | |
| Seizure type | |||
| Idiopathic | 64 (27.0%) | 42 (24.8%) | |
| Symptomatic | 75 (31.7%) | 50 (29.6%) | |
| Cryptogenic | 98 (41.3%) | 77 (45.6%) | |
| γ-GT [IU/L] | 51.3±68.6 (7–515) | 48.3±65.1 (2.4–515) | |
| ALT [IU/L] | 19.1±15.7(5–134) | 18.8±15.1 (4–134) | |
| AST [IU/L] | 23.0±10.2 (9–103) | 23.4±9.9 (9–103) | |
| Creatinine [mg/dL] | 0.5±0.2 (0.1–1.5) | 0.6±0.2 (0.1–1.5) | |
| BUN [mg/dL] | 12.7±3.7 (3.5–28.3) | 13.0±3.7 (3.5–28.3) | |
| Intellectual disability | 131 (55.3%) | 97 (57.4%) | |
| Monotherapy | 378 (45.7%) | 226 (47.8%) | |
| Co-administration | |||
| CBZ | 190 (23.0%) | 94 (19.9%) | |
| CLB | 128 (15.5%) | 90 (19.0%) | |
| GBP | 8 (1.0%) | 5 (1.1%) | |
| PB | 73 (8.8%) | 28 (5.9%) | |
| PHT | 88 (10.6%) | 45 (9.5%) | |
| TPM | 44 (5.3%) | 29 (6.1%) | |
| ZNS | 59 (7.1%) | 27 (5.7%) | |
PK = pharmacokinetic; PD = pharmacodynamic; N = number; SD = standard deviation; VPA = valproic acid; γ-GT: γ-glutamyltransferase; ALT: alanine aminotransferase; AST: aspartate aminotransferase; BUN = blood urea nitrogen; CBZ = carbamazepine; CLB = clobazam; GBP = gabapentine; PB = phenobarbital; PHT = phenytoin; TPM = topiramate; ZNS = zonisamide.