TABLE 2.
characteristics of patients, efficacy, and tolerance according to the indication of cannabidiol.
| Clinical variable |
Authorized n = 32 |
Off‐label n = 59 |
p value |
|---|---|---|---|
| Sex (female) | 10 (31.3%) | 32 (54.2%) | 0.06 |
| Age (mean and standard deviation) | 29.5 (7.57) | 31.3 (10.1) | 0.36 |
| Number of concomitant antiseizure medications (median and range) | 3 (0–7) | 3 (1–6) | 0.43 |
| Active vagus nerve stimulator | 9 (28.1%) | 21 (35.6%) | 0.70 |
| Clobazam co‐prescription | 16 (51.6%) | 26 (44.1%) | 0.75 |
| Treatment duration of CBD (months) (median and interquartile range) | 27 (20–34) | 24 (18.5–27.5) | 0.11 |
| Maximal treatment dose (mg/kg/day) (median and interquartile range) | 10.7 (8.63–12.4) | 11.1 (8.92–14.1) | 0.35 |
| Effectiveness | |||
| >50% reduction of seizure frequency | 10 (31.3%) | 21 (35.6%) | 0.85 |
| Less “intense” seizures | 3 (9.4%) | 10 (16.9%) | 0.53 |
| Shorter seizures | 3 (9.4%) | 5 (8.5%) | 1 |
| Cognitive‐behavioral improvement | 11 (34.4%) | 17 (28.8%) | 0.76 |
| Side‐effects | |||
| All | 20 (62.5%) | 24 (40.7%) | 0.08 |
| Sleepiness | 16 (50.0%) | 13 (22.0%) | 0.01* |
| Behavioral disorders | 2 (6.3%) | 5 (8.5%) | 1 |
| Increased seizures | 2 (6.3%) | 5 (8.5%) | 1 |
| Liver balance disturbance a | 2 (6.3%) | 1 (1.7%) | 0.28 |
| Other side effects | 1 (3.1%) | 4 (6.8%) | 0.65 |
a
“Liver balance disturbances” refers to an elevation in liver transaminase levels or bilirubin levels. * p < 0.05.