Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historical-control phase III study

Table 3 Demographic and clinical characteristics of the ITT population ^*

Characteristic	ESL 1200 mg	ESL 1600 mg	Total
Characteristic	(n = 58)	(n = 114)	(n = 172)
Age, years; median (range)	37.0 (16–60)	35.5 (16–65)	36.5 (16–65)
Gender, male; n (%)	31 (53.4)	52 (45.6)	83 (48.3)
Race; n (%)
White	53 (91.4)	107 (93.9)	160 (93.0)
Black or African American	5 (8.6)	1 (0.9)	6 (3.5)
Other	0	6 (5.3)	6 (3.5)
Region; n (%)
US	15 (25.9)	28 (24.6)	43 (25.0)
Non-US	43 (74.1)	86 (75.4)	129 (75.0)
BMI, kg/m²; median (range)	25.6 (17–59)	24.3 (17–51)	24.7 (17–59)
Maximum consecutive 2-day baseline seizure rate
Mean ± SD	2.2 ± 1.84	2.5 ± 1.46	2.4 ± 1.60
Maximum consecutive 28-day baseline seizure rate
Mean ± SD	9.2 ± 6.72	11.1 ± 7.94	10.5 ± 7.59
Baseline AEDs used by ≥20% patients^†; n (%)
Carbamazepine	22 (37.9)	27 (23.7)	49 (28.5)
Valproic acid^‡	12 (20.7)	39 (34.2)	51 (29.7)
Number of AEDs at baseline^†; n (%)
1	41 (70.7)	70 (61.4)	111 (64.5)
2	17 (29.3)	44 (38.6)	61 (35.5)

^*At entry to the baseline period.
^†An AED was considered to be used at baseline if it was started at any time prior to first dose of study drug and continued into the titration period.
^‡Includes all forms of valproic acid (ergenyl chrono, valproate semisodium, valproate sodium and valproic acid).
Note: Percentages are calculated based on the number of patients with non-missing data in the ITT population in each column.
ITT = intention-to-treat; ESL = eslicarbazepine acetate; US = United States; BMI = body mass index; SD = standard deviation; AED = antiepileptic drug.

ISSN: 1471-2377