Table 2.
Efficacy Data, Escape, and Discontinuation
| LTG XR 300 | LTG XR 250 | |
|---|---|---|
| (300 mg/day) | (250 mg/day) | |
| Investigator-reported endpoints | ||
| % of patients who prematurely discontinued the study | ||
| n (%) | 11/93 (12) | 13/81 (16) |
| % of patients who met escape criteria* | ||
| n (%) | 4/93 (4) | 5/81 (6) |
| Calculated endpoints | ||
| % of patients who met escape criteria, study per protocol analysis | ||
| n (%) | 25/93 (27) | 24/81 (30) |
| [95% CI] | [17.9, 35.9]† | [19.7, 39.6]† |
| % of patients who met escape criteria, historical control analysis | ||
| n (%) | 31/108 (29) | 33/97 (34) |
| [95% CI] | [20.2, 37.2]† | [24.6, 43.4]† |
| % of patients who prematurely discontinued the study, study per-protocol analysis | ||
| n (%) | 31/93 (33) | 29/81 (36) |
| [95% CI] | [23.8, 42.9]† | [25.4, 46.2]† |
*Statistical comparison of this parameter was not a planned analysis
†95% confidence intervals (CIs) falling below 65.3% escapes reflect a difference from the historical controls
LTG XR = lamotrigine extended-release tablets