Table 2.
Total cholesterol and LDL cholesterol at Baseline and 12 mo and change from Baseline to 12 mo (12‐mo population) in patients with baseline levels below or above the upper limit of the reference range
Treatment | n | Baseline, mean (SD) | 12‐mo treatment a , mean (SD) |
Analysis of covariance model b Change in lipid levels from Baseline at 12 mo |
|||
---|---|---|---|---|---|---|---|
n | LS mean (SE) | P‐value (treatment) | |||||
Total cholesterol below upper limit of the reference range at Baseline c | |||||||
LCM, mg/dL | 87 | 170.2 (23.3) | 173.6 (32.2) | 86 | 3.0 (2.6) | <.001 | |
CBZ, mg/dL | 92 | 162.6 (28.2) | 185.60 (32.8)*** | 92 | 23.5 (2.6) | ||
Total cholesterol above upper limit of the reference range at Baseline d | |||||||
LCM, mg/dL | 51 | 225.6 (21.5) | 214.9 (30.6)** | 51 | −9.3 (3.5) | <.001 | |
CBZ, mg/dL | 41 | 228.0 (20.2) | 243.7 (29.3)*** | 41 | 15.9 (3.9) | ||
LDL cholesterol below upper limit of the reference range at Baseline e | |||||||
LCM, mg/dL | 102 | 97.6 (20.8) | 98.4 (26.7) | 101 | 0.8 (2.0) | <.001 | |
CBZ, mg/dL | 105 | 90.2 (23.1) | 103.7 (27.8)*** | 105 | 13.5 (2.0) | ||
LDL cholesterol above upper limit of the reference range at Baseline f | |||||||
LCM, mg/dL | 36 | 146.4 (15.0) | 137.5 (24.3)* | 36 | −8.3 (3.9) | .003 | |
CBZ, mg/dL | 26 | 151.9 (13.9) | 161.1 (23.1) | 26 | 10.5 (4.6) |
Abbreviations: ANCOVA, analysis of covariance; CBZ, carbamazepine; LCM, lacosamide; LDL, low‐density lipoprotein; LS, least squares; SD, standard deviation; SE, standard error.
The 12‐mo lipid levels included lipid values collected at 364 d (plus a 30‐d window) of treatment during the Treatment period.
The ANCOVA model included treatment as a main effect and age, sex, body mass index, and Baseline lipid level as covariates.
Total cholesterol levels ≤200 mg/dL.
Total cholesterol levels >200 mg/dL.
LDL‐cholesterol levels ≤130 mg/dL.
LDL‐cholesterol levels >130 mg/dL. Within treatment group comparison 12‐mo vs Baseline; paired t test.
P < .05.
P < .01.
P < .001.