Lipid Levels During Lacosamide and Controlled-release Carbamazepine Monotherapy: Post-hoc Analysis of a Prospective Randomized Double-blind Trial
Abstract number :
1.284
Submission category :
7. Antiepileptic Drugs / 7B. Clinical Trials
Year :
2017
Submission ID :
342571
Source :
www.aesnet.org
Presentation date :
12/2/2017 5:02:24 PM
Published date :
Nov 20, 2017, 11:02 AM
Authors :
Svetlana Dimova, UCB Pharma, Brussels, Belgium; Ying Zhang, UCB Pharma, Raleigh, NC, USA; Björn Steiniger-Brach, UCB Pharma, Brussels, Belgium; Marc De Backer, UCB Pharma, Brussels, Belgium; Robert Roebling, UCB Pharma, Monheim am Rhein, Germany; Daya Che
Rationale: Evidence suggests that carbamazepine (CBZ) and other enzyme-inducing AEDs could increase serum lipid levels. A small trial in young male patients with focal seizures showed favorable changes in the lipid profile when switched from CBZ to lacosamide (LCM), as adjunctive treatment to levetiracetam (Elger CE et al. Epilepsy Behav. 2016;62:1-5). The objective of this post-hoc analysis was to evaluate the serum lipid profile after 12 months of LCM or controlled-released CBZ (CBZ-CR) monotherapy in adults with newly diagnosed epilepsy. Methods: Patients with newly diagnosed epilepsy enrolled in the double-blind non-inferiority monotherapy trial (SP0993; NCT01243177; assessing efficacy and tolerability of LCM vs CBZ-CR), who did not take lipid lowering agents and who had provided blood samples under fasted conditions at baseline and at 12 months after treatment initiation were included in this post-hoc analysis. LCM (initiated 100mg/day) and CBZ-CR (initiated 200mg/day) were titrated to an initial target dose of 200mg/day or 400mg/day, respectively. Depending on seizure control, doses could be further increased (400 or 600mg/day LCM, 800 or 1200mg/day CBZ-CR). Serum levels of total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides (TGs) were assessed at baseline and at 12 months. The actual change (unadjusted) from baseline to 12 months was calculated and the change was analyzed using an analysis of covariance (ANCOVA) model including treatment as a main effect and age, gender and BMI as covariates. Results: Of the 886 patients that received trial medication, 277 (139 LCM; 138 CBZ-CR) were included in this analysis (mean age 39.6 years; 59.6% male; mean BMI 24.6 kg/m2). 62.5% were 2 (56.8% LCM; 55.8% CBZ-CR). The proportion of female patients was slightly higher in the LCM subgroup (43.2%; CBZ-CR 37.7%). 12 months after treatment initiation, the majority of patients were on the initial lowest target dose (93.5% LCM 200mg/day; 90.6% CBZ-CR 400mg/day). Mean lipid levels at baseline were generally similar between the treatments with slightly higher levels for TC and LDL in the LCM subgroup and TGs in the CBZ-CR subgroup (Table 1). The use of CBZ-CR for 12 months was associated with an increase in mean levels of TC, LDL and HDL and no change in TGs. LCM treatment did not appear to have had an effect on mean TC, LDL, HDL and TGs levels (Table 1; Figure 1). The ANCOVA model for change in lipid levels from baseline to 12 months indicated significant difference between LCM and CBZ-CR for change in TC, LDL and HDL levels (Table 1). Conclusions: The results of this post-hoc analysis confirmed previous findings on the increase of lipid levels during CBZ treatment and showed no effect of 12-month LCM monotherapy on the lipid profile, suggesting LCM is a suitable long-term monotherapy option for adults with focal seizures. Funding: UCB Pharma-sponsored.
Antiepileptic Drugs