Department of Neurology, Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, Philadelphia, PA, USA.
UCB Pharma, Brussels, Belgium.
Epilepsia. 2020 Dec;61(12):2696-2704. doi: 10.1111/epi.16745. Epub 2020 Nov 17.
The effects of anticonvulsants on lipids are the subject of considerable concern and investigation, but there are almost no data on this issue from randomized trials. We evaluated serum lipid profiles in adults with newly diagnosed epilepsy, following randomization to lacosamide (LCM) or carbamazepine (CBZ) monotherapy.
We analyzed data from a Phase 3, international, randomized, double-blind trial of LCM vs CBZ for the initial treatment of focal epilepsy. Serum lipid profiles in patients not taking lipid-lowering agents and providing blood samples under fasting conditions before treatment, and following 3 or 12 months of treatment with LCM or CBZ at various doses were analyzed.
At 12 months, 271 patients satisfied the inclusion criteria for the analysis. No change was observed in LCM-treated patients for total cholesterol, cholesterol fractions, or triglycerides. CBZ-treated patients showed an increase of 21.1 mg/dL in total cholesterol, 12.6 mg/dL in low-density lipoprotein (LDL) cholesterol, 12.5 mg/dL in non-high density lipoprotein (non-HDL) cholesterol, and 8.5 mg/dL in HDL cholesterol; triglycerides remained unchanged. The proportion of patients with elevated total cholesterol levels (above the upper limit of the reference range) did not change in the LCM treatment group (37.0% at Baseline; 34.8% at 12 months), but increased from 30.8% (at Baseline) to 49.6% (at 12 months) in the CBZ treatment group.
This study provides Class II evidence that CBZ elevates serum lipids, whereas LCM has no effect on lipids. It supports LCM as an appropriate choice for new-onset focal epilepsy.
抗惊厥药对血脂的影响是人们关注和研究的一个重要课题，但随机试验几乎没有关于这个问题的数据。我们评估了新诊断为癫痫的成年人在随机分组接受拉科酰胺（LCM）或卡马西平（CBZ）单药治疗后的血脂谱。
我们分析了一项 LCM 与 CBZ 治疗局灶性癫痫初始治疗的 3 期国际随机双盲试验的数据。在未服用降脂药物且治疗前空腹采血的患者中，分析了在不同剂量下接受 LCM 或 CBZ 治疗 3 或 12 个月后的血清脂谱。
在 12 个月时，271 名患者符合分析纳入标准。LCM 治疗组的总胆固醇、胆固醇各组分或甘油三酯均无变化。CBZ 治疗组总胆固醇升高 21.1mg/dL，低密度脂蛋白（LDL）胆固醇升高 12.6mg/dL，非高密度脂蛋白（non-HDL）胆固醇升高 12.5mg/dL，高密度脂蛋白（HDL）胆固醇升高 8.5mg/dL；甘油三酯保持不变。LCM 治疗组总胆固醇水平升高（高于参考范围上限）的患者比例无变化（基线时为 37.0%，12 个月时为 34.8%），但 CBZ 治疗组从基线时的 30.8%增加到 12 个月时的 49.6%。
本研究提供了 II 级证据，表明 CBZ 升高血清脂质，而 LCM 对脂质没有影响。它支持 LCM 作为新诊断的局灶性癫痫的适当选择。
