Trial reportEpilepsia2020
Effects of lacosamide and carbamazepine on lipids in a randomized trial.
Trial report in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01243177 (A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.The Cochrane database of systematic reviews · 2022Pooled it
- Safety and tolerability of short-term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open-label, phase 2/3 trial.Epilepsia open · 2023Trial
- Trial
- The therapeutic effects of ketogenic diet, lacosamide, and combination therapy in children with refractory epilepsy.BMC pediatrics · 2025Article
- Cardiovascular Effects of Antiseizure Medications for Epilepsy.CNS drugs · 2025Review
- Antiseizure medications and their differing effects on cardiovascular risk.Epilepsy & behavior reports · 2025Review
- Serum HDL-C levels in children with epilepsy: a single-center retrospective study.Frontiers in nutrition · 2025Article
- Integrating metabolomics and lipidomics revealed a decrease in plasma fatty acids but an increase in triglycerides in children with drug-refractory epilepsy.Epilepsia open · 2023Article
- Zonisamide Therapy Reduces Metabolic Consequences and Diminishes Nonalcoholic Fatty Liver Disease in Patients with Epilepsy.Journal of clinical medicine · 2021Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
objectiveThe 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.
methodsWe 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.
resultsAt 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. SIGNIFICANCE: 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.