Lacosamide vs Controlled-Release Carbamazepine Monotherapy as Initial Epilepsy Treatment


Lacosamide vs Controlled-Release Carbamazepine Monotherapy as Initial Epilepsy Treatment

Information sourced from NEJM Journal Watch:

Lacosamide vs. Controlled-Release Carbamazepine Monotherapy as Initial Epilepsy Treatment

Lacosamide was no less effective for new-onset seizures in patients with clinically suspected partial epilepsy.

Nearly all new antiepilepsy medications (AEDs) obtain initial indications as adjunctive (add-on) therapy in patients with medically uncontrolled epilepsy, yet most patients are treated (or wish to be) with only one medicine. Very few head-to-head comparisons have been done between new AEDs and older medications with established efficacy in the largest generalizable populations: those with new-onset seizures or those that can be controlled with one AED. Lacosamide (LCM) is FDA-approved as monotherapy based on historical controls and is not approved as monotherapy in Europe. This large international, double-blind, randomized, manufacturer-sponsored study compared efficacy and adverse effects of LCM versus [those of] controlled-release carbamazepine (CBZ-CR) as initial treatment for new-onset suspected partial epilepsy. Reflecting typical medication management, flexible stepwise dose increments were based on seizure control and tolerability.

LCM was noninferior to CBZ-CR in the proportion of patients seizure-free after 6 months of treatment at the last assessed dose (74% with LCM and 70% with CBZ-CR). LCM and CBZ-CR treatment also did not differ on efficacy measures for predefined subgroups: patients with definite partial epilepsy, patients with generalized tonic-clonic seizures without definite evidence of focal onset, and patients aged ≥65 years. Incidence of treatment-emergent adverse events was similar; however, for drug-related adverse events, LCM had fewer events than CBZ-CR (37% vs. 46%). Fewer LCM recipients discontinued because of adverse events.


This important study provides strong evidence for another good choice in the initial treatment of new-onset seizure disorders other than generalized epilepsy. One study strength was the flexible-dose design reflecting typical practice more than the fixed doses and fixed titration schedules used in most AED studies. Although this was a noninferiority trial, all efficacy measures were essentially equivalent and the incidence of most adverse event types favored LCM. Retail cost of LCM is more than four times that of CBZ-CR ( The clinical significance of many adverse events (e.g., elevated liver function tests) remains to be determined.

Robert C. Knowlton, MD, MSPH reviewing Baulac M et al. Lancet Neurol 2017 Jan.


Baulac M et al. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: A phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol 2017 Jan; 16:43.
[PubMed® abstract]

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