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 (https://www.healthwarehouse.com). 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.
NEJM Journal Watch is produced by NEJM Group, a division of the Massachusetts Medical Society. Copyright ©2017 Massachusetts Medical Society. All rights reserved.
The above message comes from NEJM Journal Watch, who is solely responsible for its content.
You have received this email because you requested follow-up information to an Epocrates DocAlert® message. For more information about Epocrates, please click here.
For questions, feedback, or suggestions regarding Epocrates DocAlert® messages, please contact the Medical Information Team at email@example.com.