VANCOUVER -- A once-daily dose of the anti-epileptic drug eslicarbazepine (Aptiom) appeared to control newly diagnosed partial onset seizures and was non-inferior to twice-daily carbamazepine (Tegretol), researchers reported here.
At 6 months, 71% of the patients on eslicarbazepine were free of seizures compared with 76% of those on carbamazepine, well within the prespecified margin of 12% needed to declare the once-daily drug drug non-inferior to the twice-a-day agent, said, of Gothenburg University in Sweden, and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- A once-daily dose of anti-epileptic drug eslicarbazepine (Aptiom) was non-inferior to twice-daily carbamazepine (Tegretol) for control of newly diagnosed partial onset seizures, in a Phase III, randomized, double-blind clinical trial.
- Note that treatment with once-daily eslicarbazepine did not raise any new or unexpected safety issues.
The primary endpoint was freedom from seizures after 6 months in the per protocol population, they reported at the American Academy of Neurology (AAN) annual meeting.
Additionally, at 1 year, 65% of the patients on eslicarbazepine were seizure-free compared with 70% of those on carbamazepine, also within the bounds of non-inferiority, she said in her emerging science poster presentation that described the effectiveness of the drugs in a phase III, double-blind, randomized clinical trial.
Ben-Menachem and colleagues enrolled 815 patients who were newly diagnosed with partial onset seizures. She reported on the per protocol patients, 388 who were on eslicarbazepine and 397 on controlled-release carbamazepine.
Eslicarbazepine is FDA approved for the treatment of partial-onset seizures as monotherapy or adjunctive therapy. The drug is approved by the European Medicines Agency as adjunctive therapy of partial onset seizures in adults, and by Health Canada as adjunctive therapy of partial onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.
Adult patients were initiated on treatment with 800 mg of eslicarbazepine or 200 mg of carbamazepine, If a breakthrough seizure occurred, the dose was increased to 1,200 mg of eslicarbazepine or 400 mg of carbamazepine; if there was a seizure at that dose, the medication was increased to 1,600 mg of eslicarbazepine or 600 mg carbamazepine.
Treatment with once-daily eslicarbazepine did not raise any new or unexpected safety issues, researchers reported.
"Seizure control is crucial," Ben-Menachem said. "A once-a-day drug may help people stick to their medication schedule. Memory issues, fatigue, or a complicated medication schedule can all interfere with a person taking their seizure-control medications on a regular basis, so having a once-daily option for patients, especially when they are newly diagnosed and are still learning to manage the disease, may be beneficial."
"The hope is that these results may also give doctors more options to better tailor treatments for patients with epilepsy," she added.
But once-a-day dosing is not necessarily a slam dunk when compared with twice-daily dosing of epilepsy drugs, cautioned , of the University of California Los Angeles.
"There are generally very little differences among these anti-epilepsy agents," he told ľֱ.
While some people think that once-a-day dosing improves compliance, Engel, who was not involved in the study, suggested that once-daily dosing can be problematic if a patients misses a dose. In that case, there might not be any drug on board for a period of time. But in patients taking the drug twice a day, there may be less of a period where there is no drug in the system if a dose is missed, Engel said.
Disclosures
The trial was supported by BIAL-Portela & Cª S.A.
Ben-Menachem disclosed relevant relationships with Eisai, UCB, Electrocore, Astella, Bial, Ever Neuropharma, Biogen Idec, Medtronics, GL Pharma, GlaxoSmithKline, Boehringer, Suniovion, and Actavis. Co-authors disclosed relevant relationships with UCB, Novartis, Desitin, Eisai, and Bial-Portela & Cª S.A.
Engel disclosed no relevant relationships with industry.
Primary Source
American Academy of Neurology
Ben-Menachem E, et al "Efficacy of eslicarbazepine acetate versus controlled-release carbamazepine as monotherapy in patients with newly diagnosed partial-onset seizures" AAN 2016.