Eslicarbazepine acetate a suitable treatment option for epilepsy
Once-daily eslicarbazepine acetate (ESL) is as effective as twice-daily controlled-release carbamazepine (CBZ-CR) in the first-line treatment of adults with newly diagnosed epilepsy and focal onset seizures, according to the results of a phase III trial.
“Our findings suggest that eslicarbazepine acetate is a suitable treatment option for patients with newly diagnosed epilepsy with the advantage of having a QD formulation,” the authors said.
In the trial, a total of 813 adult patients were randomized to receive either ESL at 800 mg (n=401) or CBZ-CR at 200 mg (n=412). Those who remained seizure-free for the 26-week evaluation period entered a 6-month maintenance period. If a seizure occurred during the evaluation period, patients were titrated to the next target dose level (level B: ESL, 1200 mg; CBZ-CR, 400 mg). Doses were further escalated to the next level (level C: ESL, 1600 mg; CBZ-CR, 600 mg) if a seizure occurred in the level B evaluation period.
Majority of patients remained on treatment at dose level A, with 67.6 percent in the ESL arm and 76.9 percent in the CBZ-CR arm. The respective proportions of patients who were treated at dose levels B and C were 17.5 and 15.0 percent in the ESL arm and 14.8 and 8.3 percent in the CBZ-CR arm.
Of note, more than 70 percent of patients in each treatment group met the primary endpoint of remaining free of seizure for ≥6 months at the last evaluated dose, with ESL demonstrating noninferiority (71.1 percent vs 75.6 percent with CBZ-CR; average risk difference, −4.28 percent; relative risk difference, −5.87 percent). [Epilepsia 2018;doi:10.1111/epi.13993]
Rates of treatment-emergent adverse events (TEAEs) were also comparable, with 76.3 percent of patients in ESL arm and 79.6 percent in the CBZ-CR arm experiencing at least one TEAE. Most of such events were of mild intensity, with the most common being dizziness, headache, somnolence, fatigue, nausea and increased γ-glutamyl transferase.
“Although rates of AEs were similar between the two treatment groups, it is notable that fewer patients discontinued ESL (14.0 percent) compared with CBZ-CR (18.4 percent), and that this difference was primarily driven by lower rates of discontinuation due to AEs,” the authors noted.
“Poor treatment adherence to medication is well known to be a major barrier to sustained remission and functional restoration. Because most studies to date have shown equivalent efficacy of available antiepileptic drugs, practical features such as good tolerability, a low potential for drug interactions, and ease of dosing are important drivers of medication choice,” they explained.
The authors additionally pointed out that the QD dosing regimen of ESL was of practical relevance, as recent real-world studies showed that nonadherence to antiepileptic drugs was significantly more common with BID dosing vs QD dosing. [Neurology 2016;87:466-472]