Eslicarbazepine acetate was effective when used as an add-on treatment for patients with drug-resistant focal epilepsy, according to the authors of a Cochrane review published in the Cochrane Database Systematic Reviews.
While most patients with epilepsy have a good prognosis, up to 30% of patients with epileptic seizures have drug-resistant epilepsy, which can affect their psychosocial, psychiatric, and medical status. Eslicarbazepine acetate, an anti-epileptic drug that blocks voltage-dependent sodium channels, is believed to reduce the frequency of seizures in these patients.
The aim of the current updated version of a Cochrane review originally published in 2011 was to determine the efficacy and tolerability of eslicarbazepine acetate in combination with other drugs in patients with drug-resistant focal epilepsy.
The updated review included studies published from the date of the previous search (November 2011) through December 6, 2016. It aimed to include randomized controlled trials (RCTs), double-blind trials, placebo-controlled trials, and parallel group or crossover trials of patients with drug-resistant focal epilepsy, defined as persistent seizures despite treatment with one or more anti-epileptic drugs.
The primary endpoints were a reduction in seizure frequency of 50% or more and the proportion of patients with complete seizure cessation from time of randomization to study completion. Secondary endpoints were treatment discontinuation, side effects, and drug interactions.
The review included 5 RCTs with 1799 participants aged 16 to 77 years. Of these 5 studies, 4 were included in the previous version of this review and 1 study was added to the analysis. The included studies had treatment durations of 12 to 14 weeks.
An intention-to-treat analysis, pooling all doses of eslicarbazepine acetate, showed that eslicarbazepine acetate-treated patients were significantly more likely to achieve a 50% or greater reduction in seizure frequency (relative risk [RR], 1.71; 95% CI, 1.42-2.05). Treatment effectiveness was higher with increasing doses, ranging from 22% in the patients receiving eslicarbazepine acetate 400 mg / day (RR 1.22; 95% CI, 0.80-1.85) to 66% in the group receiving 800 mg / Day (RR 1.66; 95% CI 1.34-2.07 to 92% in those treated with a daily dose of 1200 mg (RR, 1.92; 95% CI, 1st , 56-2.37).
The data also showed that treatment with eslicarbazepine acetate was significantly associated with seizure freedom (RR 2.90; 95% CI 1.49-5.68). While eslicarbazepine acetate at a daily dose of 400 mg was not significantly associated with seizure freedom, both the 800 mg dose (RR 3.42; 95% CI 1.38–8.46) and the 1200 mg dose were (RR 3.46; 95% CI 1.40-8.54) were associated with a seizure-free state.
Compared to placebo, patients treated with eslicarbazepine acetate appeared to be more likely to discontinue treatment due to side effects (total RR over each dose 2.66; 95% CI 1.42-4.96).
Dizziness (RR 2.81; 99% CI 1.86-4.27), nausea (RR 2.61; 99% CI 1.36-5.01), vomiting (RR 3.30; 99% CI 1, 34-8.13), drowsiness (RR 1.71; 99% CI 1.11 to 2.63, and diplopia (RR 4.14; 99% CI 1.74 to 9.84) occurred in the eslicarbazepine acetate-treated group significantly more often, especially at higher doses.
While there were no major potential biases in the review process, the researchers cited the shortage of children as a major limitation in the studies currently being evaluated.
“The poor quality evidence presented by this review shows that both ESL [eslicarbazepine acetate] 800 mg and 1200 mg once a day can significantly reduce the frequency of seizures in adults with refractory focal epilepsy in the short term, ”the researchers concluded.
Chang XC, Yuan H, Wang Y, Xu HQ, Hong WK, Zheng RY. Eslicarbazepine acetate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. Published online June 22, 2021. doi: 10.1002 / 14651858.CD008907.pub4