Analysis of clinical trials and a retrospective analysis of insurance claims data related to patients with epilepsy using eslicarbazepine acetate (Aptiom) were presented at the 2015 American Epilepsy Society annual meeting. The analysis demonstrated that eslicarbazepine acetate imparts quality-of-life benefits, improves depression, and reduces hospitalizations in patients with partial-onset seizures.
Originally approved by the FDA in 2013 as adjunctive therapy for partial-onset seizures, eslicarbazepine acetate received a new indication from the FDA in August 2015 for use as monotherapy for patients with partial-onset seizures, making it the only once-daily non–extended-release antiepileptic drug that can be used alone or in combination with other antiepileptic drugs for partial-onset seizures.
The data showing improvement in quality of life and depression came from a post-hoc pooled analysis of 2 phase 3 clinical trials of eslicarbazepine acetate monotherapy involving 224 patients who had completed 10 weeks of monotherapy. Using the Quality-of-Life in Epilepsy-31 (QOLIE-31), a quality-of-life questionnaire that measures items such as medication effects, seizure worry, social functioning, overall quality of life, cognitive functioning, and energy or fatigue, at week 18 the mean change in QOLIE-31 score was greater than the respective standard minimal clinically important difference score.
The Montgomery-Åsberg Depression Rating Scale questionnaire was used to assess the improvement in depressive symptoms in the same post-hoc analysis: 117 of the 224 patients had a clinical response to eslicarbazepine acetate therapy. Overall, >50% of the patients had significant reductions in depressive symptoms.
Another analysis of a large claims database of >53,000 patients with epilepsy who initiated antiepileptic drug monotherapy showed that patients who started therapy with 2, 3, or >3 antiepileptic drugs daily had greater annual hospitalization rates (12.5%, 23.1%, and 19.4% higher, respectively), and emergency department visits than patients who started with 1 drug daily.
“Quality of life assessments provide insights into measurable factors that are important in determining potential treatment outcomes,” said Krithika Rajagopalan, PhD, Head of Global Health Economics and Outcomes Research, Sunovion. “These results suggest improved seizure control with AED [antiepileptic drug] monotherapy is correlated with overall improvements in specific aspects of daily life, as well as fewer hospitalizations.”