PHILADELPHIA — Patients who convert from antiepileptic polytherapy to monotherapy with eslicarbazepine acetate (Aptiom) experience improvements in quality of life and fewer hospitalizations, according to data presented at the American Epilepsy Society Annual Meeting in Philadelphia.
Ina poster session, investigators presented data on quality of life improvements in patients treated with Aptiom monotherapy for refractory partial-onset seizures. Data was obtained from two double-blind Phase 3 clinical trials of 224 patients who had completed 10 weeks of monotherapy. The patients were randomly assigned to receive eslicarbazepine acetate 1600 mg or 1200 mg daily; those who demonstrated at least a 50% reduction in frequency of seizures were included for analysis of change in quality of life at baseline and 18 weeks. Change was measured using the Quality of Life in Epilepsy-31 questionnaire.
In total, 107 patients had clinical response and quality of life data. There was significant improvement in total score (mean change 7.71, P<0.001). Further, 52.3% (N=56) had improvement beyond the minimal clinically-important difference (MCID). All subscales of quality of life demonstrated improvement, especially cognitive functioning (mean change 6.58), social functioning (mean change 10.07), seizure worry (mean change 11.51), medication effects (mean change 12.38), and overall QOL (mean change 9.49; P<0.001 for all).1
In a second retrospective analysis of data from a large commercial database, researchers looked at claims by patient’s aged 18 to 65 years with at least 2 antiepileptic medication claims and at least 2 epilepsy diagnoses.
During the study period, the 53,338 participants took an average of 3 pills per day. After adjustment, patients who were prescribed either 2, 3, or more than 3 pills per day were found to have 15.5%, 25.2%, and 15.1% more emergency department (ED) visits per year than those on monotherapy, respectively. Likewise, higher pill burden was associated with higher rates of hospital admissions (12.5%, 23.1%, and 19.4%, respectively).2
“Seizures account for one million emergency department visits every year, and epilepsy has significant impacts on a person’s ability to drive or maintain employment. Quality of life assessments provide insights into measurable factors that are important in determining potential treatment outcomes,” said Krithika Rajagopalan, Head of Global Health Economics and Outcomes Research at Sunovion in a statement. “These results suggest improved seizure control with AED monotherapy is correlated with overall improvements in specific aspects of daily life, as well as fewer hospitalizations.” 3
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Correction: This article has been updated to reflect changes made to patient data included in this analysis.
- Cramer J, Velez F, Bond T, et al. Abstract 1.182. Quality of Life Improvement among Patients with Refractory Partial-Onset Seizures: A Clinical Trial Analysis of Patients Who Responded to Eslicarbazepine Acetate Monotherapy. Presented at: American Epilepsy Society Annual Meeting; Dec. 4-8, 2015; Philadelphia.
- Korsnes JS, Velez F, Candrilli SD. Abstract 2.282.The Association Between Antiepileptic Drug Pill Burden at Monotherapy Initiation and Epilepsy-Related Hospital Admissions and Emergency Department Visits in the United States. Presented at: American Epilepsy Society Annual Meeting; Dec. 4-8, 2015; Philadelphia.
- Sunovion Announces Results of Health Outcomes Analysis Exploring the Effectiveness of Aptiom (eslicarbazepine acetate) in People with Partial-Onset Seizures. Sunovion Pharmaceuticals Inc. Published December 6, 2015. http://www.sunovion.com/news/pressReleases/20151206.pdf. Accessed December 29, 2015.