Epilepsy is characterised by the repeated occurrence of seizures caused by episodes of abnormal electrical activity in the brain. In order to prevent seizures, people with epilepsy are commonly treated with anti-epileptic drugs. Several anti-epileptic drugs are available and the choice of anti-epileptic drug prescribed is likely to depend on the cause of the epilepsy, the type of seizure, the patient's medical history and cost. Perampanel, eslicarbazepine and rufinamide are three newer anti-epileptic drugs. In this study, we wish to study patients prescribed perampanel, eslicarbazepine and rufinamide in the CPRD dataset and describe their patient characteristics. In addition, we aim to compare the frequency of seizures, associated events and side effects and also the cost of healthcare before and after initiation of the study drug. Furthermore, we intend to compare patients treated with perampanel, eslicarbazepine and rufinamide to other patients with epilepsy so that they are as similar as possible. We will then compare the frequency of seizures, the frequency of side effects and healthcare costs between patients prescribed perampanel, eslicarbazepine and rufinamide and their matched groups.
A retrospective cohort study using CPRD GOLD will be conducted. Data from HES inpatient, outpatient and accident and emergency datasets and the patient level Townsend score will be utilised in a sensitivity analysis in patients eligible for linkage. Acceptable patients, registered at an up-to-standard practice will be included in the study if they have received a prescription for perampanel, eslicarbazepine or rufinamide from 2008 onwards and have a first prescription for a study drug recorded in CPRD GOLD >365 days after their date of registration. The baseline characteristics of the cases and the frequency of prescriptions for the study drugs will be described. Cases will be matched by propensity score to one control patient with the same epilepsy syndrome, seizure type and concomitant antiepileptic drug(s) initiating an antiepileptic therapy recommended at the same point in the treatment pathway. Frequency of seizures and adverse events and number of antiepileptic regimen changes will be compared prior to and post initiation and between cases and controls. Standard published NHS healthcare costs will be attributed to healthcare resource use. Healthcare resource use and the associated costs will be compared using the Wilcoxon signed rank test.
Healthcare resource use; Frequency of adverse event; Healthcare costs; Seizure frequency.
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Townsend Score