Epidemiology of Valvular Heart Disease in Epilepsy Patients

Study type
Protocol
Date of Approval
Study reference ID
18_305
Lay Summary

The development and management of valvular heart disease, the damage or defect of valves in the heart, has changed over time. However, little is known about the development of valvular heart disease among epilepsy patients. Epilepsy is a condition of the brain in which causes seizures or physical convulsions. This study will attempt to describe the burden of valvular heart disease among epilepsy patients and patients without epilepsy and whether the incidence, the development of new cases, of valvular heart disease is different among age and gender subgroups. Knowledge from this study will inform science of the clinical experiences of epilepsy patients and will add to the paucity of available data.

Technical Summary

This will be a descriptive, exploratory cohort study that will examine the incidence of valvular heart disease among newly diagnosed epilepsy patients, drug-resistant epilepsy patients and patients without epilepsy in real-life clinical practices from the UK Clinical Practice Research Datalink (CPRD). Patients for each study population will be selected from patients with records available between 01-Jan-2006 and the last date available. All study participants are required to have at least two years of medical record with at least one year of data prior to the index date. Newly diagnosed patients will be included if they have a diagnosis of epilepsy or a record of an AED and at least 2 seizure diagnoses. Drug resistant patients will be included if have at least one prior epilepsy diagnosis and 5 AED attempts. Patients without epilepsy will be selected from the set of patients at the same practice as epilepsy patients. All patients will be excluded if they have a record of valvular heart disease prior to index date . Incidence of valvular heart disease will be explored overall and within age and gender. The outcome will be analysed using Poisson regression models or the negative binomial models (if there is over dispersion)

Health Outcomes to be Measured

Valvular Heart Disease

Collaborators

Ahinee Amamoo - Chief Investigator - UCB Pharma GmbH
Ahinee Amamoo - Corresponding Applicant - UCB Pharma GmbH
John Logan - Collaborator - UCB Pharma SA - UK
Nada Boudiaf - Collaborator - UCB BioSciences, Inc.
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Victor Kiri - Collaborator - UCB BioSciences, Inc.