tolerability and adverse drug reactions of antiepileptic drugs
Research type
Research Study
Full title
effectiveness, tolerability and adverse drug reactions of antiepileptic drugs used in newly diagnosed patients: retrospective observational study
IRAS ID
214663
Contact name
Bshra Alsfouk
Contact email
Sponsor organisation
NHS GGC
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This is a retrospective review of routine clinical data.
This project focuses mainly on adverse drug reaction of the antiepileptic drugs but it links to the efficacy as well. Adverse drug reaction is a major cause of the treatment failure. As they result in the initial discontinuation of the antiepileptic drug in 20% of the patients, impose a negative impact on patient adherence and prevent the usage of the fully therapeutic dosage.
The aims of our study include evaluating the long-term efficacy and tolerability of the antiepileptic drugs and assessing the potential factors that influence the treatment outcomes. Most newer antiepileptuic drugs were reported to have equivalent efficacy to the established agents but have favourable safety profiles in clinical trials. Therefore, tolerability is the fundamental factor in antiepileptic drug selecting.
We plan to use the clinical records maintained by the epilepsy unit of NHSGGC retrospectively to review all newly diagnosed epilepsy patients who start antiepileptic drugs and followed-up for at least one year after commencing the therapy. A total of 1528 eligible patients will be included in the study. We plan to complete the study within a period of 18 months.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0513
Date of REC Opinion
14 Dec 2016
REC opinion
Favourable Opinion