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Proposal 674

Title of the Proposed Research

Antiepileptic drug monotherapy for epilepsy: an overview of systematic reviews and network meta-analysis

Lead Researcher

Antony Marson

Affiliation

University of Liverpool
Liverpool, UK

Funding Source

The proposed research is being conducted as part of three year research programme ‘Clinical and cost effectiveness of interventions for epilepsy in the National Health Service (NHS)’ which receives financial support from the National Institute of Health Research (NIHR).

Potential Conflicts of Interest

Lead Researcher: I am coordinator of the National Audit of Seizure Management in Hospitals, which has been funded by a consortium of pharmaceutical companies: GSK, UCB Pharma, Eisai, Viropharma.

Any conflicts of interests of any of the researchers will be disclosed on all publications using the data (including the protocol and planned Cochrane review and any future work that may be conducted). Any existing conflicts of interest will also be disclosed for any conference related work for which the data is used such as abstracts, oral presentations and poster presentations

Data Sharing Agreement Date

9 May 2014

Lay Summary

Epilepsy is a common neurological condition in which recurrent, unprovoked seizures are caused by abnormal electrical discharges from the brain. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure free and go into long-term remission of seizures shortly after starting therapy with a single antiepileptic drug (AED monotherapy). There are currently over 50 drugs available worldwide for the treatment of various seizure and epilepsy types therefore making the correct choice of initial AED therapy for individuals with newly diagnosed seizures is of great importance. This choice should be made using the highest quality evidence regarding potential benefits and harms of various treatments.

The aim of our research is to produce an overview of the effectiveness of ten AEDs currently licenced and used in clinical practice for use as monotherapy: Carbamazepine(CBZ), Phenytoin (PHT), Valproate (VPA), Phenobarbitone (PB), Oxcarbazepine (OXC), Lamotrigine (LTG), Gabapentin (GBP), Topiramate (TPM), Levetiracatam (LEV) and Zonisamide (ZNS). We will review all available evidence regarding the efficacy of the drugs in terms of how well they control seizures and the tolerability of the drugs in terms of side effects reported in clinical trials comparing two or more of the ten specified drugs. We will study two seizure types separately in this overview; generalised onset seizures in which electrical discharges begin in one part of the brain and move throughout the brain, and partial onset seizures in which the seizure is generated in and affects one part of the brain (the whole hemisphere of the brain or part of a lobe of the brain).

Current guidelines from the National Institute of Clinical Excellence (NICE) recommend CBZ or LTG as initial treatment for an individual with newly diagnosed partial seizures and VPA as initial treatment for newly diagnosed generalised seizures. The results of our overview will provide evidence to inform these guidelines for future individuals with newly diagnosed seizures and will provide evidence to inform a choice for decision makers, clinicians or individuals with epilepsy between appropriate drugs available for the initial treatment of epilepsy

Study Data Provided

Study SCAA4001: A Double-blind, Double-dummy, Parallel-group Comparison of Lamotrigine and Divalproex Sodium Initial Monotherapy in Patients with Epilepsy

Statistical Analysis Plan

Publication Citation

http://www.bmj.com/content/357/bmj.j1390

Summary Results

Results summary or link will be posted when available.