Randomized controlled antiepileptic drug trials miss almost all patients with ongoing seizures

Abstract In spite of the marketing of numerous new antiepileptic drugs (AEDs), their real-life effectiveness has often been disappointing. We therefore retrospectively investigated how many adult patients with drug-resistant epilepsy would have been potential candidates for the last five phase II an...

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Bibliographic Details
Published in:Epilepsy & behavior 2017-01, Vol.66, p.45-48
Main Authors: Steinhoff, Bernhard J, Staack, Anke M, Hillenbrand, Barbara C
Format: Article
Language:English
Subjects:
Adult
Aged
Anticonvulsants - administration & dosage
Anticonvulsants - adverse effects
Anticonvulsants - pharmacology
Antiepileptic drugs
Clinical Trials, Phase II as Topic - standards
Clinical Trials, Phase III as Topic - standards
Drug Resistant Epilepsy - drug therapy
Drug Resistant Epilepsy - epidemiology
Epilepsy
Female
Humans
Incidence
Male
Middle Aged
Neurology
Outcome and Process Assessment (Health Care)
Patient Selection
Practical value
Randomized controlled trials
Randomized Controlled Trials as Topic - standards
Retrospective Studies
Young Adult
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Summary:Abstract In spite of the marketing of numerous new antiepileptic drugs (AEDs), their real-life effectiveness has often been disappointing. We therefore retrospectively investigated how many adult patients with drug-resistant epilepsy would have been potential candidates for the last five phase II and III trials that have been performed at our center. Out of a group of 216 consecutively collected patients, only 18 (8.3%) would have been acceptable for recruitment. Treatment with enzyme-inducing AEDs or concomitant medications (47.2%), too few seizures during a baseline period (41.7%), and EEGs showing a pattern not consistent with a diagnosis of focal epilepsy (e.g. generalized spike-wave) (31.5%) were the leading exclusion criteria. If only one criterion prevented recruitment, too few seizures during the baseline period and treatment with enzyme-inducing medications were the most frequent limitations for potential recruitment. Due to the limiting inclusion and exclusion factors of clinical AED trials, only a small fraction of patients with drug-resistant epilepsy is suitable. When new AEDs have passed such trials and are introduced, we have no information about the potential efficacy and tolerability in > 90% of our patients with AED-resistant epilepsies. This may be one reason for the disappointing efficacy of many new AEDs after launch.
ISSN:1525-5050
1525-5069
DOI:10.1016/j.yebeh.2016.10.025