Abstract
An overview is given of the different issues that have been discussed, with subsequent recommendation. Standardisation of measurement and reporting of eficacy parameter and side-effects is essential; not only the number of patients achieving complete seizure controlled or have a decrease in seizure frequency and severity should be mentioned but also the number who dropped out and the reasons therefore. More information is neede on the teratogeneticy of a drug, either by performing control trials or by registration of all pregnancies with new anti‐epileptic drugs. Appropriate bio‐marker for efficacy and toxicity should be developed. Health-related quality of life scales, collecting both subjective and objective information should be developed and used as complimentary tools in understanding more about the disease. A drug that improves the quality of life but is less effective in suppressing seizures should be marketed. Finally, pharmaco‐economic studies should be encuraged in the field of epilepsy.
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Reference
Begley CE, Annegers JF, Lairson DR, Reynolds TF, Hauser WA. Cost of epilepsy in the United States: a model based on incidence and prognosis. Epilepsia 1994;35: 1220–43.
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Kasteleijn-Nolst Trenité, D., Meijer, J. Discussion of the AED workshop.. Pharm World Sci 19, 231–235 (1997). https://doi.org/10.1023/A:1008659110256
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DOI: https://doi.org/10.1023/A:1008659110256