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Drug trials in epilepsy

BMJ 1996; 313 doi: (Published 09 November 1996) Cite this as: BMJ 1996;313:1158
  1. Gilles Mignot
  1. Clinical pharmacologist La revue Prescrire (English edition, Prescrire International) BP 459, 75527 Paris cedex 11, France

    New drugs have been poorly assessed

    A new generation of antiepileptic drugs has emerged in the past 10 years, including gabapentin, lamotrigine, felbamate, and vigabatrin. These are said to be valuable adjuncts to the first line drugs when epilepsy is inadequately controlled. No agreement exists on the criteria that define treatment failure. One view is that a treatment has failed when seizures are unacceptably frequent despite plasma drug concentrations in the “therapeutic range.” However, this range is defined as the range of concentrations at which most patients have a sizeable reduction in the frequency of seizures without substantial dose dependent side effects. Since some patients require and tolerate larger doses, treatment failure might be better defined as inadequate efficacy at the highest tolerated dose.

    Drug treatment for epilepsy is usually long term and should therefore be as simple as possible. Ideally, …

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