Integrating clinical trial data into clinical practice.

Abstract

During the past decade, eight new antiepileptic medications (AEDs), including felbamate (FBM), gabapentin (GBP), lamotrigine (LTG), levetiracetam (LEV), oxcarbazepine (OXC), tiagabine (TGB), topiramate (TPM), and zonisamide (ZNS), have been approved in the United States. In multicenter controlled clinical trials, each of these new AEDs has demonstrated efficacy as adjunctive therapy in adults with refractory partial seizures,1-18⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓⇓ and some have shown efficacy as monotherapy in adults with partial seizures.19-27⇓⇓⇓⇓⇓⇓⇓⇓ Although large amounts of data have emerged from these trials, the challenge for clinicians who treat adults with epilepsy has been to integrate these data into their clinical practices. Clinicians who treat children with epilepsy have faced greater obstacles. Only a handful of multicenter controlled clinical trials involving the newer AEDs have been conducted in children with epilepsy. In addition, these studies have focused on answering regulatory questions rather than addressing routine clinical issues. However, it is possible to extract practical and clinically useful information from these multicenter trials by systematically examining specific aspects of the efficacy, safety, and serum concentration trial data. An important factor in evaluating clinical trial data is to determine whether the study’s efficacy data demonstrate the potential usefulness of an AED for children with epilepsy. Direct application of adult clinical trial data to children has many potential hazards. There are a variety of differences between pediatric and adult epilepsy, including age-related seizure types and epilepsy syndromes, etiologic differences in partial seizures between adults and children, and a higher frequency of localization-related epilepsy syndromes in children.28 Therefore, only data from pediatric studies are included in this analysis. The design of the clinical trial is the critical factor determining the potential …