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Commentary New antiepileptic drugs (AEDs) are almost universally approved initially as adjunctive therapy. The trials that are performed to gain this approval are randomized, placebo-controlled adjunctive trials in patients with frequent, treatmentresistant seizures. Clinicians are often unsatisfied with these studies, since they find them poorly generalizable to the more commonly seen epilepsy patient, with less severe epilepsy. Also, while these trials support that the new drugs are better than placebo, they do not give the clinician a sense of relative efficacy or tolerability in comparison with other antiepileptic drugs that are already available. Moreover, these studies do not determine whether the newly approved medications are effective when used alone, rather than as add-on therapy. Since the evidence for use of the new agents in a less-resistant population is wanting, newly approved AEDs tend to be used initially in the more treatment-resistant patients, who have failed other available therapies. The new study by Kwan and colleagues was performed to address many of these concerns, in relation to the new antiepileptic drug pregabalin (PGB). The study compared pregabalin in a randomized, well-controlled design, not against placebo but against another popular new AED (lamotrigine [LTG]). The Efficacy and Safety of Pregabalin Versus Lamotrigine in Patients With Newly Diagnosed Partial Seizures: A Phase 3, Double-Blind, Randomised, Parallel-Group Trial.

AED Trials in Newly Diagnosed Patients: Out with the Old versus New, in with the New versus New