An appraisal of the clinical use of lamotrigine under the special access scheme.
This paper studied the use and efficacy of lamotrigine (LTG), one of the newly developed antiepileptic medications (AEM), released via the Special Access Scheme (SAS). It is argued that the SAS application more closely resembles clinical practice and removes the rigours of clinical drug trialing which of themselves may impose confounding variables into the interpretation of AEM efficacy. Global score evaluation was used to assess efficacy, with scores greater than 4 indicating improvement. Thirty-two patients were administered SAS-LTG, of whom 30 were assessable with a mean duration of therapy of 90 weeks. Twenty-eight (93.3%) patients were assessed at 6 months; 22 (73.3%) patients were assessed at 12 months. Patients with generalised epilepsies received lower doses of LTG than those with partial seizures although this may reflect the use of concomitant sodium valproate (VPA) which is known to increase LTG half life. LTG produced statistically greater global scores in patients with generalised epilepsies (mean 5.6 at 6 months) than for those with partial seizures (mean 4.7 at 6 months). Plasma levels of LTG did not contribute greatly to clinical management. It was concluded that LTG is a relatively safe and effective AEM for certain patients with epilepsy who have proven refractory to the older AEMs. Four patients with refractory generalised seizures were rendered seizure free with the addition of LTG.
Beran
R G
RG
Epilepsy Research and Services, Chatswood, New South Wales, Australia.
Sheehan
K
K