The post-marketing surveillance of gabapentin, lamotrigine and vigabatrin in patients with chronic epilepsy

s 423 Lamotrigine-related rash: an audit I. Wang*, G. Mawer? &J. Sander’ *School of Pharmacy; University of Bradford, Bradford, UK; t David Lewis Centre for Epilepsy Cheshire, UK; $ institute of Neurology National Hospital for Neurology and Neurosurgery, London, UK Purpose: 1. To estimate the incidence of serious and non-serious rashes associated with lamotrigine (LTG) treatment. 2. To identify risk factors for LTG-related rash. 3. To assess the effectiveness of the recommendation by the manufacturers to reduce starting dose. Methods: Case records were surveyed in five tertiary referral epilepsy centres in the UK. The causality of the rash was assessed using the WHO method. Risk factors for LTG-related rash were identified by logistic regression. The incidences of rash before and after reduction in starting dose were compared by Chi-square. Results and discussion: 1050 patients were included. The incidences of serious and non-serious rash were 1.1% (95% CI = 0.5% to 1.8%) and 7% (95% CI = 5.5% to 8.6%). This study confirms previous reports that concurrent sodium valproate and a high starting daily dose increase the risk of LTG-related rash, while concurrent enzyme inducers reduce it. Furthermore, female patients were twice as likely to develop rash than males. Some clinicians ignored the recommendation to start LTG at a lower dose, consequently, there was no reduction in the incidence of LTG-related rash since the manufacturer recommended reducing the starting dose of LTG. The post-marketing surveillance of gabapentin, lamotrigine and vigabatrin in patients with chronic epilepsy I. Wang*, G. Mawet-+ & J. Sander* *School of Pharmacy, University of Bradford, Bradford, UK; + David Lewis School of Epilepsy Cheshire, UK; $ Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK Purpose: A post-marketing surveillance study of gabapentin (GBP), lamotrigine (LTG) and vigabatrin (VGB) investigated adverse drug reactions (ADRs) and mortality. Methods: Case records were surveyed in five tertiary referral epilepsy centres in the UK. Adverse events were recorded and compared within and between the drugs. All deaths were followed and standardized mortality ratios (SMRs) calculated. Serious ADRs were assessed individually. Results and discussion: 1375 patients were included in the statistical analyses. ADRs to GBP were generally mild but one case of leucopenia was identified. Skin rash was the major ADR to LTG but rare cases of hepatic failure, acute exacerbation of ulcerative colitis, disseminated intravascular coagulation and renal failure were also identified. Psychiatric/behavioural disturbance was the major ADR to VGB but one case of visual field constriction was identified. No death could be directly attributed to the use of the new drugs. The SMRs were slightly higher than that reported in the literature. This probably reflects the severity of epilepsy in the study population. Beneficial effect of levetiracetam (UCB L059) on juvenile myoclonic epilepsy resistant to valproate and lamotrigine Kate Smith, Tim Betts & Cathy Fox Birmingham University Seizure Clinic, Queen Elizabeth Psychiatric Hospital, Birmingham B 15 2QZ, UK Levetiracetam (UCB L059) is a new antiepileptic drug (an enantiomer of piracetam) currently undergoing evaluation and already of proven efficacy in patients with partial onset epilepsy. We have examined the effect of this drug on a sub-group of nine patients with juvenile myoclonic epilepsy resistant to conventional therapy with sodium valproate and lamotrigine. Seven of these patients have become totally seizure-free-the other two almost completely so (still in dose escalation). This intriguing result is worthy of further study particularly because Levetiracetam has an acceptable side effect profile.