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Title: Low Prevalence Of Psychiatric Adverse Events With Keppra (Levetiracetam)

"Low Prevalence Of Psychiatric Adverse Events With Keppra (Levetiracetam)"

LONDON, ENGLAND -- September 8th 2003 - Results from a new study published today in Neurology show that the prevalence of psychiatric adverse events (PAEs) with Keppra* (levetiracetam) is low and not related to start dose or titration schedule1. The new data reaffirm that Keppra is well tolerated, and provide more information on individual patient susceptibility to PAEs, particularly suggesting that past psychiatric profile may be more important in predicting the features of psychiatric side effects than in predicting their occurrence. These results for Keppra compare favourably with data observed with other AEDs**3,4. Study results In this new study, follow-up data from 517 Keppra treated patients at the National Hospital for Neurology and Neurosurgery, London, were evaluated. Results show that 10.1% of patients developed PAEs during Keppra therapy, (classified as 2.5% affective disorder; 1.2% psychosis; 3.5% aggressive behaviour; 2.3% emotional liability and 0.6% other behavioural abnormalities)1, which is in line with what has been reported in placebo controlled clinical trials with Keppra4. There was found to be no relationship between these events and the starting dose of Keppra, or to its titration1. Occurrence of PAEs was not influenced by epilepsy diagnosis, seizure pattern and frequency, or disease duration. A significant association was demonstrated with previous psychiatric history and history of febrile convulsions or status epilepticus. However, previous psychiatric history was less predictive than a history of febrile convulsions or status epilepticus, suggesting that past psychiatric profile may be more important in predicting the features of the PAEs, than their occurrence. These findings support previous clinical trial data, which have also identified a history of psychiatric problems as a risk factor for developing PAEs, while neither dose nor response to treatment (reduction of seizure frequency of = 50 %) had been identified as a prognostic factor2. A recently published study by the same investigators, looking at PAEs in 431 patients treated with the AED topiramate, showed that PAEs occurred in 23.9% of topiramate treated patients3 (10.7% affective disorder, 3.7% psychotic disorder, 5.6% aggressive behaviour and 3.9% other behaviour abnormalities). Professor Michael Trimble, Professor of Behavioural Neurology, Institute of Neurology, London, UK and lead investigator of the study, commented that "Keppra is such an interesting antiepileptic drug, because it renders many previously difficult to treat patients seizure free, and yet it has such a favourable side effect profile when it comes to behavioural problems. In the past, powerful seizure suppressing drugs have provoked more significant psychiatric adverse events." Keppra was discovered and developed in UCB Pharma's research laboratories. UCB, with headquarters in Brussels (Belgium), is a pharmaceutical and chemical company, which operates on a global scale. It employs 12,000 people around the world. It is committed to pharmaceuticals, as well as to technically innovative products in surface specialities for flexible films and coating resins. The pharmaceutical research of UCB includes the following fields: respiratory, including allergy and asthma, and neurology. UCB Pharma's principle products include Zyrtec®, Xyzal® (anti-allergic), Keppra® (antiepileptic), Nootropil® (cerebral function regulator) and Atarax® (tranquilliser). * Keppra is a registered trademark of the UCB Group. Please consult your national product information and regulatory status as they may differ from one country to the other ** These were gabapentin, lamotrigine, tiagabine, topiramate, vigabatrin and zonisamide References 1. Mula M. et al. Psychiatric adverse events during levetiracetam therapy. Neurology 2003; 61: 704 2. French J. et al. A systematic review of the safety profile of levetiracetam: a new antiepileptic drug.Epilepsy Research 2002; 47: 77-90. 3. Mula M. et al. Topiramate and psychiatric adverse events in patients with epilepsy. Epilepsia 2003, 44(5): 659-663. 4. Cramer J.A. et al. A systematic review of the behavioural effects of levetiracetam in adults with epilepsy, cognitive disorders or an anxiety disorder during clinical trials. Epilepsy and Behavior 2003; 4(2): 124-132 SOURCE: Ketchum London

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