NICE Finds in Favour of Established Epilepsy Drugs LONDON, March 24 /PRNewswire/ -- The National Institute for Clinical Excellence (NICE) has today recommended that the first line treatment of epilepsy in adults should continue to be based on established medications such as sodium valproate. The NICE report concluded that newer epilepsy drugs do not improve seizure control or quality of life compared to the standard treatments (sodium valproate or carbamazepine) and should only be used when these treatments are ineffective or unsuitable. The recommendations were made by the NICE Health Technology Appraisal on the clinical and cost effectiveness of drugs reviewed for the treatment of epilepsy in adults. The newer antiepileptic drugs reviewed included gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate and vigabatrin. The NICE report illustrates the need for pre-conception counselling for all women with epilepsy. Whilst NICE advises caution with the use of sodium valproate in women of childbearing potential, NICE also states that with some types of seizures, sodium valproate may be an appropriate drug for these women provided that an informed choice has been made. These recommendations concur with established information given to both prescribers and patients within the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) for sodium valproate. "The publication of guidelines into the management of epilepsy isa further step in addressing the difficulties people with epilepsy have in accessing good quality care," said Professor Mike Kerr, Epilepsy Specialist at the University of Wales College of Medicine, Cardiff. "Patient informed choice is an important factor in antiepileptic drug choice and clinicians must recognise this. Choice is complex, particularly for women of childbearing potential, and needs discussion between the patient and a skilled specialist." Epilepsy is the most common serious neurological condition in the UK.(1) One person in 50 will have epilepsy at some time in their life.(2) Epilepsy is not a benign condition; approximately 1000 people die annually as a result of epilepsy, mostly as a consequence of seizures.(1) Seizure control is therefore paramount. Sodium valproate has been marketed as Epilim in the UK since 1974 for the treatment of epilepsy. Sodium valproate has been shown over many years to be effective against almost all epilepsy and seizure types and is generally well tolerated.(3) Sodium valproate is licensed in patients of all ages. The full text of the NICE Technology Appraisal Report is available on the NICE website (http://www.nice.org.uk) Notes to Editors: Epilepsy is the most common serious neurological condition in the UK. Epilepsy is not a benign condition - about 1000 people die annually as a result of epilepsy, most as a result of seizures(1). Seizure control is therefore paramount. All first line antiepileptic medications listed in current UK guidelines and the NICE appraisal have a potential to be associated with major congenital malformation.(4) An increased risk of major malformations in children born to mothers with epilepsy receiving valproate during the first trimester of pregnancy, as well as other standard antiepileptic drugs (AEDs) has been described.(4) Approximately 94% of pregnancies in women taking sodium valproate will have a normal outcome with respect to major congenital malformation, compared to about 98% in the untreated population with epilepsy.(4) With regard to the newer agents, there are currently insufficient data to assess their risk properly. In addition, the respective roles played by treatments and the epilepsy condition itself have not been formally established. Consequently, it is widely acknowledged that women with epilepsy planning to conceive should be reviewed and counselled appropriately with regard to antiepileptic therapy. Notably, unlikemany other antiepileptic medicines, sodium valproate does not compromise the effectiveness of the oral contraceptive pill.(5) Notwithstanding the potential risks, it is of utmost importance that patients with epilepsy do not stop their medication without first consulting their doctor as this may lead to breakthrough seizures that could have harmful and even fatal consequences for both the mother and baby. (6) Therefore, seizure control must be the goal of medical therapy. Selection of the most appropriate antiepileptic medication must be made by the patient and the specialist on the basis of informed choice. All women on antiepileptic treatment should receive specialist neurological advice before conception. Women should not stop taking their medication without consulting a specialist.(7) Where a woman decides to stay on sodium valproate steps can be taken that may reduce the risks.(8) These include: - Monotherapy at the lowest effective dose, in divided doses and if possible, as a prolonged release preparation - Initiation of folate supplementation. Women should take 5mg folic acid as soon as contraception is discontinued. References 1. Epilepsy - Death in the Shadows. National Sentinel. National Clinical Audit Of Epilepsy Related Deaths, May 2002. 2. The National Society for Epilepsy http://www.epilepsynse.org.uk/pages/info/leaflets/epfacts.cfm. 3. Perucca E. Pharmacological and therapeutic properties of valproate. A summary after 35 years of clinical experience. CNS Drugs 2002; 16: 695-714. 4. Russell et al. The UK Epilepsy and Pregnancy Register Interim results. Association of British Neurologists, Glasgow. October 1st-3rd October 2003. 5. Epilim SPC 6.Yerba. Clinical Care Of Pregnant Women with Epilepsy: Neural Tube Defects and Folic Acid Supplementation. Epilepsia 2003; 44 (Suppl. 3) 33-40. 7. SIGN Diagnosis and Management of Epilepsy in Adults: A national clinical guideline. April 2003. 8. Committee on Safety and Medicines. Sodium valproate and prescribing in pregnancy. Current Problems in Pharmacovigilance (Vol 29 September 2003). About Sanofi-Synthelabo Sanofi-Synthelabo is a major global research-based pharmaceutical group with 32,500 employees in more than 100 countries. The company is headquartered in Paris and listed in Paris (Euronext : SAN) and in New York (NYSE : SNY). With consolidated sales of EUR 7.4 billion in 2002, Sanofi-Synthelabo ranks 7th in Europeand among the world's top 20 pharmaceutical companies. With an R&D portfolio of 55 compounds in development, Sanofi-Synthelabo is focused on a core group of four therapeutic areas: cardiovascular disease and thrombosis; diseases of the central nervous system; internal medicine; and oncology. Please visit our web site: www.sanofi-synthelabo.com DATASOURCE: Sanofi-Synthelabo Limited For further information and/or interviews with UK epilepsy specialists please contact: Jeni Wilson, Brand Communications Manager, Sanofi-Synthelabo, DD: +44-(0)1483-554177, Fax: +44-(0)1483-554801, Mobile: +44-(0)7734-855-903 , Email:jennifer.wilson@sanofi-synthelabo.com; Cressida Ward, Head of Communications, Sanofi-Synthelabo, DD: +44-(0)1483-554072, Fax: +44-(0)1483-554801, Mobile: +44-(0)7740-935304, Email:cressida.ward@sanofi-synthelabo.com

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