NICE Finds in Favour of Established Epilepsy Drugs
March 24 2004 - 9:55AM
PR Newswire (US)
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
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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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