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Pregabalin (Lyrica) for partial onset epilepsy – monotherapy

Source agency:

NHSC

Date of Submission:

02/10/2009

Date of Printing:

05/02/2012

Disclaimer:

This report is work in progress and should not be used for external distribution without permission from the originating agency. Users should be aware that reports are based on information available at the time of research and often on a limited literature search.

Technology, Company & Licensing

Technology name:

Pregabalin (Lyrica)

Technology - description:

Pregabalin (Lyrica) is an alpha2-delta ligand that has analgesic, anxiolytic and anticonvulsant properties. Pregabalin binds to voltage-gated calcium channels in the central nervous system, modifying the release of neurotransmitters. Pregabalin is administered orally at 150-600mg per day in either two or three divided doses.

Company or developer:

Pfizer Ltd.

Reason for database entry:

New potential technology for epilepsy-monotherapy.

Technology - stage in early warning process:

Assessment complete

Technology - stage of development:

Investigational - phase III

Licensing, reimbursement and other approval:

In phase III trials.

Technology - type(s):

Drug

Technology - use(s):

Therapeutic

Patient Indication & Setting

Patient indications:

Epilepsy: partial onset seizures with or without secondary generalisation – monotherapy.

Disease description and associated mortality and morbidity:

Epilepsy is the most common serious neurological condition in the UK (5)and is characterised by recurrent, unprovoked seizures (i.e. not an isolated event or due to an underlying acute reversible medical problem such as meningitis or alcohol withdrawal)(6). An epileptic seizure is a brief disturbance of consciousness, behaviour, emotion, motor function, and/or sensation that is due to abnormal electrical discharge in the brain (6). Epilepsy is not usually diagnosed unless the person has had at least two unprovoked seizures (1).

Partial-onset seizures are classified as simple partial seizures and complex partial seizures, either of which may lead to secondary generalised tonic-clonic seizures. The defining element of simple partial seizures is a seizure with preserved consciousness and this group includes sensory, motor, autonomic, and psychic types. Many patients with complex partial seizures have an aura warning them of their seizure. Diagnosis is based on the repeated, stereotypic occurrence of the same experience supported in some cases by focal changes on an EEG.

Number of Patients:

About 1 in 200 of the population receives treatment for epilepsy and the lifetime prevalence is estimated between 2% and 5% (7). Epilepsy affects between 260,000 and 416,000 people in England and Wales. The reported prevalence increases with age, from 3.9 per 1,000 population at age 7 years to 4.9 per 1,000 population at 16 years (2).

Technology - specialities(s):

Neurology & neurosurgery

Technology - setting(s):

Community and primary care

Setting - further information:

 

Impact

Alternative and/or complementary technology:

Other

Current Technology:

Current NICE guidelines recommend monotherapy with an antiepileptic drug (AED) where possible (1).
•If the older drugs (such as sodium valproate and carbamazepine) do not stop seizures, or if there are side effects, one of the newer drugs can be tried, as long as it is suitable for that type of epilepsy.
•Gabapentin, lamotrigine, levetiracetam, oxcarbazepine and topiramate can be given as monotherapy, or if they do not control seizures, in combination with another drug.
•Clobazam, lacosamide, pregabalin, tiagabine, vigabatrin and zonisamide are used as combination therapy (adjunctive or add-on therapy) with another drug.

Health Impact:

May reduce morbidity and improve quality of life for patients and/or carers.

Diffusion:

-

Cost, infrastructure and economic consequences:

The cost of pregabalin 150-600mg per day in 2 or 3 divided doses is between £64-97 for 28 days.

Ethical, social, legal, political and cultural impact:

-

Evidence & Policy

Clinical evidence and safety:

Trial: NCT00280059 (8), A0081046; partial epilepsy; pregabalin vs lamotrigine; phase III.
Sponsor: Pfizer Ltd.
Status: Ongoing.
Location: Europe (inc UK), SE Asia and Latin America.
Design: Randomised, double-blind.
Participants and schedule: n=626; ≥16 yrs; partial epilepsy; 2 partial seizures within1 yr with 1 within 6 mnths; naive to AED or single AED <14 days prior to screening. Randomised to pregabalin 150-600mg or lamotrigine 100-500mg twice daily.
Follow-up: Active treatment period 56 weeks.
Primary outcome: 6-month seizure freedom.
Secondary outcomes: Time to 6–month seizure freedom; time to first seizure; 28-day seizure rate; maintenance of 6-month seizure freedom; 6-months seizure freedom; hospital anxiety and depression scale (HADS); medical outcomes study (MOS); sleep scale.
Expected reporting date: Expected date of final analysis Q2-3/2010.

Economic evaluation:

-

Ongoing research:

-

Ongoing or planned HTA:

-

Web link:

http://www.nhsc-healthhorizons.org.uk/outputs/specialties/

References and sources:

1) National Institute for Health and Clinical Excellence. The clinical effectiveness and cost effectiveness of newer drugs for epilepsy in adults. Technology appraisal TA76. London: NICE; March 2004
2) National Institute for Health and Clinical Excellence. The diagnosis and management of the epilepsies in adults and children in primary and secondary care. Clinical Guideline CG20. London: NICE; October 2004.
3) Scottish Intercollegiate Guidelines Network. Diagnosis and management of epilepsy in adults. Edinburgh: SIGN; April 2003.
4) Whiting P, Gupta R, Burch J et al. A systematic review of the effectiveness and cost-effectiveness of neuroimaging assessments used to visualise the seizure focus in people with refractory epilepsy being considered for surgery. Health Technology Assessment 2006; 10 (4).
5) National Society for epilepsy. What is epilepsy? http://www.epilepsynse.org.uk/AboutEpilepsy/Whatisepilepsy Accessed 27 August 2009.
6) Clinical Knowledge Summaries. Epilepsy. http://cks.library.nhs.uk/epilepsy#-218621 Accessed 27 August 2009.
7) Patient UK. Managing epilepsy in primary care. http://www.patient.co.uk/doctor/Managing-Epilepsy-in-Primary-Care.htm Accessed 11th September 2009.
8) ClinicalTrials.gov. Study of the safety and efficacy of lyrica in the treatment of newly diagnosed partial epilepsy. http://www.clinicaltrials.gov/ct2/show/NCT00280059?term=NCT00280059&rank=1 Accessed 12 August 2009.
9) British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BMJ Group and RPS Publishing. London; March 2009.

Notes: