Dr Jim Morrow

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Information about Dr Jim Morrow

Published on September 21, 2015

Author: HannahStockdale

Source: slideshare.net

1. Weighing up the risks of harm from AED medication in pregnancy Dr Jim Morrow

2. Major malformations with AED Monotherapy (%) 2,3% Incidence general population* *EUROCAT ** Metaanalysis (Tomson 2008) 2,6% Incidence in women with epilepsy without AED **

3. 3 PB PRM ETM CBZ DZP VPA, CZ CLB VGB LTG GBP1 TPM2 OXC4, LEV5 TGB3 PB CLB = 9 AEDs = 70 years VGB LCM = 10 AEDs = 18 years PGB6, ZNS7 LCM8 AED introduction in UK: 1912–20081,2 CBZ, carbamazepine; CLB, clobazam; CZ, clonazepam; DZP, diazepam; ETM, ethosuximide; GBP, gabapentin; LCM, lacosamide; LEV, levetiracetam; LTG, lamotrigine; OXC, oxcarbazepine; PB, phenobarbitone; PGB, pregabalin; PHT, phenytoin; PRM, primidone; TGB, tiagabine; TPM, topiramate; VGB, vigabatrin; VPA, valproate; ZNS, zonisamide Time 1920 1940 1960 1980 2000 2020 1. Patsalos, P. Seizure 1994; 3; 163-170; 2. SmPC, Topirmate 3. SmPC, Tiagabine; 4. SmPC, Oxcarbazepine 5. SmPC, Levetiracetam; 6. SmPC, Pregabalin 7. SmPC, Zonisamide; 8. SmPc, Lacosamide

4. Malformation risks of antiepileptic drugs in pregnancy: The UK and Ireland Epilepsy and Pregnancy and Register (Est. 1996)  James Morrow, Belfast Neurology  Aline Russell, Glasgow, Neurophysiology  Henry Smithson, Sheffield General Practice  Linda Parsons, Luton Neurology  Ian Robertson, Preston Obstetrics & Gynaecology  Beth Irwin, Belfast Epilepsy Nurse Specialist  Normal Delanty, Dublin Neurology  Patrick Morrison, Belfast, Genetics  John Craig, Belfast Neurology

5. UKEPR . Data collected: First trimester: Information sheet Informed consent Pt details Seizure history AED treatment details Folic acid GP details / specialist EDD Three months post EDD: (GP) Longer term follow up Pregnancy outcome: Neurocognitive delay Gestional age Autistic spectrum disorder Birth weight Mode of delivery Birth defect Additional factors Other Physician involved in care Results of prenatal screening of infant Previous pregnancy outcome(s) Family history of congenital malformation

6.  Number of registrations – 10,625  Number with full outcome data – 8,952  Incomplete registrations – 1673  AED details (full outcome)  Monotherapy = 6569 (73%)  Polytherapy = 1790 (20%)  No AED = 593 (6.7%) Results – 28th August 2015

7. National/International prospective pregnancy registries.

8. Distribution of Verbal IQ (VIQ) According to Monotherapy Drug Exposure In Utero Compared to the Expected Score in the General Population 0 10 20 30 40 50 60 General population Unexposed Carbamazepine Valproate Distribution of verbal IQ Above average (>110) Average (90–109) Low average (80–89) Low (70–79) Exceptionally low (<69) 25 50 16 7 2 9 43 17 24 7 11 54 17 10 8 7 27 24 20 22 1. Adab N, Kini U, Vinten J et al. JNNP 2004;75:1575–1583

9. Guidelines • ‘Pre-conception counselling for women with epilepsy should be routinely delivered ‘ MBRAC 2014 • ‘Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.’ European Medicines Agency 2014 • ‘Where possible, valproate should be avoided in women of childbearing potential.’ International League Against Epilepsy 2015

10. You have a woman on valproate expressing a desire to get pregnant: Measuring risk.

11. Measuring the risk(s): Reduce dose (with a view to stopping) Introduce another drug to regime Switch medication Keep the status quo Seek specialist advice

12. Valproate Carbamazepine Lamotrigine 0 2 4 6 8 10 12 MCMRATE(%) Valproate ≤600mg; Carbamazepine ≤500mg; Lamotrigine ≤200mg Valproate >600-1000mg; Carbamazepine >500-1000mg; Lamotrigine >200-400mg. Valproate >1000mg; Carbamazepine >1000mg; Lamotrigine >400mg *** p=0.006 p=0.26 ** p=0.03 Reducing dose: MCM Rate by AED dose:

13. Introduce another drug (with a view to reducing SVP dose or switching): i.e. Polytherapy

14. 5.2 8.7 3.6 4.2 6.3 2.6 6.2 11.1 4.7 Total With SVP No SVP 0 2 4 6 8 10 12 Polytherapy Comparative MCM rates (%) Total / Including SVP/ Without SVP

15. 5 4.6 13.4 1.39 1.27 7.93 8.61 7.93 18.87 less than 600mg 600- 1000mg Greater than 1000mg 0 2 4 6 8 10 12 14 16 18 20 Polytherapy including SVP Comparative MCM rates (%): by dose

16. Switching to another drug: which drug?

17. 2000 2002 2004 2006 2008 2010 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 LTG 2000 2002 2004 2006 2008 2010 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 SVP 2000 2002 2004 2006 2008 2010 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 MISC 2000 2002 2004 2006 2008 2010 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 CBZ Distribution of treatment as a proportion of the total, over time.

18. Efficacy of AEDs during pregnancy EURAP data EURAP Study Group Neurology 2006;66:354

19. Concentration to dose from before pregnancy and throughout to postpartum Petrenaite et al. Epil Res 2005;65(3):185–188 Nr1 Nr2 Nr3 Nr4 Nr5 Nr6 Nr7 Nr8 Nr9 Nr10 Nr11 140 120 100 80 60 40 20 0 Pre TM1 TM2 TM3 PP Time Individual changes in ratio of lamotrigine plasma levels

20. Keep the status quo Confidential enquiry into maternal deaths 1985-2012 (UK). Years of enquiry Maternities Direct and indirect deaths Ep Deaths 1985-87 2.27m 223 3 1988-90 2.36m 238 9 1991-93 2.32m 228 6 1994-96 2.19m 268 16 1997-99 2.12m 242 9 2000-02 2.00m 261 13 2003-05 2.11m 295 11 2006-08 2.29m 261 14 2009-12 2.37m 226 14 Total 20.06m 2269 95 Maternal death in Epilepsy 10 x background risk

21. Seek specialist advice: N.I. where we are now.  UK Epilepsy and Pregnancy Register (UKEPR)  Pre-conceptual counselling  Regional Joint Epilepsy (Neurology) / Obsteteric clinic RMJH

22. WORK IN PROGRESS

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