(FA-BA107) Onderzoek naar geneesmiddelen - 27
juni 2018
Opleiding: BETA FAR Bachelor Farmacie
Inhoud: Pagina's:
Tijdsduur: 3 uur ▪ A. Voorpagina ..................................................... 1
▪ B. Toets............................................................. 24
Aantal vragen: 30
▪ C. Antwoordformulier .......................................... 2
Gegenereerd op: 27 jun. 2018 ▪ D. Correctiemodel ............................................... 2
Voorpagina - Pagina 1 van 1
9130-13894
, (FA-BA107) Onderzoek naar geneesmiddelen - 27
juni 2018
Opleiding: Bachelor Farmacie
Welkom bij de toets FA-BA107
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Aantal vragen: 30
In totaal zijn 30 punten voor deze toets te behalen, 18,35 punten zijn nodig om voor de
toets te slagen.
(FA-BA107) Onderzoek naar geneesmiddelen - 27 juni
Vragen - Pagina 1 van 24
9130-13894 2018
, Casus 1
Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results
from the UK and Ireland Epilepsy and Pregnancy Registers
ABSTRACT
Objectives Antiepileptic drug (AED) exposure during pregnancy increases the risk of major
congenital malformations (MCMs). The magnitude of this risk varies by AED exposure. Here we
provide updated results from the UK Epilepsy and Pregnancy Register of the risk of MCMs after
monotherapy exposure to valproate, carbamazepine and lamotrigine.
Methods Fifteen-year prospective observational study from 1996 until 2012. The main outcome
measure is the MCM rate.
Results Informative outcomes were available for 5206 cases. 1290 women were exposed to
valproate monotherapy, 1718 to carbamazepine monotherapy and 2198 to lamotrigine
monotherapy. The MCM risk with valproate monotherapy exposure in utero was 6.7% (95% CI
5.5% to 8.3%) compared with 2.6% with carbamazepine (95% CI 1.9% to 3.5%) and 2.3% with
lamotrigine (95% CI 1.8% to 3.1%). A significant dose effect was seen with valproate
(p=0.0006) and carbamazepine ( p=0.03) exposed pregnancies. A non- significant trend
towards higher MCM rate with increasing dose was found with lamotrigine. MCM rate for
high-dose lamotrigine (>400 mg daily) was lower than the MCM rate for pregnancies exposed
to <600 mg daily of valproate, but this was not significant (3.4% vs 5.0%, p=0.31).
Conclusions In utero exposure to valproate carries a significantly higher MCM risk than
lamotrigine (p=0.0001) and carbamazepine (p=0.0001) monotherapy. In contrast to prior
findings, high-dose lamotrigine was associated with fewer MCMs than all doses of valproate.
While lamotrigine has a favourable profile compared with valproate for adverse pregnancy
outcomes, the requirements for seizure control should not be overlooked.
(FA-BA107) Onderzoek naar geneesmiddelen - 27 juni
Vragen - Pagina 2 van 24
9130-13894 2018
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