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Article ; Online: Economic evaluation of anti-epileptic drug therapies with specific focus on teratogenic outcomes.

Jentink, Janneke / Boersma, Cornelis / de Jong-van den Berg, Lolkje T W / Postma, Maarten J

2012 Volume 15, Issue 5, Page(s) 862–868

Abstract: Background: Anti-epileptic drugs are known to be teratogenic, yet many women do need to continue the anti-epileptic drug use during pregnancy.: Objectives: To perform an economic evaluation of the anti-epileptic drug choice in young women who ... ...

Abstract	Background: Anti-epileptic drugs are known to be teratogenic, yet many women do need to continue the anti-epileptic drug use during pregnancy. Objectives: To perform an economic evaluation of the anti-epileptic drug choice in young women who potentially wish to become pregnant. In particular, to estimate the impact of teratogenicity on the costs per quality adjusted life year (QALY). Methods: A decision-tree model is used to calculate the costs per QALY, taking into account the malformation risk in offspring due to the exposure to carbamazepine, lamotrigine or valproic acid, based on the European birth cohort of 2007. Probabilistic sensitivity analyses were performed using Monte Carlo simulation. Results: Valproic acid is dominated by carbamazepine after rank ordering on costs. The incremental cost-effectiveness of lamotrigine vs carbamazepine was estimated at €175,534 per QALY. Although valproic acid was dominated by carbamazepine in terms of costs and related effects, it is clinically relevant to compare lamotrigine with valproic acid. In particular, treatment options are dependent on several individual and clinical characteristics and these agents are therefore not always considered as interchangeable for all specified populations. The incremental cost-effectiveness for lamotrigine vs valproic acid was estimated at €13,370 per QALY. With assuming a willingness to pay threshold of €50,000 per QALY, results from the probabilistic analysis resulted in an acceptance level for lamotrigine vs carbamazepine and lamotrigine vs valproic acid of 4% and 99%, respectively. Conclusion: Based on epidemiological data it is advised to whenever possible avoid valproic acid during pregnancy. Both carbamazepine and lamotrigine are estimated to be cost-effective treatment options vs valproic acid if focused on teratogenicity.
MeSH term(s)	Abnormalities, Drug-Induced/economics ; Adolescent ; Anticonvulsants/adverse effects ; Anticonvulsants/economics ; Carbamazepine/adverse effects ; Carbamazepine/economics ; Cost-Benefit Analysis ; Epilepsy/drug therapy ; Female ; Humans ; Monte Carlo Method ; Netherlands ; Outcome Assessment (Health Care)/economics ; Pregnancy ; Pregnancy Complications/drug therapy ; Pregnancy Complications/psychology ; Quality-Adjusted Life Years ; Triazines/adverse effects ; Triazines/economics ; Valproic Acid/adverse effects ; Valproic Acid/economics ; Young Adult
Chemical Substances	Anticonvulsants ; Triazines ; Carbamazepine (33CM23913M) ; Valproic Acid (614OI1Z5WI) ; lamotrigine (U3H27498KS)
Language	English
Publishing date	2012
Publishing country	England
Document type	Comparative Study ; Journal Article
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.3111/13696998.2012.684366
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Article ; Online: Evaluation of the representativeness of a Dutch non-malformed control group for the general pregnant population: are these controls useful for EUROCAT?

Jentink, Janneke / Zetstra-van der Woude, A Priscilla / Bos, Jens / de Jong-van den Berg, Lolkje T W

Pharmacoepidemiology and drug safety

2011 Volume 20, Issue 11, Page(s) 1217–1223

Abstract: Purpose: A case-control study is the most powerful design to test the risk of specific congenital malformations associated with a specific drug. However, malformation registries often lack non-malformed controls. For the Dutch EUROCAT, we collected a ... ...

Abstract	Purpose: A case-control study is the most powerful design to test the risk of specific congenital malformations associated with a specific drug. However, malformation registries often lack non-malformed controls. For the Dutch EUROCAT, we collected a non-malformed control group: the 'Healthy Pregnant'. The aim of this study was to evaluate the representativeness of this control group for the general pregnant population in the northern part of the Netherlands. Methods: The Healthy Pregnant data set includes data from two midwife practices. The baseline characteristics of mother and child including smoking status, drinking status, body mass index, maternal age, educational level, exposures to several drugs for chronic diseases and pregnancy related symptoms were evaluated. Results: Compared with the general population, mothers in Healthy Pregnant group (n = 556) were from either low or high education level, were more likely to have a body mass index > 25 kg/m² (26% versus 22%, p = 0.08) or to smoke (19% versus 10%, p < 0.01) but were less likely to consume alcohol (20% versus 29%, p < 0.01). The use of drugs for chronic conditions was lower in Healthy Pregnant group. Furthermore, drugs for occasional use were prescribed less frequently, and a significant underreporting of children with a low birth weight and a short duration of gestation was found. Conclusion: The Healthy Pregnant data set was not representative of the general pregnant population in the northern part of the Netherlands. Specifically, the exposure to (chronic) drugs was underestimated, possibly a result of second-line care on the basis of medical indication. Thus, continuous investigation of options for improvement of the Healthy Pregnant database is required.
MeSH term(s)	Abnormalities, Drug-Induced/diagnosis ; Abnormalities, Drug-Induced/epidemiology ; Alcohol Drinking/epidemiology ; Body Mass Index ; Case-Control Studies ; Chronic Disease/drug therapy ; Control Groups ; Databases, Factual/statistics & numerical data ; Drug Users/statistics & numerical data ; Ethanol ; Female ; Humans ; Infant ; Infant, Low Birth Weight ; Infant, Newborn ; Longitudinal Studies ; Maternal Age ; Models, Statistical ; Mothers ; Neonatal Screening ; Netherlands/epidemiology ; Pharmaceutical Preparations/metabolism ; Pregnancy ; Registries/statistics & numerical data ; Risk Factors ; Smoking
Chemical Substances	Pharmaceutical Preparations ; Ethanol (3K9958V90M)
Language	English
Publishing date	2011-11
Publishing country	England
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.2254
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Article ; Online: Does folic acid use decrease the risk for spina bifida after in utero exposure to valproic acid?

Jentink, Janneke / Bakker, Marian K / Nijenhuis, Cynthia M / Wilffert, Bob / de Jong-van den Berg, Lolkje T W

Pharmacoepidemiology and drug safety

2010 Volume 19, Issue 8, Page(s) 803–807

Abstract: Purpose: Women with child wish are advised to take folic acid supplements to reduce the risk for spina bifida. However, there is less evidence for this protective effect in women using valproic acid (VPA). We investigated the effect of folic acid in ... ...

Abstract	Purpose: Women with child wish are advised to take folic acid supplements to reduce the risk for spina bifida. However, there is less evidence for this protective effect in women using valproic acid (VPA). We investigated the effect of folic acid in women exposed to VPA in the first trimester of pregnancy. Methods: A case-control study was performed with data from a population-based registry of congenital malformations. Our cases were spina bifida registrations and all other malformed registrations (excluding folic acid sensitive malformations) were used as controls. Results: The ORs for the effect of correct folic acid use were calculated among antiepileptic drug (AED) unexposed pregnancies 0.5 [95%CI: 0.3-0.7] and among VPA exposed pregnancies 1.0 [95%CI: 0.1-7.6]. Discussion: Due to power-reasons, we cannot conclude that folic acid has no effect on the risk for spina bifida among VPA exposed pregnancies. Although for AED unexposed pregnancies we found a decreased risk. Results from (animal) studies support a biologically plausible association between VPA, folic acid and spina bifida. While folic acid might not be able to reduce the risk for lower spina bifida lesions caused by VPA, the use of folic acid might be important to reduce the risk for higher, folic acid sensitive spina bifida lesions. Further research is needed to get more insight in the most effective form and dose of FA in women that use VPA to reduce the risk for (higher forms of) spina bifida.
MeSH term(s)	Abnormalities, Drug-Induced/etiology ; Abnormalities, Drug-Induced/prevention & control ; Anticonvulsants/adverse effects ; Anticonvulsants/therapeutic use ; Case-Control Studies ; Dietary Supplements ; Female ; Folic Acid/therapeutic use ; Humans ; Infant, Newborn ; Pregnancy ; Pregnancy Trimester, First ; Risk Factors ; Spinal Dysraphism/prevention & control ; Valproic Acid/adverse effects ; Valproic Acid/therapeutic use
Chemical Substances	Anticonvulsants ; Valproic Acid (614OI1Z5WI) ; Folic Acid (935E97BOY8)
Language	English
Publishing date	2010-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.1975
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Article ; Online: Intrauterine exposure to carbamazepine and specific congenital malformations: systematic review and case-control study.

Jentink, Janneke / Dolk, Helen / Loane, Maria A / Morris, Joan K / Wellesley, Diana / Garne, Ester / de Jong-van den Berg, Lolkje

BMJ (Clinical research ed.)

2010 Volume 341, Page(s) c6581

Abstract: Objective: To identify specific major congenital malformations associated with use of carbamazepine in the first trimester of pregnancy.: Design: A review of all published cohort studies to identify key indications and a population based case-control ...

Abstract	Objective: To identify specific major congenital malformations associated with use of carbamazepine in the first trimester of pregnancy. Design: A review of all published cohort studies to identify key indications and a population based case-control study to test these indications. Setting: Review of PubMed, Web of Science, and Embase for papers about carbamazepine exposure in the first trimester of pregnancy and specific malformations, and the EUROCAT Antiepileptic Study Database, including data from 19 European population based congenital anomaly registries, 1995-2005. Participants: The literature review covered eight cohort studies of 2680 pregnancies with carbamazepine monotherapy exposure, and the EUROCAT dataset included 98 075 registrations of malformations covering over 3.8 million births. Main outcome measures: Overall prevalence for a major congenital malformation after exposure to carbamazepine monotherapy in the first trimester. Odds ratios for malformations with exposure to carbamazepine among cases (five types of malformation identified in the literature review) compared with two groups of controls: other non-chromosomal registrations of malformations and chromosomal syndromes. Results: The literature review yielded an overall prevalence for a major congenital malformation of 3.3% (95% confidence interval 2.7 to 4.2) after exposure to carbamazepine monotherapy in the first trimester. In 131 registrations of malformations, the fetus had been exposed to carbamazepine monotherapy. Spina bifida was the only specific major congenital malformation significantly associated with exposure to carbamazepine monotherapy (odds ratio 2.6 (95% confidence interval 1.2 to 5.3) compared with no antiepileptic drug), but the risk was smaller for carbamazepine than for valproic acid (0.2, 0.1 to 0.6). There was no evidence for an association with total anomalous pulmonary venous return (no cases with carbamazepine exposure), cleft lip (with or without palate) (0.2, 0.0 to 1.3), diaphragmatic hernia (0.9, 0.1 to 6.6), or hypospadias (0.7, 0.3 to 1.6) compared with no exposure to antiepileptic drugs. Further exploratory analysis suggested a higher risk of single ventricle and atrioventricular septal defect. Conclusion: Carbamazepine teratogenicity is relatively specific to spina bifida, though the risk is less than with valproic acid. Despite the large dataset, there was not enough power to detect moderate risks for some rare major congenital malformations.
MeSH term(s)	Abnormalities, Drug-Induced/epidemiology ; Abnormalities, Drug-Induced/etiology ; Anticonvulsants/adverse effects ; Carbamazepine/adverse effects ; Case-Control Studies ; Epilepsy/drug therapy ; Epilepsy/epidemiology ; Europe/epidemiology ; Female ; Humans ; Infant, Newborn ; Pregnancy ; Pregnancy Complications/drug therapy ; Pregnancy Complications/epidemiology ; Pregnancy Trimester, First ; Prenatal Exposure Delayed Effects/epidemiology ; Prenatal Exposure Delayed Effects/etiology ; Prevalence ; Risk Factors
Chemical Substances	Anticonvulsants ; Carbamazepine (33CM23913M)
Language	English
Publishing date	2010-12-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.c6581
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Article ; Online: Valproic acid monotherapy in pregnancy and major congenital malformations.

Jentink, Janneke / Loane, Maria A / Dolk, Helen / Barisic, Ingeborg / Garne, Ester / Morris, Joan K / de Jong-van den Berg, Lolkje T W

The New England journal of medicine

2010 Volume 362, Issue 23, Page(s) 2185–2193

Abstract: Background: The use of valproic acid in the first trimester of pregnancy is associated with an increased risk of spina bifida, but data on the risks of other congenital malformations are limited.: Methods: We first combined data from eight published ... ...

Abstract	Background: The use of valproic acid in the first trimester of pregnancy is associated with an increased risk of spina bifida, but data on the risks of other congenital malformations are limited. Methods: We first combined data from eight published cohort studies (1565 pregnancies in which the women were exposed to valproic acid, among which 118 major malformations were observed) and identified 14 malformations that were significantly more common among the offspring of women who had received valproic acid during the first trimester. We then assessed the associations between use of valproic acid during the first trimester and these 14 malformations by performing a case-control study with the use of the European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database, which is derived from population-based congenital-anomaly registries. Registrations (i.e., pregnancy outcomes with malformations included in EUROCAT) with any of these 14 malformations were compared with two control groups, one consisting of infants with malformations not previously linked to valproic acid use (control group 1), and one consisting of infants with chromosomal abnormalities (control group 2). The data set included 98,075 live births, stillbirths, or terminations with malformations among 3.8 million births in 14 European countries from 1995 through 2005. Results: Exposure to valproic acid monotherapy was recorded for a total of 180 registrations, with 122 registrations in the case group, 45 in control group 1, and 13 in control group 2. As compared with no use of an antiepileptic drug during the first trimester (control group 1), use of valproic acid monotherapy was associated with significantly increased risks for 6 of the 14 malformations under consideration; the adjusted odds ratios were as follows: spina bifida, 12.7 (95% confidence interval [CI], 7.7 to 20.7); atrial septal defect, 2.5 (95% CI, 1.4 to 4.4); cleft palate, 5.2 (95% CI, 2.8 to 9.9); hypospadias, 4.8 (95% CI, 2.9 to 8.1); polydactyly, 2.2 (95% CI, 1.0 to 4.5); and craniosynostosis, 6.8 (95% CI, 1.8 to 18.8). Results for exposure to valproic acid were similar to results for exposure to other antiepileptic drugs. Conclusions: The use of valproic acid monotherapy in the first trimester was associated with significantly increased risks of several congenital malformations, as compared with no use of antiepileptic drugs or with use of other antiepileptic drugs.
MeSH term(s)	Abnormalities, Drug-Induced/epidemiology ; Abnormalities, Drug-Induced/etiology ; Anticonvulsants/adverse effects ; Anticonvulsants/therapeutic use ; Case-Control Studies ; Cohort Studies ; Female ; Humans ; Infant, Newborn ; Male ; Pregnancy ; Pregnancy Complications/drug therapy ; Pregnancy Trimester, First ; Prenatal Exposure Delayed Effects/chemically induced ; Prenatal Exposure Delayed Effects/epidemiology ; Prevalence ; Risk Factors ; Valproic Acid/adverse effects ; Valproic Acid/therapeutic use
Chemical Substances	Anticonvulsants ; Valproic Acid (614OI1Z5WI)
Language	English
Publishing date	2010-06-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa0907328
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Ua VI Zs.34: Show issues

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Article ; Online: Economic evaluation of folic acid food fortification in The Netherlands.

Jentink, Janneke / van de Vrie-Hoekstra, Nienke W / de Jong-van den Berg, Lolkje T W / Postma, Maarten J

European journal of public health

2008 Volume 18, Issue 3, Page(s) 270–274

Abstract: Background: Folic acid intake before and during pregnancy reduces neural tube defects (NTD). Therefore, several countries have enriched bulk food with folic acid resulting in a 26-48% decrease in the prevalence of NTDs. In 2000, the Dutch Health Council ...

Abstract	Background: Folic acid intake before and during pregnancy reduces neural tube defects (NTD). Therefore, several countries have enriched bulk food with folic acid resulting in a 26-48% decrease in the prevalence of NTDs. In 2000, the Dutch Health Council advised against folic acid enrichment based on literature research; yet formal cost-effectiveness information was absent. We designed our study to estimate cost-effectiveness of folic acid food fortification in the Netherlands. Method: Prevalence of NTD at birth, life-time costs of care, and folic acid fortification costs were estimated using Dutch registrations, Dutch guidelines for costing, (inter)national literature and expert opinions. Both net cost per discounted life year gained and net cost per discounted quality adjusted life year (QALY) gained were estimated for the base case and sensitivity analyses. Results: In the base case and most sensitivity analyses, folic acid enrichment was estimated to be cost-saving. Bulk food fortification with folic acid remains cost-effective as long as enrichment costs do not exceed euro5.5 million (threshold at euro20 000 per QALY). Conclusion: Our model suggests that folic acid fortification of bulk food to prevent cases of NTD in newborns might be a cost-saving intervention in the Netherlands. Additionally, besides the evidence that folic acid reduces the number of NTDs, there are indications that folic acid is associated with the prevention of other birth defects, cardiovascular diseases and cancer. Our model did not yet include these possibly beneficial effects.
MeSH term(s)	Cost-Benefit Analysis ; Dietary Supplements/utilization ; Female ; Folic Acid/administration & dosage ; Folic Acid/economics ; Food, Fortified/economics ; Humans ; Netherlands/epidemiology ; Neural Tube Defects/economics ; Neural Tube Defects/epidemiology ; Neural Tube Defects/prevention & control ; Pregnancy ; Pregnancy Outcome ; Prenatal Nutritional Physiological Phenomena ; Prevalence ; Quality-Adjusted Life Years
Chemical Substances	Folic Acid (935E97BOY8)
Language	English
Publishing date	2008-06
Publishing country	England
Document type	Journal Article
ZDB-ID	1129243-x
ISSN	1464-360X ; 1101-1262
ISSN (online)	1464-360X
ISSN	1101-1262
DOI	10.1093/eurpub/ckm129
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Zs.A 3499: Show issues

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Article: The distribution of congenital anomalies within the VACTERL association among tumor necrosis factor antagonist-exposed pregnancies is similar to the general population.

Crijns, Hubertina J M J / Jentink, Janneke / Garne, Ester / Gispen-de Wied, Christine C / Straus, Sabine M J M / de Jong-van den Berg, Lolkje T W

The Journal of rheumatology

2011 Volume 38, Issue 9, Page(s) 1871–1874

Abstract: Objective: To compare the distribution of congenital anomalies within the VACTERL association (vertebral defects, anal atresia, cardiac, tracheoesophageal, renal, and limb abnormalities) between patients exposed to tumor necrosis factor-α (TNF-α) ... ...

Abstract	Objective: To compare the distribution of congenital anomalies within the VACTERL association (vertebral defects, anal atresia, cardiac, tracheoesophageal, renal, and limb abnormalities) between patients exposed to tumor necrosis factor-α (TNF-α) antagonist and the general population. Methods: Analysis for comparison of proportional differences to a previous publication between anomaly subgroups, according to subgroup definitions of the European Surveillance of Congenital Anomalies (EUROCAT), a population-based database. Results: Most EUROCAT subgroups belonging to the VACTERL association contained only one or 2 records of TNF-α antagonist exposure, so comparison of proportions was imprecise. Only the category "limb abnormalities" showed a significantly higher proportion in the general population. Conclusion: The high number of congenital anomalies belonging to the VACTERL association from a report of pregnancies exposed to TNF-α antagonists could not be confirmed using a population-based congenital anomaly database.
MeSH term(s)	Abnormalities, Drug-Induced/classification ; Abnormalities, Drug-Induced/epidemiology ; Abnormalities, Drug-Induced/physiopathology ; Adult ; Anal Canal/abnormalities ; Cohort Studies ; Databases, Factual ; Esophagus/abnormalities ; Europe/epidemiology ; Female ; Heart Defects, Congenital/chemically induced ; Heart Defects, Congenital/epidemiology ; Humans ; Immunologic Factors/adverse effects ; Infant, Newborn ; Kidney/abnormalities ; Limb Deformities, Congenital/chemically induced ; Limb Deformities, Congenital/epidemiology ; Pregnancy ; Prenatal Exposure Delayed Effects ; Spine/abnormalities ; Trachea/abnormalities ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; Tumor Necrosis Factor-alpha/physiology
Chemical Substances	Immunologic Factors ; Tumor Necrosis Factor-alpha
Language	English
Publishing date	2011-09
Publishing country	Canada
Document type	Comparative Study ; Journal Article
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.101316
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Article ; Online: Economic evaluation of anti-epileptic drug therapies with specific focus on teratogenic outcomes.

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Article ; Online: Evaluation of the representativeness of a Dutch non-malformed control group for the general pregnant population: are these controls useful for EUROCAT?

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Article ; Online: Does folic acid use decrease the risk for spina bifida after in utero exposure to valproic acid?

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Article ; Online: Intrauterine exposure to carbamazepine and specific congenital malformations: systematic review and case-control study.

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Article ; Online: Valproic acid monotherapy in pregnancy and major congenital malformations.

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Article ; Online: Economic evaluation of folic acid food fortification in The Netherlands.

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Article: The distribution of congenital anomalies within the VACTERL association among tumor necrosis factor antagonist-exposed pregnancies is similar to the general population.

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