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Article ; Online: The addition of the sFlt-1/PlGF ratio to the protein/creatinine ratio in multiple pregnancy: Post-hoc analysis of the PREPARE cohort study.

Wind, M / Dekker, L / van den Akker-van Marle, M E / Ballieux, B E P B / Cobbaert, C M / Rabelink, T J / van Lith, J M M / Teng, Y K O / Sueters, M

Pregnancy hypertension

2024 Volume 36, Page(s) 101111

Abstract: Objective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with suspected pre-eclampsia.: Study design: Post-hoc ... ...

Abstract	Objective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with suspected pre-eclampsia. Study design: Post-hoc analysis of a prospective cohort study. Main outcome measures: Primary outcome was the occurrence of pre-eclampsia in one and four weeks after presentation with suspected pre-eclampsia. Test characteristics with 95% confidence intervals (CI) were calculated on pre-eclampsia development in one and four weeks. Results: Twenty-three multiple pregnancies with suspected pre-eclampsia between 20 and 37 weeks gestation were included for analysis. Women who eventually developed pre-eclampsia had a significantly higher PCr (34.0 vs. 16.5, p = 0.015), sFlt-1 (17033 vs. 5270 pg/ml, p = 0.047) and sFlt-1/PlGF ratio (99 vs. 25, p = 0.033) at baseline. Furthermore, PCr ≥ 30 and sFlt-1/PlGF ratio > 38 was respectively seen in 1/16 (6.3 %) and 3/16 (18.8 %) of the women who did not develop pre-eclampsia. For predicting pre-eclampsia within one week the sFlt-1/PlGF ratio sensitivity was 75.0 % [95 % CI 19.4-99.4] and the negative predictive value 93.8 % [73.0-98.8], while no pre-eclampsia developed when PCr was < 30. Consequently, the combination of these tests did not lead to an improvement in test characteristics, with non-significant differences in positive predictive value (50.0 % [29.5-70.5] versus 80.0 % [37.3-96.4]) compared to PCr alone for pre-eclampsia development in one week. Conclusions: In addition to standard-of-care spot urine PCr measurements, this study has not been able to demonstrate that the sFlt-1/PlGF ratio cut-off 38 is of added value in the prediction of pre-eclampsia in multiple pregnancy. Trial registration: Netherlands Trial Register (NL8308).
Language	English
Publishing date	2024-02-21
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2584464-7
ISSN	2210-7797 ; 2210-7789
ISSN (online)	2210-7797
ISSN	2210-7789
DOI	10.1016/j.preghy.2024.101111
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Article ; Online: Clinical value and cost analysis of the sFlt-1/PlGF ratio in addition to the spot urine protein/creatinine ratio in women with suspected pre-eclampsia: PREPARE cohort study.

Wind, M / van den Akker-van Marle, M E / Ballieux, B E P B / Cobbaert, C M / Rabelink, T J / van Lith, J M M / Teng, Y K O / Sueters, M

BMC pregnancy and childbirth

2022 Volume 22, Issue 1, Page(s) 910

Abstract: Background: This study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia.: Methods: This was a prospective cohort study performed in a tertiary ... ...

Abstract	Background: This study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia. Methods: This was a prospective cohort study performed in a tertiary referral centre. Based on the combination of PCr (< 30) and sFlt-1/PlGF (≤38) results, four groups were described: a double negative result, group A-/-; a negative PCr and positive sFlt-1/PlGF, group B-/+; a positive PCr and negative sFlt-1/PlGF, group C+/-; and a double positive result, group D+/+. The primary outcome was the proportion of false negatives of the combined tests in comparison with PCr alone in the first week after baseline. Secondary, a cost analysis comparing the costs and savings of adding the sFlt-1/PlGF ratio was performed for different follow-up scenarios. Results: A total of 199 women were included. Pre-eclampsia in the first week was observed in 2 women (2%) in group A-/-, 12 (26%) in group B-/+, 4 (27%) in group C+/-, and 12 (92%) in group D+/+. The proportion of false negatives of 8.2% [95% CI 4.9-13.3] with the PCr alone was significantly reduced to 1.6% [0.4-5.7] by adding a negative sFlt-1/PlGF ratio. Furthermore, the addition of the sFlt-1/PlGF ratio to the spot urine PCr, with telemonitoring of women at risk, could result in a reduction of 41% admissions and 36% outpatient visits, leading to a cost reduction of €46,- per patient. Conclusions: Implementation of the sFlt-1/PlGF ratio in addition to the spot urine PCr, may lead to improved selection of women at low risk and a reduction of hospital care for women with suspected pre-eclampsia. Trial registration: Netherlands Trial Register (NL8308).
MeSH term(s)	Female ; Humans ; Pre-Eclampsia/diagnosis ; Cohort Studies ; Prospective Studies ; Netherlands ; Costs and Cost Analysis
Language	English
Publishing date	2022-12-06
Publishing country	England
Document type	Journal Article
ZDB-ID	2059869-5
ISSN	1471-2393 ; 1471-2393
ISSN (online)	1471-2393
ISSN	1471-2393
DOI	10.1186/s12884-022-05254-1
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Article ; Online: IGF-1 and IGF-1 SDS - fit for purpose?

Kos, S / Cobbaert, C M / Kuijper, T M / Oostdijk, W / Hannema, S E / Wit, J M / Biermasz, N / Ballieux, B E P B

European journal of endocrinology

2019 Volume 181, Issue 5, Page(s) L1–L4

MeSH term(s)	Adolescent ; Adult ; Aged ; Biomarkers/blood ; Child ; Child, Preschool ; Female ; Humans ; Insulin-Like Growth Factor I/metabolism ; Male ; Middle Aged ; Reference Standards ; Young Adult
Chemical Substances	Biomarkers ; IGF1 protein, human ; Insulin-Like Growth Factor I (67763-96-6)
Language	English
Publishing date	2019-09-04
Publishing country	England
Document type	Letter
ZDB-ID	1183856-5
ISSN	1479-683X ; 0804-4643
ISSN (online)	1479-683X
ISSN	0804-4643
DOI	10.1530/EJE-19-0458
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Article ; Online: Failing hormones.

Opdam, F L / Ballieux, B E P B / Guchelaar, H / Pereira, A M

The Netherlands journal of medicine

2011 Volume 69, Issue 11, Page(s) 528, 532

MeSH term(s)	Aged ; Cushing Syndrome/diagnosis ; Cushing Syndrome/etiology ; Diabetes Mellitus, Type 2/complications ; Female ; Humans ; Hypoaldosteronism/diagnosis ; Hypoaldosteronism/etiology ; Prednisone/adverse effects
Chemical Substances	Prednisone (VB0R961HZT)
Language	English
Publishing date	2011-11
Publishing country	Netherlands
Document type	Case Reports ; Journal Article
ZDB-ID	193149-0
ISSN	1872-9061 ; 0300-2977
ISSN (online)	1872-9061
ISSN	0300-2977
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Article ; Online: Bisphosphonate dose and incidence of fractures in postmenopausal osteoporosis.

Makras, P / Hamdy, N A T / Zwinderman, A H / Ballieux, B E P B / Papapoulos, S E

Bone

2009 Volume 44, Issue 5, Page(s) 766–771

Abstract: Introduction: The specific pharmacological properties of bisphosphonates have raised concerns about their long-term effects on skeletal fragility that may be related to the total dose of bisphosphonate given. However, the effect of different doses on ... ...

Abstract	Introduction: The specific pharmacological properties of bisphosphonates have raised concerns about their long-term effects on skeletal fragility that may be related to the total dose of bisphosphonate given. However, the effect of different doses on the incidence of osteoporotic fractures has not been adequately studied. Methods: In this retrospective analysis, we investigated the effect of different doses of intravenous pamidronate given at 3-monthly intervals on the incidence of fractures in 92 women with severe postmenopausal osteoporosis. Results: The risk of sustaining a new vertebral fracture on treatment was significantly increased by 32% for every prevalent vertebral fracture (OR: 1.32, CI: 1.05, 1.66; p=0.02). Patients with nonvertebral fractures received a significantly lower dose of pamidronate and their risk for these fractures increased by 25% for every prevalent vertebral fracture at baseline (OR: 1.25, CI: 1.01, 1.53; p=0.03). Patients who had received oral bisphosphonate before intravenous pamidronate had a significantly higher incidence of nonvertebral fractures which, however, did not hold true after adjustment for baseline BMD and prevalent fractures. Conclusions: In patients with established osteoporosis bone fragility during treatment with intravenous pamidronate is mainly determined by the severity of the disease, assessed by the presence and numbers of prevalent fractures, rather than the dose of the bisphosphonate or the rate of bone turnover.
MeSH term(s)	Aged ; Bone Density/drug effects ; Bone Density Conservation Agents/therapeutic use ; Diphosphonates/administration & dosage ; Diphosphonates/therapeutic use ; Drug Administration Schedule ; Female ; Fractures, Bone/epidemiology ; Fractures, Bone/etiology ; Fractures, Bone/prevention & control ; Humans ; Osteoporosis, Postmenopausal/complications ; Osteoporosis, Postmenopausal/drug therapy ; Retrospective Studies
Chemical Substances	Bone Density Conservation Agents ; Diphosphonates
Language	English
Publishing date	2009-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	632515-4
ISSN	1873-2763 ; 8756-3282
ISSN (online)	1873-2763
ISSN	8756-3282
DOI	10.1016/j.bone.2009.01.371
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Article ; Online: IGSF1 Deficiency: Lessons From an Extensive Case Series and Recommendations for Clinical Management.

Joustra, S D / Heinen, C A / Schoenmakers, N / Bonomi, M / Ballieux, B E P B / Turgeon, M-O / Bernard, D J / Fliers, E / van Trotsenburg, A S P / Losekoot, M / Persani, L / Wit, J M / Biermasz, N R / Pereira, A M / Oostdijk, W

The Journal of clinical endocrinology and metabolism

2016 Volume 101, Issue 4, Page(s) 1627–1636

Abstract: Context: Mutations in the immunoglobulin superfamily, member 1 (IGSF1) gene cause the X-linked IGSF1 deficiency syndrome consisting of central hypothyroidism, delayed pubertal testosterone rise, adult macroorchidism, variable prolactin deficiency, and ... ...

Abstract	Context: Mutations in the immunoglobulin superfamily, member 1 (IGSF1) gene cause the X-linked IGSF1 deficiency syndrome consisting of central hypothyroidism, delayed pubertal testosterone rise, adult macroorchidism, variable prolactin deficiency, and occasionally transient partial GH deficiency. Since our first reports, we discovered 20 new families with 18 new pathogenic IGSF1 mutations. Objective: We aimed to share data on the largest cohort of patients with IGSF1 deficiency to date and formulate recommendations for clinical management. Methods: We collected clinical and biochemical characteristics of 69 male patients (35 children, 34 adults) and 56 female IGSF1 mutation carriers (three children, 53 adults) from 30 unrelated families according to a standardized clinical protocol. At evaluation, boys were treated with levothyroxine in 89%, adult males in 44%, and females in 5% of cases. Results: Additional symptoms in male patients included small thyroid gland volume (74%), high birth weight (25%), and large head circumference (20%). In general, the timing of pubertal testicular growth was normal or even premature, in contrast to a late rise in T levels. Late adrenarche was observed in patients with prolactin deficiency, and adult dehydroepiandrosterone concentrations were decreased in 40%. Hypocortisolism was observed in 6 of 28 evaluated newborns, although cortisol concentrations were normal later. Waist circumference of male patients was increased in 60%, but blood lipids were normal. Female carriers showed low free T4 (FT4) and low-normal FT4 in 18% and 60%, respectively, delayed age at menarche in 31%, mild prolactin deficiency in 22%, increased waist circumference in 57%, and a negative correlation between FT4 concentrations and metabolic parameters. Conclusion: IGSF1 deficiency represents the most common genetic cause of central hypothyroidism and is associated with multiple other characteristics. Based on these results, we provide recommendations for mutational analysis, endocrine work-up, and long-term care.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Attention Deficit Disorder with Hyperactivity/genetics ; Child ; Child, Preschool ; Female ; Genetic Diseases, X-Linked/drug therapy ; Genetic Diseases, X-Linked/genetics ; Humans ; Hypothyroidism/drug therapy ; Hypothyroidism/genetics ; Immunoglobulins/deficiency ; Immunoglobulins/genetics ; Infant ; Male ; Membrane Proteins/deficiency ; Membrane Proteins/genetics ; Middle Aged ; Neuropsychological Tests ; Practice Guidelines as Topic/standards ; Quality of Life ; Syndrome ; Thyroxine/therapeutic use ; Young Adult
Chemical Substances	IGSF1 protein, human ; Immunoglobulins ; Membrane Proteins ; Thyroxine (Q51BO43MG4)
Language	English
Publishing date	2016-02-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3029-6
ISSN	1945-7197 ; 0021-972X
ISSN (online)	1945-7197
ISSN	0021-972X
DOI	10.1210/jc.2015-3880
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Article ; Online: Thyroid function, activated protein C resistance and the risk of venous thrombosis in users of hormonal contraceptives.

Raps, M / Curvers, J / Helmerhorst, F M / Ballieux, B E P B / Rosing, J / Thomassen, S / Rosendaal, F R / van Vliet, H A A M

Thrombosis research

2014 Volume 133, Issue 4, Page(s) 640–644

Abstract: Introduction: Use of combined hormonal contraceptives is associated with a three- to eight-fold increased risk of venous thrombosis compared with non-use. The thrombotic risk depends on the estrogen dose as well as the progestogen type. Use of hormonal ... ...

Abstract	Introduction: Use of combined hormonal contraceptives is associated with a three- to eight-fold increased risk of venous thrombosis compared with non-use. The thrombotic risk depends on the estrogen dose as well as the progestogen type. Use of hormonal contraceptives leads to resistance to activated protein C (APC), which may serve as marker for the risk of venous thrombosis. Hyperthyroidism is also associated with an increased risk of venous thrombosis, due to increased free Thyroxine (FT4) levels which cause a hypercoagulable state. Materials and methods: The objective of this study was to evaluate the effects of hormonal contraceptives on levels of FT4, thyroid stimulating hormone (TSH) and thyroxine binding globulin (TBG), and to investigate the effects on APC resistance per contraceptive group. We measured FT4, TBG and TSH levels and APC resistance in 231 users of oral contraceptives. Results: Users of the most thrombogenic hormonal contraceptives, i.e. containing desogestrel, cyproterone acetate or drospirenone, had higher TBG levels than users of less thrombogenic hormonal contraceptives, i.e. the levonorgestrel-containing intrauterine device. TSH levels were not significantly elevated and FT4 levels did not change. TBG levels were also associated with APC resistance. Conclusion: Use of hormonal contraceptives lead to elevated TBG levels, slightly elevated TSH levels and unchanged FT4 levels without causing a hyperthyroid state. Thus, the increased thrombotic risk during the use of hormonal contraceptives cannot be explained by a hyperthyroid state caused by use of these hormonal contraceptives.
MeSH term(s)	Activated Protein C Resistance/blood ; Activated Protein C Resistance/chemically induced ; Adolescent ; Adult ; Contraceptive Devices, Female ; Contraceptives, Oral/administration & dosage ; Contraceptives, Oral/adverse effects ; Contraceptives, Oral, Combined/adverse effects ; Contraceptives, Oral, Hormonal/adverse effects ; Cross-Over Studies ; Female ; Humans ; Intrauterine Devices, Copper/adverse effects ; Intrauterine Devices, Medicated/adverse effects ; Middle Aged ; Randomized Controlled Trials as Topic ; Thyroid Gland/drug effects ; Thyrotropin/blood ; Thyroxine/blood ; Thyroxine-Binding Globulin/metabolism ; Venous Thrombosis/blood ; Venous Thrombosis/chemically induced ; Young Adult
Chemical Substances	Contraceptives, Oral ; Contraceptives, Oral, Combined ; Contraceptives, Oral, Hormonal ; Thyroxine-Binding Globulin ; Thyrotropin (9002-71-5) ; Thyroxine (Q51BO43MG4)
Language	English
Publishing date	2014-04
Publishing country	United States
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2013.12.041
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Article ; Online: Pharmacokinetics and pharmacodynamics of orally administered clonidine: a model-based approach.

Klein, R H / Alvarez-Jimenez, R / Sukhai, R N / Oostdijk, W / Bakker, B / Reeser, H M / Ballieux, B E P B / Hu, P / Klaassen, E S / Freijer, J / Burggraaf, J / Cohen, A F / Wit, J M

Hormone research in paediatrics

2013 Volume 79, Issue 5, Page(s) 300–309

Abstract: Background/aims: The oral clonidine test is a diagnostic procedure performed in children with suspected growth hormone (GH) deficiency. It is associated with untoward effects, including bradycardia, hypotension and sedation. Serum clonidine levels have ... ...

Abstract	Background/aims: The oral clonidine test is a diagnostic procedure performed in children with suspected growth hormone (GH) deficiency. It is associated with untoward effects, including bradycardia, hypotension and sedation. Serum clonidine levels have not previously been assessed during this test. Methods: In 40 children referred for an oral clonidine test, blood samples were drawn for clonidine and GH. Vital statistics and sedation scores were recorded until 210 min post-dose. We explored the relationship between clonidine concentrations and effects such as GH peak and blood pressure. Results: Of 40 participants, 5 children were GH deficient. Peak clonidine concentrations of 0.846 ± 0.288 ng/ml were reached after 1 h. Serum levels declined slowly, with concentrations of 0.701 ± 0.189 ng/ml 210 min post-dose. A large interindividual variation of serum levels was observed. During the procedure, systolic blood pressure dropped by 12.8%, diastolic blood pressure by 19.7% and heart rate by 8.4%. Moderate sedation levels were observed. Concentration-effect modeling showed that the amount of GH available for secretion as determined by previous bursts was an important factor influencing GH response. Conclusion: Clonidine concentrations during the test were higher than necessary according to model-based predictions. A lower clonidine dose may be sufficient and may produce fewer side effects.
MeSH term(s)	Administration, Oral ; Adolescent ; Child ; Child, Preschool ; Clonidine/administration & dosage ; Clonidine/pharmacokinetics ; Female ; Human Growth Hormone/blood ; Human Growth Hormone/deficiency ; Humans ; Male ; Models, Biological ; Sympatholytics/administration & dosage ; Sympatholytics/pharmacokinetics ; Time Factors
Chemical Substances	Sympatholytics ; Human Growth Hormone (12629-01-5) ; Clonidine (MN3L5RMN02)
Language	English
Publishing date	2013
Publishing country	Switzerland
Document type	Clinical Trial ; Journal Article
ZDB-ID	2537278-6
ISSN	1663-2826 ; 1663-2818
ISSN (online)	1663-2826
ISSN	1663-2818
DOI	10.1159/000350819
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Article ; Online: Sex hormone-binding globulin as a marker for the thrombotic risk of hormonal contraceptives: reply to a rebuttal.

Raps, M / Helmerhorst, F M / Fleischer, K / van Hylckama Vlieg, A / Van Hylckama, V A / Stegeman, B H / Thomassen, S / Rosendaal, F R / Rosing, J / Ballieux, B E P B / Van Vliet, H A A M

Journal of thrombosis and haemostasis : JTH

2012 Volume 11, Issue 2, Page(s) 396–397

MeSH term(s)	Blood Coagulation/drug effects ; Contraceptive Agents, Female/adverse effects ; Female ; Humans ; Sex Hormone-Binding Globulin/metabolism ; Venous Thrombosis/chemically induced
Chemical Substances	Contraceptive Agents, Female ; Sex Hormone-Binding Globulin
Language	English
Publishing date	2012-11-19
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	2112661-6
ISSN	1538-7836 ; 1538-7933
ISSN (online)	1538-7836
ISSN	1538-7933
DOI	10.1111/jth.12080
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Article: Pharmacokinetics and Pharmacodynamics of Orally Administered Clonidine: A Model-Based Approach

Klein, R.H. / Alvarez-Jimenez, R. / Sukhai, R.N. / Oostdijk, W. / Bakker, B. / Reeser, H.M. / Ballieux, B.E.P.B. / Hu, P. / Klaassen, E.S. / Freijer, J. / Burggraaf, J. / Cohen, A.F. / Wit, J.M.

Hormone Research in Paediatrics

2013 Volume 79, Issue 5, Page(s) 300–309

Abstract: Background/Aims: The oral clonidine test is a diagnostic procedure performed in children with suspected growth hormone (GH) deficiency. It is associated with untoward effects, including bradycardia, hypotension and sedation. Serum clonidine levels have ... ...

Institution	Centre for Human Drug Research, and Departments of Paediatrics and Clinical Chemistry, Leiden University Medical Center, Leiden Department of Paediatrics, Reinier de Graaf Groep, Delft, and Haga Hospital/Juliana's Children's Hospital, The Hague, The Netherlands Clinical Pharmacology Research Center at Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, Beijing, China
Abstract	Background/Aims: The oral clonidine test is a diagnostic procedure performed in children with suspected growth hormone (GH) deficiency. It is associated with untoward effects, including bradycardia, hypotension and sedation. Serum clonidine levels have not previously been assessed during this test. Methods: In 40 children referred for an oral clonidine test, blood samples were drawn for clonidine and GH. Vital statistics and sedation scores were recorded until 210 min post-dose. We explored the relationship between clonidine concentrations and effects such as GH peak and blood pressure. Results: Of 40 participants, 5 children were GH deficient. Peak clonidine concentrations of 0.846 ± 0.288 ng/ml were reached after 1 h. Serum levels declined slowly, with concentrations of 0.701 ± 0.189 ng/ml 210 min post-dose. A large interindividual variation of serum levels was observed. During the procedure, systolic blood pressure dropped by 12.8%, diastolic blood pressure by 19.7% and heart rate by 8.4%. Moderate sedation levels were observed. Concentration-effect modeling showed that the amount of GH available for secretion as determined by previous bursts was an important factor influencing GH response. Conclusion: Clonidine concentrations during the test were higher than necessary according to model-based predictions. A lower clonidine dose may be sufficient and may produce fewer side effects.
Keywords	Clonidine ; Child ; Growth hormone provocative testing ; Diagnosis ; Growth hormone deficiency ; Pharmacokinetics
Language	English
Publishing date	2013-05-31
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Original Paper
ZDB-ID	2537278-6
ISSN	1663-2826 ; 1663-2818
ISSN (online)	1663-2826
ISSN	1663-2818
DOI	10.1159/000350819
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