The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.
The need for appropriate registration of pregnancy outcomes under newer oral glucose-lowering therapies
Open accessAbstract
Because of the increase in type 2 diabetes (T2DM) in young adults, women of childbearing age are frequently treated with newer glucose‐lowering therapies, and an increase in unintentional exposure to therapies unapproved for use during pregnancy is expected. The clinician is left with the dilemma of deciding between discontinuation of a novel agent that is providing excellent glycaemic control, while switching to other agents may cause deterioration of glycaemia, and continued use of novel agents that may have uncertain effects on the unborn child. For T2DM, pregnancy data are collected only via spontaneous reporting systems. Therefore, we evaluated the available data on pregnancy outcomes under newer glucose‐lowering agents in pharmaceutical safety databases. We found that data on pregnancy outcomes with new glucose‐lowering agents in T2DM are scarce, with a high risk of bias towards negative outcomes, limiting their usefulness in robustly assessing safety. Because of the lack of information at present, these agents are not recommended for use during pregnancy or when planning pregnancy. To better guide clinical practice, structured systems of assessing pregnancy outcomes in women receiving these novel agents are urgently needed.
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In a pharmaceutical company safety database, canagliflozin, empagliflozin and dapagliflozin pregnancies were reported with outcomes including congenital anomalies, abortions, fetal demise, and normal live births.
“Furthermore, a study describing the data in the pharmaceutical company safety databases on pregnant women exposed to glucose lowering drugs including SGLT2 inhibitors was found (46). For Canagliflozin 29 pregnancies were reported of which 14 listed the corresponding pregnancy outcomes:1 congenital anomaly, 2 abortions, 1 fetal demise, 8 normal live births, 2 ongoing pregnancies. For Empagliflozin”
From Effects of GLP-1 agonists and SGLT2 inhibitors during pregnancy and lactation on offspring outcomes: a systematic review of the evidence (2023) · cites this paper as [46]
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Metformin in Gestational Diabetes: The Offspring Follow-Up (MiG TOFU)
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Insulin analogues in type 1 diabetes mellitus: Getting better all the time
Mathieu, C., Gillard, P., & Benhalima, K. (2017) · Nature Reviews Endocrinology · doi:10.1038/nrendo.2017.39 · Cited by 248
Self-citationMetformin vs insulin in the management of gestational diabetes: a meta-analysis
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The use of oral hypoglycaemic agents in pregnancy
Holt, R. I. G., & Lambert, K. (2013) · Diabetic Medicine · doi:10.1111/dme.12376 · Cited by 53
The experiences of prepregnancy care for women with type 2 diabetes mellitus: a meta-synthesis
Forde, R., Patelarou, E., & Forbes, A. (2016) · International Journal of Women s Health · doi:10.2147/ijwh.s115955 · Cited by 39
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Muller, D. R. P., Stenvers, D. J., Malekzadeh, A., Holleman, F., Painter, R. C., & Siegelaar, S. E. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1215356 · Cited by 174
Metadata
- Authors
- Benhalima, K., Mathiesen, E. R., Paldanius, P. M., & Mathieu, C.
- Affiliations
- Universitair Ziekenhuis Leuven (BE)
- University of Copenhagen (DK)
- Novartis Pharma AG Basel Switzerland
- Corresponding author
- Benhalima, Katrien
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2018-06-20
- Volume
- 20
- Issue
- 10
- Pages
- 2477-2480
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W2807429818
- Cited by
- 4
- References
- 12
- Citations by year
- 2026: 2 · 2025: 1 · 2023: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- green
- lirias.kuleuven.be
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion, other-oa)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Funders
- Clinical Doctoral Scholarship of the academic fund of UZ Leuven
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 2 diabetes, pregnancy outcomes, oral glucose-lowering agents, drug safety in pregnancy, spontaneous reporting systems, risk of bias, glycemic control, pregnancy planning
- MeSH terms
- Administration, Oral, Adult, Diabetes Mellitus, Type 2, Female, Health Services Needs and Demand, Humans, Hypoglycemic Agents, Infant, Newborn, Pregnancy, Pregnancy in Diabetics, Pregnancy Outcome, Research Design, Drugs, Investigational, Databases, Factual, Adverse Drug Reaction Reporting Systems
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