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Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services
A. Panchaud, V. Rousson, T. Vial, N. Bernard, D. Baud, E. Amar, M. De Santis, A. Pistelli, A. Dautriche, F. Beau-Salinas, M. Cassina, H. Dunstan, A. Passier, YC. Kaplan, MK. Duman, E. Maňáková, G. Eleftheriou, G. Klinger, U. Winterfeld, LE....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem
NLK
Free Medical Journals
od 1974 do 2020
PubMed Central
od 1974 do 2020
Europe PubMed Central
od 1974 do Před 1 rokem
Wiley Free Content
od 1997 do Před 1 rokem
PubMed
29215149
DOI
10.1111/bcp.13481
Knihovny.cz E-zdroje
- MeSH
- dospělí MeSH
- hypoglykemika aplikace a dávkování škodlivé účinky MeSH
- kohortové studie MeSH
- komplikace těhotenství farmakoterapie MeSH
- lidé MeSH
- metformin aplikace a dávkování škodlivé účinky MeSH
- narození mrtvého plodu epidemiologie MeSH
- prospektivní studie MeSH
- první trimestr těhotenství MeSH
- samovolný potrat epidemiologie MeSH
- těhotenství při diabetu farmakoterapie MeSH
- těhotenství MeSH
- výsledek těhotenství * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
AIMS: Metformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy. METHOD: We evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group. RESULTS: The risk of major birth defects was 5.1% (20/392) in pregnancies exposed to metformin during the first trimester and 2.1% (9/431) in the reference group [adjusted odds ratio (OR) 1.70; 95% CI 0.70-4.38]. Among metformin users, this risk was 7.8% (17/219) in patients with pre-gestational diabetes and 1.7% (3/173) in those without this diagnosis. Compared to the unexposed reference, the OR for metformin user with diabetes was 3.95 (95% CI 1.77-9.41) and for metformin with other indications it was 0.83 (95% CI 0.18-2.81). The risk of pregnancy losses (spontaneous abortions and stillbirths) was 20.8% in women on metformin during the first trimester and 10.8% in the reference group [adjusted hazard ratio (HR) 1.57; 95% CI 0.90-2.74]. The risks for women on metformin with and without pre-gestational diabetes were 24.0% and 16.8% respectively, with adjusted HR of 2.51 (95% CI 1.44-4.36) and 1.38 (95% CI 0.74-2.59) when compared to the reference. CONCLUSION: Pregnant women with pre-gestational diabetes on metformin are at a higher risk for adverse pregnancy outcomes than the general population. This appears to be due to the underlying diabetes since women on metformin for other indications do not present meaningfully increased risks.
CZTIS 3rd Faculty of Medicine Charles University Prague Czech Republic
Department of Epidemiology Harvard School of Public Health Boston Massachusetts USA
Faculty of Medicine Department of Pharmacology Karadeniz Technical University Trabzon Turkey
Pharmacovigilance Center of Dijon CHU Dijon France
Pharmacovigilance Center of Lyon Hospices Civils de Lyon France
Pharmacovigilance Center of Tours CHRU Tours France
Poison Control Center Bergamo Italy
Registre des Malformations en Rhone Alpes Faculté Laennec Lyon France
School of Pharmaceutical Sciences University of Geneva and Lausanne Geneva Switzerland
Teratology Information Service Netherlands Pharmacovigilance Centre Lareb The Netherlands
UKTIS Regional Drug and Therapeutics Centre Newcastle upon Tyne UK
Citace poskytuje Crossref.org
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- $a Panchaud, Alice $u School of Pharmaceutical Sciences, University of Geneva and Lausanne, Geneva, Switzerland. Swiss Teratogen Information Service (STIS) and Service of Clinical Pharmacology, University Hospital, Lausanne, Switzerland. Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.
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- $a Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services / $c A. Panchaud, V. Rousson, T. Vial, N. Bernard, D. Baud, E. Amar, M. De Santis, A. Pistelli, A. Dautriche, F. Beau-Salinas, M. Cassina, H. Dunstan, A. Passier, YC. Kaplan, MK. Duman, E. Maňáková, G. Eleftheriou, G. Klinger, U. Winterfeld, LE. Rothuizen, T. Buclin, C. Csajka, S. Hernandez-Diaz,
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- $a AIMS: Metformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy. METHOD: We evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group. RESULTS: The risk of major birth defects was 5.1% (20/392) in pregnancies exposed to metformin during the first trimester and 2.1% (9/431) in the reference group [adjusted odds ratio (OR) 1.70; 95% CI 0.70-4.38]. Among metformin users, this risk was 7.8% (17/219) in patients with pre-gestational diabetes and 1.7% (3/173) in those without this diagnosis. Compared to the unexposed reference, the OR for metformin user with diabetes was 3.95 (95% CI 1.77-9.41) and for metformin with other indications it was 0.83 (95% CI 0.18-2.81). The risk of pregnancy losses (spontaneous abortions and stillbirths) was 20.8% in women on metformin during the first trimester and 10.8% in the reference group [adjusted hazard ratio (HR) 1.57; 95% CI 0.90-2.74]. The risks for women on metformin with and without pre-gestational diabetes were 24.0% and 16.8% respectively, with adjusted HR of 2.51 (95% CI 1.44-4.36) and 1.38 (95% CI 0.74-2.59) when compared to the reference. CONCLUSION: Pregnant women with pre-gestational diabetes on metformin are at a higher risk for adverse pregnancy outcomes than the general population. This appears to be due to the underlying diabetes since women on metformin for other indications do not present meaningfully increased risks.
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