Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes

Castillo, Wendy Camelo; Boggess, Kim; Stürmer, Til; Brookhart, M. Alan; Benjamin, Daniel K.; Funk, Michele Jönsson

doi:10.1001/jamapediatrics.2015.74

Cited by 128 publications

(58 citation statements)

References 26 publications

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“…Where possible, we linked mothers to offspring by identifying newborns within the same insurance plan family grouping with birth coding (ICD-9-CM codes V30-V37) within 7 days of the mother’s delivery code to account for slight differences in billing and enrollment timing between the mother and child[14, 20, 21]; linkage was not possible if the mothers and newborns were covered by different insurance plans. We estimated gestational age at delivery by imputing standard ages based on delivery prematurity or post-term delivery diagnoses codes from the mother and linked child.…”

Section: Methodsmentioning

confidence: 99%

Prenatal Tdap immunization and risk of maternal and newborn adverse events

Layton¹,

Butler

Li³

et al. 2017

Vaccine

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Many countries recommend combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis immunization (Tdap) during pregnancy to stimulate transplacental transmission of pertussis antibodies to newborns. The immune system can be altered during pregnancy, potentially resulting in differing immunization risks in pregnant women. The safety of widespread Tdap immunization during pregnancy needs to be established. Our objective was to assess whether prenatal Tdap immunization was associated with adverse birth outcomes, and to evaluate the effect of timing of Tdap administration on these outcomes. We identified pregnancies at delivery in a large insurance claims database (2010–2014). Tdap immunization was categorized as optimal prenatal (27+ weeks), early prenatal (<27 weeks), postpartum (≤7 days post-delivery), or none. Medical claims were searched to identify maternal adverse immunization reactions (e.g. anaphylaxis, fever, Guillian-Barre syndrome [GBS]), adverse birth outcomes (e.g. preeclampsia/eclampsia, premature rupture or membranes, chorioamnionitis) and newborn outcomes (e.g. respiratory distress, pulmonary hypertension, neonatal jaundice). Women with optimal or early prenatal Tdap were compared to those not immunized in pregnancy, using propensity score-weighted log-binomial regression and Cox proportional hazards models to estimate risk ratios (RR) and hazard ratios (HR). We identified 1,079,034 deliveries and 677,075 linked newborns; 11.5% were immunized optimally and 2.3% immunized early. There were 1 case of post-immunization anaphylaxis, and 12 cases of maternal encephalopathy (all post-delivery); there were no cases of GBS. Optimally-timed immunization was associated with small increased relative risks of: chorioamnionitis [RR=1.11, (95% CI: 1.07–1.15), overall risk=2.8%], and postpartum hemorrhage [RR=1.23 (95% DI: 1.18–1.28), overall risk=2.4%]; however, these relative increases corresponded to low absolute risk increases. Tdap was not associated with increased risk of any adverse newborn outcome. Overall, prenatal Tdap immunization was not associated with newborn adverse events, but potential associations with chorioamnionitis consistent with one previous study and postpartum hemorrhage require further investigation.

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Section: Methodsmentioning

confidence: 99%

Prenatal Tdap immunization and risk of maternal and newborn adverse events

Layton¹,

Butler

Li³

et al. 2017

Vaccine

View full text Add to dashboard Cite

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“…Glyburide was associated with higher rates of pre-eclampsia and need for phototherapy in infants, but fewer infants from the glyburide group were admitted to NICU 77. In contrast, a retrospective cohort study comparing outcomes in 4982 women treated with glyburide and 4191 women treated with insulin found that glyburide treatment was associated with increased risk of NICU admission, respiratory distress, hypoglycemia, birth injury, and LGA birth weight 78. This study was limited by the lack of information on glycemic control or maternal body mass index.…”

Section: Glyburidementioning

confidence: 96%

Novel therapies for diabetes mellitus in pregnancy

Feghali

Scifres

2018

BMJ

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Diabetes is a common complication of pregnancy, and the prevalence of all types of the disease is increasing worldwide. Diabetes in pregnancy is associated with short term and long term adverse effects for mother and child. The goal of treatment of diabetes in pregnancy is to minimize maternal and fetal adverse events related to hyperglycemia. Treatment options vary by type of diabetes, from a focus on lifestyle modifications in gestational diabetes to continuous glucose monitoring and insulin pumps in pregestational diabetes. Nevertheless, given the commonality of hyperglycemia, considerable overlap exists in the treatment of different types of diabetes in pregnancy. Also, despite ongoing research on treatment of diabetes in pregnancy for decades, changes in the characteristics of the patient population have highlighted the limited effectiveness of different therapies. Specifically, despite the co-occurrence of obesity and diabetes, treatment recommendations including glycemic targets are not altered in such cases and a single optimal treatment strategy for each type of diabetes in pregnancy does not seem to exist. Rather, the approach to treating pregnant women with diabetes likely needs to be individualized to maximize the short term and long term health of mother and child. This article will review recent clinical studies to summarize established treatment strategies and introduce novel therapies for diabetes in pregnancy.

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“…An additional study in 2073 women also found higher odds of neonatal intensive care admission (adjusted odds ratio 1.46, 95%CI 1.07–2.00) and birth weight >4000 g (adjusted odds ratio 1.29, 95% CI 1.03–1.64) amongst infants born to mothers receiving glibenclamide during pregnancy 27. The evidence now indicates that glibenclamide treatment in the third trimester exacerbates fetal hyperinsulinism in utero and has an additive effect on birth weight 10, 26, 28. These studies have raised concern regarding the use of glibenclamide in pregnancy 25.…”

Section: Sulfonylurea Treatment In Pregnancy In Type 2 Diabetes and Gmentioning

confidence: 99%

“…More recent publications have demonstrated an increased risk of obstetric and neonatal complications with sulfonylurea use. Even though good glycaemic control may be maintained, pregnant women with GDM treated with glibenclamide had larger babies than insulin‐treated mothers, further increasing the risk of obstetric and neonatal complications from macrosomia 25, 26. In a meta‐analysis of randomized controlled trials, glibenclamide use resulted in greater birth weight (mean difference 109 g; 95% CI 36–181), and higher risks of macrosomia [risk ratio (RR) 2.62, 95% CI 1.35–5.08) and fetal hypoglycaemia (RR 2.04, 95% CI 1.30–3.20) 10.…”

Section: Sulfonylurea Treatment In Pregnancy In Type 2 Diabetes and Gmentioning

confidence: 99%

“…In a meta‐analysis of randomized controlled trials, glibenclamide use resulted in greater birth weight (mean difference 109 g; 95% CI 36–181), and higher risks of macrosomia [risk ratio (RR) 2.62, 95% CI 1.35–5.08) and fetal hypoglycaemia (RR 2.04, 95% CI 1.30–3.20) 10. In a large cohort study from the USA in 110 000 women with GDM, newborns of women treated with glibenclamide (glyburide) were at higher risk of neonatal intensive care unit admission (RR 1.41; 95% CI 1.23–1.62), respiratory distress (RR 1.63; 95% CI 1.23–2.15), hypoglycaemia (RR 1.40; 95% CI 1.00–1.95), birth injury (RR 1.35; 95% CI 1.00–1.82), and large for gestational age (RR 1.43, 95% CI 1.16–1.76) compared with those treated with insulin 26. An additional study in 2073 women also found higher odds of neonatal intensive care admission (adjusted odds ratio 1.46, 95%CI 1.07–2.00) and birth weight >4000 g (adjusted odds ratio 1.29, 95% CI 1.03–1.64) amongst infants born to mothers receiving glibenclamide during pregnancy 27.…”

Section: Sulfonylurea Treatment In Pregnancy In Type 2 Diabetes and Gmentioning

confidence: 99%

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Management of sulfonylurea‐treated monogenic diabetes in pregnancy: implications of placental glibenclamide transfer

et al. 2017

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The optimum treatment for HNF1A/HNF4A maturity‐onset diabetes of the young and ATP‐sensitive potassium (KATP) channel neonatal diabetes, outside pregnancy, is sulfonylureas, but there is little evidence regarding the most appropriate treatment during pregnancy. Glibenclamide has been widely used in the treatment of gestational diabetes, but recent data have established that glibenclamide crosses the placenta and increases risk of macrosomia and neonatal hypoglycaemia. This raises questions about its use in pregnancy. We review the available evidence and make recommendations for the management of monogenic diabetes in pregnancy. Due to the risk of stimulating increased insulin secretion in utero, we recommend that in women with HNF1A/ HNF4A maturity‐onset diabetes of the young, those with good glycaemic control who are on a sulfonylurea per conception either transfer to insulin before conception (at the risk of a short‐term deterioration of glycaemic control) or continue with sulfonylurea (glibenclamide) treatment in the first trimester and transfer to insulin in the second trimester. Early delivery is needed if the fetus inherits an HNF4A mutation from either parent because increased insulin secretion results in ~800‐g weight gain in utero, and prolonged severe neonatal hypoglycaemia can occur post‐delivery. If the fetus inherits a KATP neonatal diabetes mutation from their mother they have greatly reduced insulin secretion in utero that reduces fetal growth by ~900 g. Treating the mother with glibenclamide in the third trimester treats the affected fetus in utero, normalising fetal growth, but is not desirable, especially in the high doses used in this condition, if the fetus is unaffected. Prospective studies of pregnancy in monogenic diabetes are needed.

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Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes

Cited by 128 publications

References 26 publications

Prenatal Tdap immunization and risk of maternal and newborn adverse events

Prenatal Tdap immunization and risk of maternal and newborn adverse events

Novel therapies for diabetes mellitus in pregnancy

Management of sulfonylurea‐treated monogenic diabetes in pregnancy: implications of placental glibenclamide transfer

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