A Comparison of Glyburide and Insulin in Women with Gestational Diabetes Mellitus

Langer, Oded; Conway, Deborah L.; Berkus, Michael D.; Xenakis, Elly; Gonzales, Olga

doi:10.1056/nejm200010193431601

Cited by 819 publications

(481 citation statements)

References 38 publications

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“…Glibenclamide has until recently been considered a safe drug to use in pregnancy. In vitro studies suggested that transfer across the placenta was minimal 12, 13, 14 and glibenclamide was undetectable in cord blood 15. Early clinical studies suggested there was no significant increase in macrosomia or neonatal hypoglycaemia with the use of glibenclamide compared to insulin use 15, 16, 17, 18, 19, 20, but these studies were limited in their power to demonstrate differences 21.…”

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

confidence: 99%

“…In vitro studies suggested that transfer across the placenta was minimal 12, 13, 14 and glibenclamide was undetectable in cord blood 15. Early clinical studies suggested there was no significant increase in macrosomia or neonatal hypoglycaemia with the use of glibenclamide compared to insulin use 15, 16, 17, 18, 19, 20, but these studies were limited in their power to demonstrate differences 21. In a meta‐analysis (10 studies on 471 women exposed to sulfonylureas and biguanides in the first trimester), no significant difference was found in the rate of major malformations or neonatal death in the offspring of women with exposure to oral antidiabetic agents in the first trimester compared with non‐exposed women, but the meta‐analysis was limited by study heterogeneity 22.…”

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

confidence: 99%

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

confidence: 99%

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

et al. 2017

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“…Glyburide (glibenclamide, INN) (GLY), an oral sulfonylurea hypoglycemic agent, has similar outcomes as insulin when used in the treatment of gestational diabetes mellitus (GDM) [1]. GDM is typically diagnosed in the third trimester of pregnancy and affects up to 8% of all pregnancies [2].…”

Section: Introductionmentioning

confidence: 99%

“…GLY improves glycemic control by increasing the release of insulin from the β cells of the pancreas. When compared to treatment with exogenous insulin, GDM patients on GLY have higher compliance, similar maternal glucose control and similar infant outcomes such as macrosomia and neonatal hypoglycemia [1]. For these reasons, GLY is increasingly used as first-line therapy for GDM.…”

Section: Introductionmentioning

confidence: 99%

Validation of a sensitive LC–MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: An OPRU Network study

Kirby

Hébert

Easterling

et al. 2007

Journal of Chromatography B

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Glyburide (glibenclamide, INN), a second generation sulfonylurea is widely used in the treatment of gestational diabetes mellitus (GDM). None of the previously reported analytical methods provide adequate sensitivity for the expected sub-nanogram/mL maternal and umbilical cord plasma concentrations of glyburide during pregnancy. We developed and validated a sensitive and low sample volume liquid chromatographic-mass spectrometric (LC-MS) method for simultaneous determination of glyburide (GLY) and its metabolite, 4-transhydroxy glyburide (M1) in human plasma (0.5 ml) or urine (0.1 ml). The limits of quantitation (LOQ) for GLY and M1 in plasma were 0.25 and 0.40 ng/mL, respectively whereas it was 1.06 ng/mL for M1 in urine. As measured by quality control samples, precision (% coefficient of variation) of the assay was < 15% whereas the accuracy (% deviation from expected) ranged from −10.1-14.3%. We found that the GLY metabolite, M1 is excreted in the urine as the glucuronide-conjugate.

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“…In United States, there is emerging interest for the use of sulphonylureas, especially glyburide, during pregnancy. In a randomized study comparing glyburide with insulin therapy, women treated with glyburide achieved similar degree of glycaemic control to those in the insulin group [53]. The risks of macrosomia, respiratory distress, neonatal hypoglycaemia and need for neonatal intensive care support were not different between the 2 groups.…”

Section: Oral Anti-hyperglycaemic Agentsmentioning

confidence: 91%

Gestational Diabetes Mellitus: a review of the diagnosis, clinical implications and management

Wong

2013

RHC

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Gestational diabetes mellitus (GDM) is a condition that affects the wellbeing of mother and fetus. Women with GDM are at risk of type 2 diabetes mellitus in the future, while fetal exposure to hyperglycaemia in-utero may affect their glycometabolic profile later in life. Appropriate screening and management of this problem is important in ensuring good pregnancy outcomes. In this review, the clinical implications, the various ways to screen and diagnose GDM, and management strategies during pregnancy will be discussed. For years, insulin is the mainstay of treatment if medical nutrition therapy fails to maintain adequate glycaemic control, but use of other oral pharmacotherapy may gain greater acceptance in the future. Following delivery, ongoing follow-up of these women is worthwhile as early intervention through lifestyle or pharmacotherapy may prevent the development of diabetes.

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A Comparison of Glyburide and Insulin in Women with Gestational Diabetes Mellitus

Abstract: In women with gestational diabetes, glyburide is a clinically effective alternative to insulin therapy.

Cited by 819 publications

References 38 publications

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

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

Validation of a sensitive LC–MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: An OPRU Network study

Gestational Diabetes Mellitus: a review of the diagnosis, clinical implications and management

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