Glyburide for the Treatment of Gestational Diabetes
A critical appraisal
- Thomas R. Moore, MD
- From the Department of Reproductive Medicine, School of Medicine, University of California San Diego, San Diego, California
- Address correspondence and reprint requests to Thomas R. Moore, MD, Department of Reproductive Medicine, School of Medicine, University of California San Diego, 200 W. Arbor Drive, MPF 170, San Diego, CA 92103. E-mail: trmoore{at}ucsd.edu
- GDM, gestational diabetes mellitus
- LGA, large-for-gestational-age
- NICU, neonatal intensive care unit
It has been over 4 years since a randomized controlled trial was published demonstrating clinical equivalency of glyburide and insulin for management of gestational diabetes mellitus (GDM), yet major specialty bodies continue to advocate caution in adopting oral agents as an acceptable modality for management of GDM. To quote recent policy statements by the American Diabetes Association and the American College of Obstetricians and Gynecologists, “Oral glucose-lowering agents have generally not been recommended during pregnancy… glyburide is not FDA approved for the treatment of GDM and further studies are needed in a larger patient population to establish its safety” (1).
“At this time, no other oral agent has been shown to be safe and effective in GDM, and this study has not been confirmed. Further study is recommended before the use of newer oral hypoglycemic agents can be supported for use in pregnancy” (2).
The aim of this review is to critically evaluate existing evidence regarding use of glyburide in GDM management accumulating since the publication of the randomized controlled trial by Langer et al. (3).
RANDOMIZED CONTROLLED TRIAL OF GLYBURIDE AND INSULIN—
Despite significant concerns regarding teratogenicity (4) and severe neonatal hypoglycemia associated with the use of oral hypoglycemic drugs during pregnancy, especially sulfonylureas (5), Elliott et al. (6) demonstrated that minimal glyburide was detectable crossing the placenta in an in vitro perfusion model, whereas considerable transplacental drug transfer had been documented in earlier sulfonylurea agents (7,8).
Based on these observations, Langer et al. randomized 404 women with GDM to glyburide or insulin treatment. Study eligibility was limited to women with GDM who had fasting plasma glucose concentrations between 95 and 140 mg/dl and were at 11–33 weeks of gestation. Women with fasting plasma glucose concentrations of <95 mg/dl were initially treated with diet but were subsequently enrolled if their …
