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Glyburide Used for Gestational Diabetes May Increase Risk of Birth Complications

Complications seen in the study included respiratory distress, high birth weight, neonatal intensive care unit admission, and hypoglycemia…

Over the last 10 years, the use of glyburide to treat gestational diabetes has increased. Even though it is easy to use, however, it may not be a good alternative to insulin due to many short- and long-term effects. According to a new study, glyburide when used for gestational diabetes can increase the risk of birth complications, such as respiratory distress, hypoglycemia, high birth weight, and birth injury. The mechanism behind this association is still not clear. Moreover, a cause-and-effect relationship was not established in this study.
Researchers from University of North Carolina, Duke University and the University of Maryland conducted a study using a nationwide, employer-based insurance database. A total of 110,000 women with gestational diabetes were enrolled. Exclusion criteria included women with age under 15 or over 45 years, those with type 1 or type 2 diabetes, and those pregnant with multiples. The percentage of women using glyburide increased from 8.5% to 64% during the study period of 11 years. The study found that there was a higher risk of complications for babies born to mothers on glyburide compared to mothers on insulin. These complications included respiratory distress (1.1% difference) and high birth weight (1.4% difference). These differences may be due to the inadequate blood glucose control experienced in women with glyburide compared to insulin. Until additional safety data is available, it is important to consider alternative therapies to glyburide in gestational diabetes.

About 8 percent of women with gestational diabetes were treated with glyburide or insulin, according to the study. During the study period — 2000 to 2011 — the use of glyburide increased from 8.5 percent to 64 percent, the researchers found.

The study reported a 3 percent difference in the number of babies who needed neonatal intensive care (NICU) admission, with babies born to mothers on glyburide more likely to end up in the NICU than babies born to mothers taking insulin.

Dr. Richard Holt, author of an accompanying editorial in the journal, and a professor of diabetes and endocrinology at the University of Southampton in England, added that, “Glyburide has been used increasingly in pregnancy over the last 10 years. Although the initial trial data suggested it was safe, large studies including this one have raised concerns about the safety of its use.”

The study authors suggested a possible reason for the differences in birth complications may be that women on glyburide don’t have adequate control of blood sugar levels.

Practice Pearls:

  • While this study found an association between the use of glyburide and an increased risk of complications, the study wasn’t designed to show a cause-and-effect relationship.
  • The study found that there was a higher risk of complications for babies born to mothers on glyburide compared to mothers on insulin.
  • Babies born to mothers on glyburide more likely to end up in the NICU than babies born to mothers taking insulin.

Wendy Camelo Castillo. Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes. JAMA Pediatr. Published online March 30, 2015. doi:10.1001/jamapediatrics.2015.74