April 22, 2015
Glyburide is thought to be safe for managing gestational diabetes mellitus (GDM), but newborns of women treated with the drug were at increased risk of adverse birth outcomes, according to recent findings, which suggested the mothers did not achieve adequate control of their hyperglycemia.
Investigators studied 4,982 women who took glyburide and 4,191 women who received insulin within 150 days of giving birth from 2000 to 2011. The newborns of women who took glyburide were more likely to require care in a neonatal intensive care unit (NICU), have hypoglycemia, suffer injury during birth, experience respiratory distress, and be larger than normal for gestational age. Glyburide did not increase risks of birth trauma, premature birth, and jaundice, noted the study. Additionally, women on the drug were 3% less likely to require cesarean delivery.
The difference in risk per 100 women associated with glyburide compared with insulin was 2.97% for NICU admission, 1.41% for large for gestational age, and 1.11% for respiratory distress, said the researchers.
Notably, the percentage of women who were prescribed glyburide jumped from 8.5% at the start of the study period to 64.4% at the end, an increase that was consistent with the study’s claim that the use of glyburide has spiked in the last decade.
Treating GDM — cases of which have doubled in the last 20 years, according to the study — with pharmacological interventions lowers risk of associated adverse outcomes in the 10% of women with the condition who are unable to manage high blood glucose levels with diet, exercise, and routine glucose monitoring, noted the researchers. They said insulin is currently the only approved treatment in the United States for GDM, but pointed out that taking a pill of glyburide is easier than being subjected to insulin injections. However, clinical studies have suggested the more patient-friendly option causes trauma during birth, and elevated blood glucose levels and jaundice in newborns.
The findings, which were based on the largest population-based trial in the United States to assess the impact of prescribing glyburide during the actual care of insured women, were consistent with the limited research that showed glyburide caused issues newborns of women with GDM.
“Glyburide is available in pill form, whereas insulin has to be injected,” said Dr. Jonsson Funk, research associate professor of epidemiology at the Gillings School of Public Health at the University of North Carolina in Chapel Hill. “The convenience factor makes glyburide an attractive option for women with gestational diabetes. In light of these findings, I believe we need to better understand which patients can be managed effectively with this drug.”
The study was published online in JAMA Pediatrics.
1. Camelo Castillo W, Boggess K, Sturmer T, Brookhart MA, Benjamin DK Jr, Jonsson Funk M. Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes. JAMA Pediatr. 2015 Mar 30. [Epub ahead of print]