March 30, 2015
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Risk for adverse neonatal outcomes linked to glyburide

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Gestational diabetes has been increasingly treated with glyburide; however, the medication is associated with a higher risk for newborns to be admitted to the neonatal ICU, have respiratory distress, hypoglycemia, and birth injury and be large for gestational age compared with newborns from mothers treated with insulin, according to recent findings.

“The convenience factor makes glyburide an attractive option for women with gestational diabetes, but, in light of these findings, we need to better understand which patients can be managed effectively with this drug,” Michele Jonsson Funk, PhD, of the University of North Carolina at Chapel Hill, told Endocrine Today.

Michele Jonsson Funk

Michele Jonsson Funk

Funk with Wendy Camelo Castillo, PhD, also of the University of North Carolina at Chapel Hill, and colleagues evaluated 110,879 women with gestational diabetes from a nationwide U.S. employer-based insurance claims database from 2000 to 2011 to determine the risk for adverse maternal and neonatal outcomes in these women treated with glyburide or insulin.

Overall, 8.3% of participants were treated with glyburide (n = 4,982) or insulin (n = 4,191).

Hypothyroidism and infertility treatment were more common among the insulin group, whereas obesity and hospitalization were more common in the glyburide group.

Wendy Camelo Castillo

Wendy Camelo Castillo

A higher risk for admission to the neonatal ICU (adjusted RR [aRR] = 1.41; 95% CI, 1.23-1.62), respiratory distress (aRR = 1.63; 95% CI, 1.23-2.15), neonatal hypoglycemia (aRR = 1.4; 95% CI, 1-1.95), birth injury (aRR = 1.35; 95% CI, 1-1.82) and large for gestational age (aRR = 1.43; 95% CI, 1.16-1.76) were more common among newborns born to the glyburide group compared with those born to the insulin group. However, the glyburide group was not at increased risk for obstetrical trauma (aRR = 0.92; 95% CI, 0.71-1.2), preterm birth (aRR = 1.06; 95% CI, 0.93-1.21) or jaundice (aRR = 0.96; 95% CI, 0.48-1.91). The glyburide group had a 3% lower risk for cesarean delivery compared with the insulin group (aRR = 0.97; 95% CI, 0.93-1).

“After accounting for maternal comorbidities and risk factors for neonatal outcomes, we found an association between glyburide (compared with insulin) and elevated risk of NICU admission, neonatal hypoglycemia, respiratory distress, birth injury and large for gestation age in women with [gestational diabetes],” the researchers wrote. “These results are consistent with findings from prior studies and suggest that women with [gestational diabetes] being treated with glyburide may not be achieving adequate glucose control.”

In an accompanying editorial, Richard I. G. Holt, PhD, FRCP, of the University of Southampton in England, wrote that the study highlights the need to address concerns about the use of glyburide for treatment of gestational diabetes.

“As the authors rightly conclude, the ‘higher risk of neonatal outcomes associated with glyburide-treated women demands further attention’ and more attention is needed to determine which women are most likely to benefit from glyburide or perhaps more importantly not be harmed,” he wrote. “It is time for a pause for thought.” – by Amber Cox

Disclosure: Jonsson Funk, Camelo Castillo and Holt report no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.